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1. Dugoua JJ, Wu P, Seely D, Eyawo O, Mills E: Astragalus-containing Chinese herbal combinations for advanced non-small-cell lung cancer: a meta-analysis of 65 clinical trials enrolling 4751 patients. Lung Cancer (Auckl); 2010;1:85-100

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Astragalus-containing Chinese herbal combinations for advanced non-small-cell lung cancer: a meta-analysis of 65 clinical trials enrolling 4751 patients.
  • BACKGROUND: Non-small-cell lung cancer (NSCLC) is a leading cause of death.
  • METHODS: We conducted a comprehensive systematic review of all published randomized clinical trials (RCTs) evaluating astragalus-based herbal preparations in NSCLC patients.
  • We abstracted data independently, in duplicate on studies reporting of methods, survival outcomes, tumor responses, and performance score responses.
  • We applied a random-effects meta-analysis and report outcomes as relative risks (RR) with 95% confidence intervals (CIs).
  • All trials included the herbal preparations plus platinum-based chemotherapy versus chemotherapy alone.
  • We pooled 7 studies (n = 529) reporting on survival at 6 months and found a pooled RR of 0.54 (95% CI, 0.45 to 0.65, <i>P</i> ≤ 0.0001).
  • We included 20 trials (n = 1520) on survival at 12 months and found a pooled RR of 0.65 (95% CI, 0.54 to 0.79, <i>P</i> ≤ 0.0001).
  • When we applied a composite endpoint of any tumor treatment response, we pooled data from 57 trials and found a pooled RR of 1.35 in favor of herbal treatment (95% CI, 1.26 to 1.44, <i>P</i> ≤ 0.0001).
  • CONCLUSIONS: We found a large treatment effect of adding astragalus-based herbal treatment to standard chemotherapy regimens.
  • There is a pressing need for validation of these findings in well-conducted RCTs in a Western setting.

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  • (PMID = 28210109.001).
  • [Journal-full-title] Lung Cancer (Auckland, N.Z.)
  • [ISO-abbreviation] Lung Cancer (Auckl)
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] New Zealand
  • [Keywords] NOTNLM ; astralagus / herbal preparations / non-small-cell lung cancer
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2. Schwartz GL, Turner ST: Screening for primary aldosteronism in essential hypertension: diagnostic accuracy of the ratio of plasma aldosterone concentration to plasma renin activity. Clin Chem; 2005 Feb;51(2):386-94
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • Uncertainty exists, however, regarding its diagnostic accuracy and the effects of antihypertensive drugs and dietary sodium balance on test characteristics.
  • Measurements were made while individuals were on antihypertensive drug therapy, after a 2-week drug-free period, after 4 days of dietary sodium loading, and after acute furosemide diuresis.
  • We measured 24-h urine aldosterone excretion and PRA on the 4th day of dietary sodium loading to establish the diagnosis of primary aldosteronism.
  • ROC curves were constructed for ratios measured under each clinical condition, and likelihood ratios were determined for individuals on or off antihypertensive drug therapy.
  • When measured on and off antihypertensive drug therapy, the 95% CIs for the optimum cutpoint for the ratio overlapped.
  • Point estimates of sensitivity on and off therapy were 73% (95% CI, 50-96%) and 87% (70-100%), respectively, and specificities were 74% (65-83%) and 75% (66-84%).
  • CONCLUSIONS: The aldosterone:PRA ratio provides only fair diagnostic accuracy in screening for primary aldosteronism, but concomitant antihypertensive drug therapy or acute variation in dietary sodium balance does not adversely affect test accuracy.
  • Reporting of likelihood ratios associated with ranges of values of the aldosterone:PRA ratio, rather than use of a single "optimum" cutpoint, may enhance the usefulness of the test.
  • [MeSH-major] Aldosterone / blood. Hyperaldosteronism / diagnosis. Hypertension / blood. Renin / blood
  • [MeSH-minor] Adult. Antihypertensive Agents / therapeutic use. Female. Humans. Male. Middle Aged. Plasma. Prevalence. Reference Standards. Sodium, Dietary


3. Damasceno A, Azevedo A, Silva-Matos C, Prista A, Diogo D, Lunet N: Hypertension prevalence, awareness, treatment, and control in mozambique: urban/rural gap during epidemiological transition. Hypertension; 2009 Jul;54(1):77-83
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Hypertension prevalence, awareness, treatment, and control in mozambique: urban/rural gap during epidemiological transition.
  • In 2005 we evaluated a nationally representative sample of the Mozambican population (n=3323; 25 to 64 years old) following the Stepwise Approach to Chronic Disease Risk Factor Surveillance.
  • Prevalence of hypertension (systolic blood pressure > or =140 mm Hg and/or diastolic blood pressure > or =90 mm Hg and/or antihypertensive drug therapy), awareness (having been informed of the hypertensive status by a health professional in the previous year), treatment among the aware (use of antihypertensive medication in the previous fortnight), and control among those treated (blood pressure <140/90 mm Hg) were 33.1% (women: 31.2%; men: 35.7%), 14.8% (women: 18.4%; men: 10.6%), 51.9% (women: 61.1%; men: 33.3%), and 39.9% (women: 42.9%; men: 28.7%), respectively.
  • Urban/rural comparisons are presented as age- and education-adjusted odds ratios (ORs) and 95% CIs.
  • Treatment prevalence was not significantly different across urban/rural settings (women: OR: 1.4, 95% CI: 0.5 to 4.4; men: OR: 0.3, 95% CI: 0.1 to 1.4).
  • Our results illustrate the changing paradigms of "diseases of affluence" and the dynamic character of epidemiological transition.
  • The urban/rural differences across sexes support a trend toward smaller differences, emphasizing the need for strategies to improve prevention, correct diagnosis, and access to effective treatment.
  • [MeSH-major] Hypertension / drug therapy. Hypertension / prevention & control
  • [MeSH-minor] Adult. Aged. Alcohol Drinking. Antihypertensive Agents / therapeutic use. Blood Pressure / drug effects. Body Mass Index. Diet. Educational Status. Female. Health Knowledge, Attitudes, Practice. Humans. Male. Middle Aged. Mozambique / epidemiology. Prevalence. Rural Health / statistics & numerical data. Smoking Cessation. Urban Health / statistics & numerical data. Waist-Hip Ratio. Weight Loss

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  • (PMID = 19470872.001).
  • [ISSN] 1524-4563
  • [Journal-full-title] Hypertension (Dallas, Tex. : 1979)
  • [ISO-abbreviation] Hypertension
  • [Language] eng
  • [Publication-type] Journal Article; Research Support, Non-U.S. Gov't
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Antihypertensive Agents
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4. Corrao G, Zambon A, Parodi A, Mezzanzanica M, Merlino L, Cesana G, Mancia G: Do socioeconomic disparities affect accessing and keeping antihypertensive drug therapy? Evidence from an Italian population-based study. J Hum Hypertens; 2009 Apr;23(4):238-44
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  • [Title] Do socioeconomic disparities affect accessing and keeping antihypertensive drug therapy? Evidence from an Italian population-based study.
  • We conducted this population-based cohort study by linking several databases to explore the role of socioeconomic position for accessing and keeping antihypertensive drug therapy.
  • A total of 71 469 patients, residents in the city of Milan (Italy) aged 40-80 years, who received an antihypertensive drug during 1999-2002 were followed for 1 year starting from the first dispensation.
  • Socioeconomic position and drug prescriptions were respectively obtained from tax registry and outpatient prescription database.
  • The effect of socioeconomic characteristics on standardized incidence rate (SIR) of new users of antihypertensive agents, odds ratio (OR) of using combined antihypertensive agents and non-antihypertensive drugs and hazard ratio (HR) of discontinuing antihypertensive therapy were estimated after adjustment for potential confounders.
  • Compared to persons at the highest income, those at the lowest income had increased chances of starting with combined antihypertensive drugs (OR: 1.1; 95% confidence intervals (CIs): 1.0, 1.2), and of using drugs for heart failure (OR:1.5; CIs:1.3, 1.6) and diabetes (OR: 1.7; CIs: 1.6, 1.9).
  • Compared with Italians, non-western immigrants had increased chances of starting with combined antihypertensive agents (OR: 1.2; CIs: 1.0, 1.3), of using drugs for heart failure (OR: 1.2; CIs: 1.0, 1.4) and for diabetes (OR: 1.8; CIs: 1.6, 2.1), and of interrupting antihypertensive therapy (HR: 1.1; 95% CIs: 1.0, 1.2).
  • Despite the universal health coverage of the Italian National Health Service (NHS), social disparities affect accessing and keeping antihypertensive therapy.
  • [MeSH-major] Antihypertensive Agents / supply & distribution. Hypertension / drug therapy

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  • (PMID = 18668127.001).
  • [ISSN] 1476-5527
  • [Journal-full-title] Journal of human hypertension
  • [ISO-abbreviation] J Hum Hypertens
  • [Language] eng
  • [Publication-type] Journal Article; Research Support, Non-U.S. Gov't
  • [Publication-country] England
  • [Chemical-registry-number] 0 / Antihypertensive Agents
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5. Baxter H, Winder R, Chalder M, Wright C, Sherlock S, Haase A, Wiles NJ, Montgomery AA, Taylor AH, Fox KR, Lawlor DA, Peters TJ, Sharp DJ, Campbell J, Lewis G: Physical activity as a treatment for depression: the TREAD randomised trial protocol. Trials; 2010 Nov 12;11:105
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  • [Title] Physical activity as a treatment for depression: the TREAD randomised trial protocol.
  • Whilst antidepressants have been shown to be clinically effective, many patients and healthcare professionals would like to access other forms of treatment as an alternative or adjunct to drug therapy for depression.
  • A recent systematic review presented some evidence that physical activity could offer one such option, although further investigation is needed to test its effectiveness within the context of the National Health Service.The aim of this paper is to describe the protocol for a randomised, controlled trial (RCT) designed to evaluate an intervention developed to increase physical activity as a treatment for depression within primary care.
  • METHODS/DESIGN: The TREAD study is a pragmatic, multi-centre, two-arm RCT which targets patients presenting with a new episode of depression.
  • Only those patients with a confirmed diagnosis of a depressive episode as assessed by the Clinical Interview Schedule-Revised (CIS-R), a Beck Depression Inventory (BDI) score of at least 14 and informed written consent were included in the study.
  • Eligible patients were individually randomised to one of two treatment groups; usual GP care or usual GP care plus facilitated physical activity.
  • The primary outcome of the trial is clinical symptoms of depression assessed using the BDI four months after randomisation.
  • Outcomes will be analysed on an intention-to-treat (ITT) basis and will use linear and logistic regression models to compare treatments.
  • DISCUSSION: The results of the trial will provide information about the effectiveness of physical activity as a treatment for depression.
  • Given the current prevalence of depression and its associated economic burden, it is hoped that TREAD will provide a timely contribution to the evidence on treatment options for patients, clinicians and policy-makers.
  • [MeSH-major] Depression / therapy. Exercise

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  • (PMID = 21073712.001).
  • [ISSN] 1745-6215
  • [Journal-full-title] Trials
  • [ISO-abbreviation] Trials
  • [Language] eng
  • [Databank-accession-numbers] ISRCTN/ ISRCTN16900744
  • [Grant] United Kingdom / Medical Research Council / / G0600705; United Kingdom / Medical Research Council / / G0800800; United Kingdom / Department of Health / /
  • [Publication-type] Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
  • [Publication-country] England
  • [Other-IDs] NLM/ PMC2993700
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6. Yun O, Lima MA, Ellman T, Chambi W, Castillo S, Flevaud L, Roddy P, Parreño F, Albajar Viñas P, Palma PP: Feasibility, drug safety, and effectiveness of etiological treatment programs for Chagas disease in Honduras, Guatemala, and Bolivia: 10-year experience of Médecins Sans Frontières. PLoS Negl Trop Dis; 2009 Jul 07;3(7):e488
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  • [Title] Feasibility, drug safety, and effectiveness of etiological treatment programs for Chagas disease in Honduras, Guatemala, and Bolivia: 10-year experience of Médecins Sans Frontières.
  • BACKGROUND: Chagas disease (American trypanosomiasis) is a zoonotic or anthropozoonotic disease caused by the parasite Trypanosoma cruzi.
  • Predominantly affecting populations in poor areas of Latin America, medical care for this neglected disease is often lacking.
  • Médecins Sans Frontières/Doctors Without Borders (MSF) has provided diagnostic and treatment services for Chagas disease since 1999.
  • This report describes 10 years of field experience in four MSF programs in Honduras, Guatemala, and Bolivia, focusing on feasibility protocols, safety of drug therapy, and treatment effectiveness.
  • METHODOLOGY: From 1999 to 2008, MSF provided free diagnosis, etiological treatment, and follow-up care for patients <18 years of age seropositive for T. cruzi in Yoro, Honduras (1999-2002); Olopa, Guatemala (2003-2006); Entre Ríos, Bolivia (2002-2006); and Sucre, Bolivia (2005-2008).
  • Essential program components guaranteeing feasibility of implementation were information, education, and communication (IEC) at the community and family level; vector control; health staff training; screening and diagnosis; treatment and compliance, including family-based strategies for early detection of adverse events; and logistics.
  • Chagas disease diagnosis was confirmed by testing blood samples using two different diagnostic tests. T. cruzi-positive patients were treated with benznidazole as first-line treatment, with appropriate counseling, consent, and active participation from parents or guardians for daily administration of the drug, early detection of adverse events, and treatment withdrawal, when necessary.
  • Weekly follow-up was conducted, with adverse events recorded to assess drug safety.
  • Evaluations of serological conversion were carried out to measure treatment effectiveness.
  • RESULTS: Total numbers of children and adolescents tested for T. cruzi in Yoro, Olopa, Entre Ríos, and Sucre were 24,471, 8,927, 7,613, and 19,400, respectively.
  • Patients were treated with benznidazole, and early findings of seroconversion varied widely between the Central and South American programs: 87.1% and 58.1% at 18 months post-treatment in Yoro and Olopa, respectively; 5.4% by up to 60 months in Entre Ríos; and 0% at an average of 18 months in Sucre.
  • No deaths occurred in the treatment population.
  • CONCLUSIONS: These results demonstrate the feasibility of implementing Chagas disease diagnosis and treatment programs in resource-limited settings, including remote rural areas, while addressing the limitations associated with drug-related adverse events.
  • The variability in apparent treatment effectiveness may reflect differences in patient and parasite populations, and illustrates the limitations of current treatments and measures of efficacy.
  • New treatments with improved safety profiles, pediatric formulations of existing and new drugs, and a faster, reliable test of cure are all urgently needed.
  • [MeSH-major] Chagas Disease / drug therapy. Chagas Disease / epidemiology. Nitroimidazoles / adverse effects. Nitroimidazoles / therapeutic use. Trypanocidal Agents / adverse effects. Trypanocidal Agents / therapeutic use. Trypanosoma cruzi / drug effects
  • [MeSH-minor] Adolescent. Animals. Bolivia / epidemiology. Child. Child, Preschool. Developing Countries. Education. Female. Follow-Up Studies. Guatemala / epidemiology. Honduras / epidemiology. Humans. Infant. Insect Control. Male. Treatment Outcome

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  • (PMID = 19582142.001).
  • [ISSN] 1935-2735
  • [Journal-full-title] PLoS neglected tropical diseases
  • [ISO-abbreviation] PLoS Negl Trop Dis
  • [Language] eng
  • [Publication-type] Journal Article; Research Support, Non-U.S. Gov't
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Nitroimidazoles; 0 / Trypanocidal Agents; YC42NRJ1ZD / benzonidazole
  • [Other-IDs] NLM/ PMC2700957
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7. Girelli D, Martinelli N, Olivieri O, Pizzolo F, Friso S, Faccini G, Bozzini C, Tenuti I, Lotto V, Villa G, Guarini P, Trabetti E, Pignatti PF, Mazzucco A, Corrocher R: Hyperhomocysteinemia and mortality after coronary artery bypass grafting. PLoS One; 2006;1:e83
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  • BACKGROUND: The independent prognostic impact, as well as the possible causal role, of hyperhomocysteinemia (HHcy) in coronary artery disease (CAD) is controversial.
  • After multiple adjustment for other univariate predictors by Cox regression, including statin therapy (the most powerful predictor in uni-/multivariate analyses), high-sensitivity C Reactive Protein (hs-CRP) levels, and all known major genetic (MTHFR 677C-->T polymorphism) and non-genetic (B-group vitamin status and renal function) tHcy determinants, HHcy remained an independent prognostic factor for mortality (HRs: 5.02, 95% CIs 1.88 to 13.42, P = 0.001).
  • CONCLUSIONS: HHcy is an important prognostic marker after CABG, independent of modern drug therapy and biomarkers.
  • [MeSH-major] Coronary Artery Bypass / mortality. Coronary Artery Disease / complications. Coronary Artery Disease / surgery. Hyperhomocysteinemia / complications

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  • (PMID = 17183715.001).
  • [ISSN] 1932-6203
  • [Journal-full-title] PloS one
  • [ISO-abbreviation] PLoS ONE
  • [Language] eng
  • [Publication-type] Journal Article; Research Support, Non-U.S. Gov't
  • [Publication-country] United States
  • [Chemical-registry-number] 0LVT1QZ0BA / Homocysteine; EC 1.5.1.20 / Methylenetetrahydrofolate Reductase (NADPH2)
  • [Other-IDs] NLM/ PMC1762373
  • [General-notes] NLM/ Original DateCompleted: 20070801
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8. Lee MS, Shin BC, Ernst E: Acupuncture for Alzheimer's disease: a systematic review. Int J Clin Pract; 2009 Jun;63(6):874-9
PubMed Health. DARE review .

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Acupuncture for Alzheimer's disease: a systematic review.
  • BACKGROUND: Acupuncture is often used as a treatment for dementia and is claimed to be effective in improving intelligence.
  • AIMS: The objective of this review is to assess the clinical evidence for or against acupuncture as a treatment for Alzheimer's disease (AD).
  • We included all randomised clinical trials (RCTs) of needle acupuncture to treat human patients suffering from AD.
  • Two RCTs assessed the effectiveness of acupuncture on cognitive function compared with drug therapy.
  • Their results suggested no significant effect in favour of acupuncture [n = 72, weight mean difference (WMDs), -0.55; 95% confidence intervals (CIs) -1.31 to 0.21, p = 0.15, heterogeneity: tau(2) = 0, chi(2) = 0.048, p = 0.49, I(2) = 0%].
  • One RCT reported favourable effects of drug therapy compared with acupuncture for ADL, while the other failed to so.
  • The meta-analysis of these data showed significant effects of drug therapy compared with acupuncture (n = 72, WMD, -1.29; 95% CIs: -1.77 to -0.80, p < 0.001, heterogeneity: tau(2) = 0, chi(2) = 0.17, p = 0.68, I(2) = 0%).
  • [MeSH-major] Acupuncture Therapy. Alzheimer Disease / therapy
  • [MeSH-minor] Activities of Daily Living. Female. Humans. Male. Randomized Controlled Trials as Topic. Treatment Outcome

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  • (PMID = 19490197.001).
  • [ISSN] 1742-1241
  • [Journal-full-title] International journal of clinical practice
  • [ISO-abbreviation] Int. J. Clin. Pract.
  • [Language] eng
  • [Publication-type] Evaluation Studies; Journal Article; Meta-Analysis; Research Support, Non-U.S. Gov't; Review
  • [Publication-country] England
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9. Lee MS, Yang EJ, Kim JI, Ernst E: Ginseng for cognitive function in Alzheimer's disease: a systematic review. J Alzheimers Dis; 2009;18(2):339-44
PubMed Health. DARE review .

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Ginseng for cognitive function in Alzheimer's disease: a systematic review.
  • The objective of this review is to assess the clinical evidence for or against ginseng as a treatment for Alzheimer's disease (AD).
  • We searched 20 databases from their inception to January 2009 and included all randomized clinical trials (RCTs) of any type of Panax ginseng to treat human patients suffering from AD.
  • They assessed the effectiveness of ginseng as an adjunct to drug therapy on cognitive function compared with conventional drug therapy.
  • Their results suggested significant effect in favor of ginseng on the Mini-Mental Status Examination (n = 174, weight mean difference (WMD), 1.85; 95% confidence intervals, CIs 0.88 to 2.82, P = 0.0002) and on the Alzheimer's Disease Assessment Scale (ADAS)-cognitive (n = 174, WMD, 3.09; 95% CIs 1.08 to 5.09, P = 0.003).
  • In conclusion, the evidence for ginseng as a treatment of AD is scarce and inconclusive.
  • [MeSH-major] Alzheimer Disease / complications. Cognition Disorders / drug therapy. Cognition Disorders / etiology. Panax / chemistry. Phytotherapy / methods. Plant Extracts / therapeutic use


10. Scheid DC, Hamm RM, Stevens KW: Cost effectiveness of human immunodeficiency virus postexposure prophylaxis for healthcare workers. Pharmacoeconomics; 2000 Oct;18(4):355-68
COS Scholar Universe. author profiles.

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • METHODS: A decision tree incorporating a Markov model was created for 4 PEP strategies: the current USPHS recommendations, triple drug therapy, zidovudine monotherapy or no prophylaxis.
  • Confidence intervals (CIs) around cost-effectiveness estimates were estimated by a bootstrapping method.
  • RESULTS: The costs (in 1997 US dollars) per quality-adjusted life-year (QALY) save by each strategy were as follows: monotherapy $US688 (95% CI: $US624 to $US750); USPHS recommendations $US5211 (95% CI: $US5126 to $US5293); and triple drug therapy $US8827 (95% CI: $US8715 to $US8940).
  • The marginal cost per year of life saved was: USPHS recommendations $US81 987 (95% CI: $US80 437 to $US83 689); triple drug therapy $US970 451 (95% CI: $US924 786 to $US 1 014 429).
  • Sensitivity testing showed that estimates of the probability of seroconversion for each category of exposure were most influential, but did not change the order of strategies in the baseline analysis.
  • With the prolonged HIV stage durations and increased costs associated with recent innovations in HIV therapy, the marginal cost effectiveness of the USPHS PEP strategy was decreased to $US62 497/QALY saved.
  • CONCLUSIONS: Current USPHS PEP recommendations are marginally cost effective compared with monotherapy, but the additional efficacy of triple drug therapy for all risk categories is rewarded by only a small reduction in HIV infections at great expense.
  • For the foreseeable future, assuming innovations in therapy that employ expensive drug combinations earlier in the HIV disease course to extend life expectancy and the increasing prevalence of HIV drug resistance, our model supports the use of the USPHS PEP guidelines.
  • [MeSH-major] HIV Infections / prevention & control. Health Personnel. Occupational Diseases / prevention & control

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  • (PMID = 15344304.001).
  • [ISSN] 1170-7690
  • [Journal-full-title] PharmacoEconomics
  • [ISO-abbreviation] Pharmacoeconomics
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] New Zealand
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11. Racioppi M, Cappa E, Volpe A, D'Agostino D, Bassi PF: [Integrated treatment with hyperthermia and chemotherapy for non-muscle invasive bladder cancer]. Urologia; 2009 Apr-Jun;76(2):61-5

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] [Integrated treatment with hyperthermia and chemotherapy for non-muscle invasive bladder cancer].
  • Oncology-applied hyperthermia is a very old form of therapy.
  • In recent years hyperthermia has been investigated with the aim of improving the treatment for non-muscle invasive bladder cancer to prevent relapse and disease progression, in association with mitomycin-C, a well-known chemotherapeutic agent, to enhance its effect.
  • Target patients are those with non-muscle invasive transitional cell carcinoma, showing medium (Ta-T1, G1-2, multifocal, diameter >3 cm) or high (T1, G3, multifocal or rapidly relapsing, CIS) risk for recurrence or progression.
  • The treatment may be prophylactic following tumor eradication, or ablative when tumor cannot be otherwise eradicated.
  • Several studies have shown the benefits of thermochemotherapy with lower risk for relapse than other treatment options, and 66-80% complete responses following ablative treatment.
  • This association of treatments has a synergic therapeutic effect, higher than administering hyperthermia and drug therapy as single treatment.

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  • (PMID = 21086297.001).
  • [ISSN] 1724-6075
  • [Journal-full-title] Urologia
  • [ISO-abbreviation] Urologia
  • [Language] ita
  • [Publication-type] English Abstract; Journal Article
  • [Publication-country] United States
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12. Barbato A, D'Avanzo B: Marital therapy for depression. Cochrane Database Syst Rev; 2006;(2):CD004188
MedlinePlus Health Information. consumer health - Family Issues.

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Marital therapy for depression.
  • BACKGROUND: Marital therapy for depression has the two-fold aim of modifying negative interaction patterns and increasing mutually supportive aspects of couple relationships, thus changing the interpersonal context linked to depression.
  • To conduct a meta-analysis of all intervention studies comparing marital therapy to other psychosocial and pharmacological treatments, or to non-active treatments.
  • 3. To assess the overall effectiveness of marital therapy as a treatment for depression.
  • 4. To identify mediating variables through which marital therapy is effective in depression treatment.
  • SELECTION CRITERIA: Randomised controlled trials examining the effectiveness of marital therapy versus individual psychotherapy, drug therapy or waiting list/no treatment/minimal treatment for depression were included in the review.
  • Dichotomous data were pooled using the relative risk (RR), and continuous data were pooled using the standardised mean difference (SMD), and 95% confidence intervals (CIs) were calculated.
  • No significant difference in effect was found between marital therapy and individual psychotherapy, either for the continuous outcome of depressive symptoms, based on six studies: SMD -0.12 (95% CI -0.56 to 0.32), or the dichotomous outcome of proportion of subjects remaining at caseness level, based on three studies: RR 0.84 (95% CI 0.32 to 2.22).
  • In comparison with drug therapy, a lower drop-out rate was found for marital therapy: RR 0.31 (95% CI 0.15 to 0.61), but this result was greatly influenced by a single study.
  • The comparison with no/minimal treatment, showed a large significant effect in favour of marital therapy for depressive symptoms, based on two studies: SMD -1.28 (95% CI -1.85 to -0.72) and a smaller significant effect for persistence of depression, based on one study only.
  • AUTHORS' CONCLUSIONS: There is no evidence to suggest that marital therapy is more or less effective than individual psychotherapy or drug therapy in the treatment of depression.
  • Improvement of relations in distressed couples might be expected from marital therapy.
  • Future trials should test whether marital therapy is superior to other interventions for distressed couples with a depressed partner, especially considering the role of potential effect moderators in the improvement of depression.
  • [MeSH-major] Depression / therapy. Interpersonal Relations. Marital Therapy

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  • (PMID = 16625597.001).
  • [ISSN] 1469-493X
  • [Journal-full-title] The Cochrane database of systematic reviews
  • [ISO-abbreviation] Cochrane Database Syst Rev
  • [Language] eng
  • [Publication-type] Journal Article; Meta-Analysis; Review
  • [Publication-country] England
  • [Number-of-references] 52
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13. Czeizel AE, Puhó EH, Acs N, Bánhidy F: High fever-related maternal diseases as possible causes of multiple congenital abnormalities: a population-based case-control study. Birth Defects Res A Clin Mol Teratol; 2007 Jul;79(7):544-51
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] High fever-related maternal diseases as possible causes of multiple congenital abnormalities: a population-based case-control study.
  • BACKGROUND: Multiple congenital abnormalities (MCAs) represent the most severe category of structural birth defects; therefore, we decided to evaluate the possible etiological factors for MCAs.
  • An association was found between a higher risk for MCAs and high fever-related influenza, common cold with secondary complications, tonsillitis, and recurrent orofacial herpes (adjusted ORs with 95% CIs: 2.3, 1.8-2.9).
  • However, the risk for MCAs was reduced by antifever drug therapy (adjusted OR with 95% CI: 1.6, 0.9-2.9).
  • CONCLUSIONS: An association was found between high fever-related maternal diseases and a higher risk for MCAs; however, a certain portion of these MCAs is preventable by antifever therapy.

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  • [Copyright] (c) 2007 Wiley-Liss, Inc.
  • (PMID = 17457825.001).
  • [ISSN] 1542-0752
  • [Journal-full-title] Birth defects research. Part A, Clinical and molecular teratology
  • [ISO-abbreviation] Birth Defects Res. Part A Clin. Mol. Teratol.
  • [Language] eng
  • [Publication-type] Comparative Study; Journal Article; Research Support, Non-U.S. Gov't
  • [Publication-country] United States
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14. Johnson AD, Wang D, Sadee W: Polymorphisms affecting gene regulation and mRNA processing: broad implications for pharmacogenetics. Pharmacol Ther; 2005 Apr;106(1):19-38
The Lens. Cited by Patents in .

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • Intensive studies on polymorphisms affecting drug response have revealed multiple modes of altered gene function, frequently involving cis-acting regulatory sequence variants.
  • Here, a survey of polymorphisms in drug-related genes indicates that: (a) a substantial proportion of genetic variability still remains unaccounted for;.
  • Pharmacogenetic optimiziation of individual drug therapy may require a complete understanding of all functional sequence variants in key genes.
  • This review surveys known noncoding polymorphisms in genes encoding cytochrome P450s and other drug-metabolizing enzymes, drug transporters, and drug targets and receptors.

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  • (PMID = 15781120.001).
  • [ISSN] 0163-7258
  • [Journal-full-title] Pharmacology & therapeutics
  • [ISO-abbreviation] Pharmacol. Ther.
  • [Language] eng
  • [Grant] United States / NIDA NIH HHS / DA / DA018744
  • [Publication-type] Journal Article; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, P.H.S.; Review
  • [Publication-country] England
  • [Chemical-registry-number] 0 / Carrier Proteins; 0 / Pharmaceutical Preparations; 0 / RNA, Messenger; 9035-51-2 / Cytochrome P-450 Enzyme System
  • [Number-of-references] 253
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15. Bouzid K, Ferhat R, Bounedjar A, Mahfouf H, Smaili F, Adjali K: Intravesical gemcitabine (G) single agent as adjuvant chemotherapy in superficial transitional cell carcinoma (TCC) of bladder. J Clin Oncol; 2004 Jul 15;22(14_suppl):4601

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Intravesical gemcitabine (G) single agent as adjuvant chemotherapy in superficial transitional cell carcinoma (TCC) of bladder.
  • : 4601 Background: Intravesical G (2000 mg twice weekly) has been shown in a phase I study to be a safe regimen in bacillus Calmette-Guerin (BCG) refractory TCC (Dalbagni G et al.
  • The objectives of this trial were to evaluate the toxicity and efficacy of intravesical G as adjuvant chemotherapy in patients (pts) with superficial TCC of the bladder.
  • METHODS: Chemonaive pts with histological diagnosis of TCC confirmed by total (ultrasonographic control) transurethral resection (TUR) received intravesical G 2000 mg/week diluted (inbuffered) in 100 ml of saline solution once weekly for 6 weeks.
  • Efficacy was evaluated three months after the end of treatment by ultrasonography, cytology, and TUR with bladder biopsy.
  • There were 9 pts with carcinoma in situ and 20 pts with pT1 lesions.
  • After 348 total instillations (6 months of treatment), 29 pts were evaluable for toxicity in WHO scale.
  • Grade 1 hematologic toxicities were anemia (9%), leucopenia (8%) and thrombocytopenia ( 0,5% ) 2 pts. after a median follow-up time of 12 months ( range 3-15 months), all 29 pts were in complete remission without superficial bladder carcinoma-related events.
  • CONCLUSIONS: G as adjuvant intravesical chemotherapy in superficial TCC of the bladder is safe, with minimal toxicity even after repeated instillations.

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  • (PMID = 28015714.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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16. Hilbig A, Stieler J, Pelzer U, Okenga J, Hintze R, Roll L, Gövercin M, Arning M, Riess H, Oettle H: Phase II study of gemcitabine, cisplatin, folinic acid (FA) and infusional 5-fluorouracil (5-FU) in patients with inoperable esophageal cancer (IEC). J Clin Oncol; 2004 Jul 15;22(14_suppl):4238

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Phase II study of gemcitabine, cisplatin, folinic acid (FA) and infusional 5-fluorouracil (5-FU) in patients with inoperable esophageal cancer (IEC).
  • : 4238 Background: Our previous phase I study has shown that combination chemotherapy with gemcitabine, 5-FU/FA, and cisplatin (GFFC) is feasible and has encouraging activity in IEC.
  • Therefore, we initiated a multicenter phase II study of outpatient GFFC treatment for IEC.
  • METHODS: A two-stage design was used, 11 or more of the first 25 evaluable patients (pts) were required to achieve at least SD to complete enrolment to a total of 66 pts.
  • Treatment consists of cisplatin 30 mg/m<sup>2</sup> (90 min), gemcitabine 1000 mg/m<sup>2</sup> (30 min), FA 200 mg/m<sup>2</sup> (30 min), and 5-FU 750 mg/m<sup>2</sup> (24h) on days 1 + 8 q3w.
  • Two pts had stage IIB, 17 stage III, 9 stage IVA and 13 stage IVB.
  • Among the first 25 evaluable patients we observed 1 CR, 7 PR, 12 SD and 5 PD, for an objective response rate of 32% (CR+PR+SD 80%).
  • We therefore opened the second stage of our study, and recruitment is ongoing.
  • 3 pts showed non-hematologic toxicities grade 3, 8 pts had non-hematologic toxicities grade 4 including 4 urea, 2 AP, 2 transaminases.
  • CONCLUSION: Our preliminary phase II data indicate that the GFFC regimen has manageable toxicity and is active in patients with IEC.
  • Updated results will be available at the time of the meeting.

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  • (PMID = 28014021.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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17. Nunez L, Isla D, Rosell R, Taron M, Artal A, Bover I, Alberola V, Camps C, Sanchez JJ, Munoz MA: TP53 codon 72 single nucleotide polymorphism (SNP) in gemcitabine (gem)/cisplatin (cis)-treated non-small-cell lung cancer (NSCLC) patients (p). J Clin Oncol; 2004 Jul 15;22(14_suppl):7161

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] TP53 codon 72 single nucleotide polymorphism (SNP) in gemcitabine (gem)/cisplatin (cis)-treated non-small-cell lung cancer (NSCLC) patients (p).
  • We hypothesized that CC homozyogtes and C-carriers (heterozygotes) could have better response and survival Methods: 202 stage IV NSCLC p were included from August 2001 to July 2002.
  • Overall: response rate (RR) 38.6%; time to progression (TTP) 6 months (m); median survival (MS) 10.56 m.
  • For p with extrapulmonary metastases, those with PS 0 had a lower risk of progression than those with PS 1 (hazard ratio = 0.4; P=0.006); TTP 8.7 m vs 4.4 m (P=0.007).
  • Such differences were not found for p with pulmonary metastases Conclusions: Although TP53 72 SNP was an attractive candidate marker for chemotherapy outcome, our results provide little support for this hypothesis.
  • Intriguingly, among p with good PS, those with extrapulmonary metastases and PS 0 had significantly better outcome than those with PS 1.

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  • (PMID = 28014212.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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18. Rosell R, Ramirez JL, Sanchez-Ronco M, Isla D, Moran T, Cobo M, Massuti B, Taron M, Carbone D, De Aguirre I: Blood-based CHRNA3 single nucleotide polymorphisms (SNPs) and outcome in advanced non-small cell lung cancer (NSCLC) patients (p). J Clin Oncol; 2009 May 20;27(15_suppl):8033

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Blood-based CHRNA3 single nucleotide polymorphisms (SNPs) and outcome in advanced non-small cell lung cancer (NSCLC) patients (p).
  • : 8033 Background: Nicotonic acetylcholine receptors (nAChRs) are associated with resistance to gemcitabine (gem), cisplatin (cis) and paclitaxel in NSCLC cell lines.
  • Three SNPs of CHRNA3, CHRNA5 and LOC123688 increase lung cancer risk.
  • These SNPs may have influenced outcome in p treated in our phase III trial (Cobo et al.
  • METHODS: Stage IV NSCLC p were treated with customized chemotherapy based on ERCC1 mRNA expression. p in the control arm received docetaxel (doc)/cis; p in the genotypic arm with low ERCC1 levels (low genotypic group [LG]) received doc/cis; p in the genotypic arm with high ERCC1 levels (high genotypic group [HG]) received doc/gem.
  • In p with PS 0, CT p had a better response than both CC (P = 0.01) and TT (P = 0.02) p, and LG p also had a better response (P = 0.01).
  • When the CHRNA3 genotype was added in the multivariate analysis for progression-free survival (PFS), an improvement was observed in the LG in PS 0 p (P = 0.02).
  • PS 0 p in the LG with the CT genotype attained an 84% response, 12.1-month PFS, and 19-month median survival (MS) ( Table ).
  • CONCLUSIONS: CHRNA3 genotyping can improve customized chemotherapy based on tumor ERCC1 mRNA in stage IV NSCLC p with PS 0.

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  • (PMID = 27962835.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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19. Sircar T, Chaudhri S, Francis A: Effect of neoadjuvant chemotherapy on oestrogen, progesterone, and HER-2 receptor expression in breast cancer. J Clin Oncol; 2009 May 20;27(15_suppl):e11588

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Effect of neoadjuvant chemotherapy on oestrogen, progesterone, and HER-2 receptor expression in breast cancer.
  • : e11588 Background: Neoadjuvant chemotherapy(NC) is used in treating locally advanced operable breast cancer.
  • After surgery, further adjuvant treatment is offered based on the estrogen receptor (ER), progesterone receptor (PR) and HER2 status.
  • Treatment post operatively can be based on the ER/PR/HER2 status of the core biopsy taken preoperatively.
  • However a change in ER/PR or HER2 status following NC could have a profound effect on adjuvant treatment with the real possibility of appropriate therapy being unknowingly withheld.
  • The aim of our study was to determine the percentage of patients whose ER/PR, HER2 receptor expression change with NC and if these changes lead to change in their adjuvant treatment.
  • METHODS: This is a retrospective study of 32 patients with locally advanced breast cancer who had NC followed by breast conservation surgery or mastectomy.
  • Quick score (Q score) for ER/PR and the HER2 expression was measured both from the preoperative core biopsy and from the excision specimen following NC.
  • RESULTS: After NC, 5 patients had complete pathological response and 2 patients had residual ductal carcinoma in situ.
  • 25(78%) patients had residual invasive malignancy.
  • Quantitative change in Q scores for ER and PR was seen in 6 patients(24%) and 10 patients (40%) respectively.
  • PR status changed from positive to negative in 4 patients(16%) and from negative to positive in one patient (4%).
  • CONCLUSIONS: Change in 1 patient(4%) from HER2 negative to HER2 positive lead to change in adjuvant treatment who would have otherwise not received transzutumab.Q scores changed in 24% and 40% for ER and PR respectively, however, no change was observed with regards to hormonal adjuvant treatment.
  • A study with a bigger cohort might address this issue.
  • We suggest that ER/PR/HER2 status should routinely be checked in both core biopsy sample and also resection specimen.

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  • (PMID = 27964117.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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20. Muehlenbein CE, Klein RW, Liepa AM, Babineaux SM, Wielage RC, Schwartzberg LS: The importance of histology when evaluating the cost-effectiveness of pemetrexed plus cisplatin as first-line therapy for advanced non-small cell lung cancer. J Clin Oncol; 2009 May 20;27(15_suppl):e17533

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] The importance of histology when evaluating the cost-effectiveness of pemetrexed plus cisplatin as first-line therapy for advanced non-small cell lung cancer.
  • : e17533 Background: A recent randomized phase III study was the first to report survival differences between first-line platinum doublets based on non-small cell lung cancer (NSCLC) histology (Scagliotti et al, J Clin Oncol. 2008).
  • Here, we estimate the cost-effectiveness of cisplatin/pemetrexed (Cis/Pem) compared to other common regimens in an overall NSCLC population and in histology subgroups.
  • METHODS: A semi-Markov model was developed to compare the two-year impact of Cis/Pem to cisplatin/gemcitabine (Cis/Gem), carboplatin/paclitaxel (Carb/Pac) and carboplatin/paclitaxel/bevacizumab (Carb/Pac/Bev) from the US payer perspective.
  • Data from the randomized controlled clinical trial and a mixed treatment comparison model (Vansteenkiste et al, Proc.
  • ITOC 2008) provided clinical inputs.
  • Medicare reimbursement rates were used to determine drug costs.
  • A retrospective claims database analysis was used to obtain estimates of other direct NSCLC-related costs, including drug administration and toxicity management.
  • Nonsquamous histology subgroups explored were adenocarcinoma, large cell and not otherwise specified (NOS).
  • RESULTS: In all patients regardless of histology, using Cis/Pem led to an incremental cost per life-year gained (LYG) of $104,577 vs. Cis/Gem and $231,291 vs. Carb/Pac.
  • In the subset of patients with nonsquamous NSCLC (adenocarcinoma, large cell, or NOS), the incremental cost per LYG was $83,537 vs. Cis/Gem and $178,613 vs. Carb/Pac.
  • Further specifying the population to include only those with adenocarcinoma or large cell NSCLC yielded an incremental cost per LYG of $72,325 vs. Cis/Gem and $132,547 vs. Carb/Pac.
  • The incremental cost per LYG for Carb/Pac/Bev vs. Cis/Pem was more than $300,000.
  • CONCLUSIONS: In an unselected advanced NSCLC population, Cis/Pem may not be considered cost-effective for first-line therapy; however, in its licensed indication of nonsquamous NSCLC, it can be considered cost-effective and even more so for patients with adenocarcinoma or large cell carcinoma.
  • This analysis emphasizes the importance of histology in identifying the appropriate patient for Cis/Pem first-line chemotherapy.

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  • (PMID = 27963793.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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21. Driesen P, Verbeke L, Lonchay C, Lambrechts M, Mentens Y, Carestia L, Rosier J, Colinet B, Chouaki N, Kraaij KJ: Phase II study of induction chemotherapy with cisplatin (Cis) and gemcitabine (Gem) followed by concomitant Cis-Gem and thoracic radiation (RTX) for unresectable locally advanced non-small cell lung cancer (LA-NSCLC). J Clin Oncol; 2009 May 20;27(15_suppl):7550

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Phase II study of induction chemotherapy with cisplatin (Cis) and gemcitabine (Gem) followed by concomitant Cis-Gem and thoracic radiation (RTX) for unresectable locally advanced non-small cell lung cancer (LA-NSCLC).
  • : 7550 Background: In the CALGB Study Cis with Gem followed by concomitant chemoradiation for inoperable LA-NSCLC was effective, however with significant toxicity (E.
  • The aim of this study was to improve tolerability by reducing the Gem dose during radiotherapy and adding one cycle of induction chemotherapy.
  • METHODS: Patients with histological proven stage IIIA and IIIB NSCLC were included in this study from 8/04 to 9/07.
  • All patients were to receive 3 induction cycles (21 days) of Cis 80 mg/m2 d1 plus Gem 1250 mg/m2 over 30 minutes d1, 8.
  • After a 3 weeks rest period, 2 cycles of concomitant chemoradiation Cis 80 mg/m2 d1, Gem 300 mg/m2 d1, 8 and RTX (about 60 Gy; 5 times 1,8 Gy fractions / week) were given.
  • Disease stage IIIA/IIIB: 28.6% / 71.4%.
  • Median dose intensity during chemoradiation Gem 98.4%, Cis 99.0% and radiation median total dose was 63 Gy.
  • Number of grade 3/4 toxicities during induction chemotherapy (N=49): neutropenia 9/9, thrombocytopenia 4/1.
  • Tumor Response Rate of enrolled patients was 22 (44.9%) (95% CI: 30.7-59.8).
  • CONCLUSIONS: Concurrent Cis Gem chemoradiation after Cis Gem induction is an active treatment for LA-NSCLC with managable toxicity.

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  • (PMID = 27963315.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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22. Biswas G, Kurkure P, Banavali S, Achrekar S, Kulkarni P, Bhagwat R, Sharma L: Challenges in management of advanced neuroblastoma: Experience at Tata Memorial Hospital, Mumbai, India. J Clin Oncol; 2004 Jul 15;22(14_suppl):8562

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • : 8562 Background: Poor therapeutic response in advanced neuroblastoma prompted us to implement St. Jude's Protocol [NB - 84, TMH NB-2] since 1987 and Ifosfamide based chemotherapy [ICE, TMH NB-3] since 1996 with the aim to improve survival rate with manageable toxicities.
  • An asymptomatic abdominal mass (62%) as a commonest presenting symptom & primary site (62.1%).
  • Stage III(17), IV(1) received 6 # of adriamycin & cyclophosphamide or 1 -2 # of adriamycin, cyclophosphamide, Cisplatin & Etoposide.
  • Surgery considered after 3/6 # or 1/2# of chemotherapy respectively.
  • Commonest presenting symptom as fever (51%) & primary site as abdomen (66.7%).
  • Stage IIB(3),III(30), IV(60) received 1cycle of TMH NB-2 as induction followed by either 2# of TMH NB-2 or 4 # TMH NB-3 as consolidation.
  • Radiotherapy or 131I MIBG treatment was given where surgery not feasible or in R1 resection.
  • ABMT was offered for gross residual disease when economically feasible & 13 Cis Retinoic acid for minimal residual disease in stage IV.
  • RESULTS: Infantile group 62% constituted intermediate risk (stage III, IV).
  • Overall response (CR+VGPR+PR) to therapy was 97%. OS is 75.06%.
  • 58% are alive & disease free at a median follow-up of 42.9 months.
  • In children>1year 94% constituted high risk (IIB, III, IV).74% showed response to therapy.
  • OS is 54.31%. 18.6 % are alive & disease free at a median follow up of 14.9 months.
  • Proper risk stratification has not been possible at our center & remains the main constraint in tailoring therapy.
  • Innovative & aggressive treatment strategies to improve survival & response rates now remains a need of time.

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  • (PMID = 28013871.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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23. Levine MA, Saunders JR, Zinreich E, Kunar D, Price J, Hirata RM, Williams M: Concurrent chemoradiation therapy for advanced head and neck squamous cell carcinoma (HNSCC) in a community hospital. J Clin Oncol; 2004 Jul 15;22(14_suppl):5558

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Concurrent chemoradiation therapy for advanced head and neck squamous cell carcinoma (HNSCC) in a community hospital.
  • : 5558 Background: Concurrent chemotherapy and radiation therapy have made organ preservation feasible in patients with advanced head and neck squamous cell carcinoma.
  • This study evaluates the use of chemotherapy with hyperfractionated radiation therapy in a community hospital and the importance of elective lymph node dissection for N2 and N3 patients.
  • METHODS: Forty-six patients with HNSCC stage III and IV (42/46 male, 35/46 oropharynx, 4 hypopharynx, 7 larynx, 25 N0-1, 21 N2-3) were treated.
  • Hyperfractionated radiation therapy was administered twice daily with an interval of at least six hours and a total dose of 7000cGy to the primary site and 5-6000cGy to the adjacent lymph node bearing areas.
  • Chemotherapy was administered during weeks 1 and 6 of radiation therapy and consisted of cis-platin 12mg/M2 IVPB days 1-5 and 5-fluorouracil 600mg/M2 continuous IV infusion over 20 hours days 1-5.
  • Twenty of twenty-one patients with N2-3 disease underwent neck dissection 6-8 weeks following completion of XRT.
  • RESULTS: Complete response (CR) at the primary site following chemo-XRT occurred in 45/46 (98%).
  • Two pts died in remission from intercurrent illnesses more than 11 months after completion of therapy.
  • Of the remaining 44 pts, 38 remain NED (86%) (3 pts died from recurrent disease, 2 pts recurred locally and were salvaged surgically, one is alive with metastatic disease).
  • TOXICITY: short term, all pts developed confluent mucositis but hospitalization for dehydration or infection was rare; long term, mouth dryness was common but manageable and most pts were PEG independent within three months of completion of therapy.
  • CONCLUSIONS: Aggressive chemo-XRT is feasible in a community hospital and affords advanced HNSCC pts the opportunity for organ preservation.
  • Pts with N2 or N3 disease should undergo neck dissection following chemo-XRT since thirty percent of these pts will have node metastases.

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  • (PMID = 28013960.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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24. Shehadeh NJ, Becker M, Yoo G, Lin HS, Jacobs J, Mathog R, Kucuk O, Kim H, Black C, Ensley J: Unknown head and neck primary: Treatment with neck dissection followed by concurrent chemoradiotherapy. J Clin Oncol; 2004 Jul 15;22(14_suppl):5530

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Unknown head and neck primary: Treatment with neck dissection followed by concurrent chemoradiotherapy.
  • Our objective was to review the outcome in a specific cohort of patients treated uniformly with modified neck dissection followed by concurrent chemoradiation.
  • METHODS: We conducted a retrospective evaluation of patients (pts) treated between 1995 and 2002 who had resectable nodal squamous cell cancer (SCC) of unknown primary sites and were treated with modified neck dissection followed by concurrent high-dose cisplatin (CIS) and radiotherapy (RT) using a port inclusive of the nasopharynx.
  • RESULTS: Thirty-six pts were identified (median age of 57; male to female ratio 3:1; African American to White ratio 1: 3; stage distribution: N1 (8%), N2a (20%), N2b (36%), N2c (8%), N3 (16%), unknown (11%); at least 60% of pts had locally advanced disease (>N2b).
  • Chemotherapy was given as cisplatin 100mg/m<sup>2</sup> x 3 cycles in 86% or CIS=>carboplatin in 14 %.
  • Therapy was not completed in 14% of pts.
  • With median follow-up of 30 months (range 7-101 months), 88 % of pts were disease-free and 12 % failed treatment: loco-regional failure (3%), loco-regional and distant metastasis (3%), and distant metastasis (6%).
  • A second primary (tongue cancer) was seen in one patient and another patient developed colon cancer at 90 months and 18 months, respectively.
  • Among the 36 pts: 86 % were alive with no evidence of disease, 6% were alive with disease and 8% died.
  • CONCLUSIONS: Neck dissection followed by chemo/RT, using high dose CIS concurrently with nasopharyngeal port RT, is an effective way of treating pts with SCC of neck from an unknown primary.
  • This treatment may confer an improved survival and warrants further prospective testing.

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  • (PMID = 28013947.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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25. Konner JA, Grabon D, Pezzulli S, Iasonos A, Sabbatini P, Hensley M, Bell-McGuinn K, Tew W, Spriggs D, Aghajanian C: A phase II study of intravenous (IV) and intraperitoneal (IP) paclitaxel, IP cisplatin, and IV bevacizumab as first-line chemotherapy for optimal stage II or III ovarian, primary peritoneal, and fallopian tube cancer. J Clin Oncol; 2009 May 20;27(15_suppl):5539

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] A phase II study of intravenous (IV) and intraperitoneal (IP) paclitaxel, IP cisplatin, and IV bevacizumab as first-line chemotherapy for optimal stage II or III ovarian, primary peritoneal, and fallopian tube cancer.
  • : 5539 Background: IP cisplatin (Cis) plus IV/IP paclitaxel (Tax) is a standard therapy for optimally debulked ovarian cancer.
  • Activity of Bev in recurrent ovarian cancer has been reported in phase II trials.
  • In this study IP Cis and IV/IP Tax are combined with IV Bev as front-line therapy.
  • METHODS: Patients with optimal (<1 cm residual), FIGO stage II or III, epithelial ovarian, fallopian tube, or peritoneal cancer, acceptable organ function, and KPS ≥ 70% are eligible.
  • Patients receive 6 cycles of chemotherapy plus Bev: Tax 135 mg/m<sup>2</sup> IV over 3 hours on Day 1, Cis 75 mg/m<sup>2</sup> IP on Day 2, Tax 60 mg/m<sup>2</sup> IP on Day 8, Bev 15 mg/kg IV on Day 1 (starting cycle 2).
  • Bev is continued every 3 weeks for 17 treatments after chemotherapy is complete.
  • The primary endpoint is safety and tolerability, determined by whether at least 60% of patients complete the prescribed 6 cycles of cytotoxic chemotherapy without unacceptable toxicity.
  • RESULTS: Thirty-nine women [median age 56 (40-69)] have been treated on study: 26 (67%) completed 6 IV/IP cycles; 5 (13%) are receiving ongoing IV/IP treatment; 4 (10%) experienced IP port malfunction (3 finished 5 IV/IP cycles, 1 came off study for port revision); 3 (8%) switched from IP Cis to IV carboplatin due to grade 3 nephrotoxicity in cycle 1 (n = 2) or grade 3 hypertension in cycle 6 (n = 1); and 1 (2.5%) patient died following rectosigmoid anastomotic dehiscence during cycle 4.
  • Grade 3/4 treatment-related toxicities include hypertension (10%), vasovagal events (10%), neutropenia (26%), nausea/vomiting (10%), and hypomagnesemia (8%).

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  • (PMID = 27962485.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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26. Riechelmann R, Sasse E, Borghesi G, Miranda V, Fede A, Saad L, Oliveira V, Barros E, Campos MP, Del Giglio A, Saad ED: Randomized phase II trials (RP2T): Selection design or poor man's phase III? J Clin Oncol; 2009 May 20;27(15_suppl):6595

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • RP2Ts are typically underpowered for statistical comparisons of endpoints between treatment arms.
  • METHODS: We systematically searched PubMed for RP2Ts on systemic cancer therapy, using the medical subject headings "drug therapy" and "neoplasms," and limiting the search to years 1995/1996 and 2005/2006, and to publication type "randomized controlled trials."
  • For each study, relevant data that were collected independently by two investigators included reporting of P values and confidence intervals (CIs) for primary (PE) and other endpoint(s) results.
  • For the PE, P values were reported in 50 (47%), and CIs in 69 (65%) RP2Ts.
  • Either P values or CIs for the PE were reported in 85 (79.4%; 95% CI: 70.8% - 86.1%) cases.
  • Likewise, source of funding and use of a control group were not associated with reporting P values/CIs for PE.

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  • (PMID = 27963894.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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27. Dipaola RS, Manola J, Li S, Vaughn D, Roth B, Wilding G: A randomized phase II trial of mitoxantrone, estramustine and vinorelbine or 13-cis retinoic acid, interferon and paclitaxel in patients with metastatic hormone refractory prostate cancer: results of ECOG 3899. J Clin Oncol; 2004 Jul 15;22(14_suppl):4594

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] A randomized phase II trial of mitoxantrone, estramustine and vinorelbine or 13-cis retinoic acid, interferon and paclitaxel in patients with metastatic hormone refractory prostate cancer: results of ECOG 3899.
  • : 4594 Background: Additional options of chemotherapy are limited for hormone refractory prostate cancer (HRPC), making the study of novel agents and combinations critical.
  • Given data demonstrating that retinoids and interferon reduce Bcl-2 expression, the effect of therapy on Bcl-2 was tested in peripheral blood mononuclear cells (PBMC).
  • METHODS: Patients (pts) received 10 mg/m2 mitoxantrone on d2, 280 mg bid estramustine on d1-5 and 25 mg/m2 vinorelbine on d2 and 9 (MEN) q3 wks (Arm A), or 1 mg/kg 13 cis-retinoic acid, 6 million U/m2 alpha interferon on d1 and 2, and 75 mg/m2 paclitaxel on d2 (RIT) weekly for 6 out of 8 weeks (Arm B).
  • RESULTS: Seventy pts with HRPC, without prior chemotherapy, were entered.
  • Partial tumor response was documented in 2/10 pts in arm A and 2/12 pts in B with measurable disease.
  • Stable measurable disease occurred in 5/10 and 6/12 pts in arm A and B respectively.
  • Bcl-2 expression in PBMCs deceased significantly during therapy only in arm B (p=0.03).
  • Therapy with MEN offers an active non-taxane combination that may warrant further study in pts after progression on taxane therapy.

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  • (PMID = 28015980.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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28. Isbarn H, Sonpavde G, Shariat SF, Palapattu GS, Sagalowsky AI, Lotan Y, Schoenberg MP, Amiel GE, Lerner SP, Karakiewicz PI: Residual pathologic stage at radical cystectomy and risk stratification of patients with pT2N0 bladder cancer. J Clin Oncol; 2009 May 20;27(15_suppl):5076

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Residual pathologic stage at radical cystectomy and risk stratification of patients with pT2N0 bladder cancer.
  • : 5076 Background: We hypothesized that in patients with pT2N0 transitional cell carcinoma (TCC) of the urinary bladder, residual muscle-invasive disease at radical cystectomy (RC) may confer poorer outcomes than residual non-muscle invasive disease due to larger tumor volume and/or biologically more aggressive disease.
  • Patients with high-risk pT2N0 disease may be candidates for trials of adjuvant therapy.
  • METHODS: Patients from the BCRC database with pT2N0 stage (N = 208) at TUR (transurethral resection) whose tumors were organ-confined at RC (≤pT2N0) were analyzed.
  • T1N0 patients (N=33) with pT2 disease at RC were also examined in order to include all pT2 patients.
  • None of the patients had received perioperative chemotherapy.
  • The effect of residual pT-stage at RC on outcomes was evaluated in Kaplan-Meier, as well as in univariable and multivariable Cox-regression models.
  • Covariates consisted of age, gender, grade, lymphovascular invasion, concomitant carcinoma-in-situ (CIS), number of lymph nodes removed, and the year of surgery.
  • RESULTS: Among baseline T2N0 patients, residual pT-stage at RC was pT0 in 24 (11.5%), pTa in 9 (4.3%), pCIS in 22 (10.6%), pT1 in 35 (16.8%), and pT2 in 118 patients (56.7%).
  • The 5-year cancer-specific survival rates for the same patient cohorts were 100%, 93%, and 81%, respectively.
  • In multivariable analyses, the effect of residual stage <pT2 at RC achieved independent predictor status for recurrence (adjusted HR 0.20; p = 0.002), as well as for cancer-specific survival (adjusted HR: 0.24; p = 0.02).
  • CONCLUSIONS: Patients with pT2N0 TCC of the urinary bladder with residual non-muscle invasive disease at RC have significantly better long-term outcomes compared to residual muscle-invasive disease.
  • With further validation, these data may facilitate the risk-stratification of patients with pT2N0 disease and enable the selection of high-risk patients for trials of adjuvant therapy.

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  • (PMID = 27964272.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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29. Chung P, Gospodarowicz M, Warde P, Qi-Long Y, Jewett M, Milosevic M, Bristow R, Moore M, Tannock I, McLean M: Long-term effects of conservation therapy for muscle invasive bladder carcinoma. J Clin Oncol; 2004 Jul 15;22(14_suppl):4519

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Long-term effects of conservation therapy for muscle invasive bladder carcinoma.
  • : 4519 Background: A review of outcomes of radiotherapy-based bladder conserving therapy in patients with muscle invasive bladder cancer was performed to assess the long term outcomes.
  • METHODS: Of 131 patients with T2/T3aN0M0 (TNM 1992) transitional carcinoma of the bladder managed at Princess Margaret Hospital between 1986 and 1997, 108 were treated with radiotherapy alone, 20 with radiotherapy plus concurrent cisplatin and 3 with neoadjuvant chemotherapy plus radiotherapy.
  • Response was assessed with cystoscopy 6 weeks after completion of treatment.
  • Overall survival (OS), cause specific survival (CSS) and local relapse free rates (LRFR) at 5 years were 44%, 58% and 49% respectively.
  • Of 47 patients with recurrent disease, 31 relapsed in the bladder only, 3 in bladder and pelvis, 2 in bladder and metastases, and 10 with metastases only.
  • Salvage treatment for those with bladder only relapse (n=31) consisted of TUR/intravesical BCG in 52% (n=16) and cystectomy in 31% (n=11).
  • Prognostic factors for improved CSS and LRFR included absence of CIS, small primary tumor (≤2cm); patients who received chemotherapy had improved CSS.
  • Only 19 of 131 pts had cystectomy for failure of local control.
  • CONCLUSIONS: RT based treatment of locally advanced bladder cancer results in bladder preservation in the majority of patients with T2-T3a N0M0 (TNM 1992) bladder cancer.
  • For select patients bladder conservation therapy with multimodality approach is an alternative to radical cystectomy.

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  • (PMID = 28016029.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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30. Shamseddine A, Seoud M, Abbas J, Charafeddine M, Salem Z, Geara F, Bikhazi K, Khalifeh M, Sidani M, El-Saghir N: Clinical characteristics and long-term survival of early breast cancer cases in the American University of Beirut Medical Center, Beirut, Lebanon. J Clin Oncol; 2004 Jul 15;22(14_suppl):833

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Clinical characteristics and long-term survival of early breast cancer cases in the American University of Beirut Medical Center, Beirut, Lebanon.
  • : 833 Background: Based on our earlier reports of increased incidence of breast cancer in younger aged-groups at presentation, we decided to review the clinical characteristics, treatment patterns and survival data of our patients (pts) with breast cancer.
  • PATIENTS AND METHODS: Retrospective review of the medical records of all pts with breast cancer treated at our institution from 1990 to 2001.
  • Patient demographics, clinical characteristics, pathology, staging, and treatment of 1328 pts were reviewed.
  • 43.9% were premenopausal (pre-m), and 56.1% postmenopausal (post-m).
  • Mean age at diagnosis was 50.8± 12 years.
  • We had 1006 patients with early stages (In-situ, 69pts, stage I: 190 and stage II: 747 pts).
  • 249 pts stage III and 73 pts stage IV at presentation.
  • 1259 pts (94.8%) had infiltrative breast cancer while in-situ disease was present in only 69 pts (4.2%) Stage I pts: Total number was 190 ps.
  • 49.5% (80 pts) of them were pre-m and 50.5% (96 pts) post-m.
  • Mean age at diagnosis is 51.1±11.8 .57% had breast-conserving surgery and 41.3% had mastectomy.
  • 71% had positive hormonal receptors (ER+/PR+: 47.8%, ER+/PR-16.7%, ER-/PR+ 6.5%) and 29% had negative receptors.
  • Adjuvant chemotherapy was given to 35.4% of pts.
  • Survival analysis showed 97.2% are still alive at 10 years.. Stage II pts: Total number 747 pts.
  • 295 (43.9%) were pre-m and 381 (56.4%) post-m.
  • Mean age at diagnosis was 50.7±12.4.
  • 66% had positive hormonal receptors (ER+/PR+: 43.9%, ER+/PR-15.2%, ER-/PR+ 6.9%) and 34% had negative receptors.
  • 68.3% had adjuvant chemotherapy.
  • More than two-thirds of our pts with early disease had positive hormonal receptors.
  • Survival is excellent at 97% at 10 years for stage I pts and good at 63.1% for stage II pts.

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  • (PMID = 28014242.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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31. Arafat WO, Rein D, Buchsbaum D, Curiel D, Zhu Z: Survivin as a novel radiation/CIS platinum/tumor specific promoter for conditional oncolytic viral therapy. J Clin Oncol; 2004 Jul 15;22(14_suppl):1535

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Survivin as a novel radiation/CIS platinum/tumor specific promoter for conditional oncolytic viral therapy.
  • : 1535 Background: Conditional oncolytic viral therapy (CRVT) is a novel approach in treatment of cancer.
  • It implies using viral genetic modification to exploit the powerful oncolytic potency of competent virus strictly in tumor.
  • Using recombinant adenovirus (Ad) with tissue specific promoter (TSP) as a vector, different clinical trial has utilized CRVT concept.
  • Although most of these trials employed CRVT in combination with radio or chemotherapy, none of the vector delivered was originally designed for combination treatment.
  • We hypothesize that; radiotherapy (RT)and/or chemotherapy may enhance the selectivity and level of induction of TSP leading to a powerful CRVT system Methods: We have constructing eligible radiation or cis platinum inducible promoter in context of Ad. including Survivin.
  • Glioma cell lines, cervical cancer as well as prostate cancer cell lines were infected with different MOI of the TSP Ad or CMV Ad then cells were exposed to a RTor to cis platinum.
  • RT increase the expression of gene expression by Cells treated with RT and Ad Luc driven by Survivin promoter up to 5-fold increase in expression after 2 Gy of RT in compare to non-irradiated cells.
  • Cis-platinum treatment shown similar trend in primary cancer cervix cell.
  • Replicative Ad driven by survivin promoter showed a significant enhancing oncolytic effect after treatment with RT in glioma cell lines.
  • CONCLUSIONS: Replicative Ad vector employing survivin promoter is a promising tool that could lead to the enhancement of selectivity and specificity of CRVT in radiogenetic and chemotherapy context No significant financial relationships to disclose.

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  • (PMID = 28015408.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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32. De Vos FY, Hoekstra R, Eskens FA, De Vries EG, Van der Gaast A, Groen HJ, Knight R, Humerickhouse RA, Gietema JA, Verweij J: Dose-finding and pharmacokinetic study of ABT-510 with gemcitabine and cisplatin in patients with advanced cancer. J Clin Oncol; 2004 Jul 15;22(14_suppl):3077

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Dose-finding and pharmacokinetic study of ABT-510 with gemcitabine and cisplatin in patients with advanced cancer.
  • ABT-510, a thrombospondin-mimetic peptide that exhibits anti-angiogenic and tumor growth inhibition in preclinical models.
  • In a single-agent phase I study twice daily (BID) subcutaneous (s.c.) showed good tolerability and exceeded the target concentration of 100 ng/mL over 3 h a day (De Vos et al, Eur. J.
  • Cancer, 2002; 38 S7: 78).
  • In an extension study, ABT-510 was combined with gemcitabine-cisplatin chemotherapy to determine safety profile, pharmacokinetics (PK) and potential drug-interaction.
  • METHODS: Patients (pts) with advanced solid tumor received gemcitabine (Gem) 1250 mg/m2 on days 1 and 8 and cisplatin (Cis) 80 mg/m2 on day 1 q 3 weeks iv along with 50 or 100 mg BID ABT-510 sc starting on day 2.
  • Plasma samples for PK were obtained on days 1 (Gem, Cis), 15 (ABT-510) and 22 (Gem, Cis, ABT-510).
  • The samples were analyzed by LC/MS/MS (ABT-510), HPLC (Gem) or AAS (Cis).
  • Anti-tumor activity was evaluated according to WHO criteria after every 2 cycles.
  • RESULTS: Thirteen pts were treated with 50 mg ABT-510 BID + Gem-Cis (7 pts) and 100 mg ABT-510 BID + Gem-Cis (6 pts).
  • The most commonly observed adverse events reflected the known toxicity profile induced by Gem-Cis without ABT-510.
  • One episode of hemoptysis occurred in a NSCLC patient after 15 days of combination treatment (possibly related).
  • The analysis of AUC showed no drug-interactions for Gem and its metabolite 2-difluoro-2-deoxyuridine (dFdU), total and unbound platinum (Pt) and for ABT-510 (Table).
  • CONCLUSIONS: Combining ABT-510 with Gem-Cis is feasible.

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  • (PMID = 28014760.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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33. Arafat W, Abdelghany A, Awad N: A clinical trial to study the effect of adding cis-retinoic acid during and after conventional treatment for pediatric neuroblastoma patient. J Clin Oncol; 2009 May 20;27(15_suppl):10057

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] A clinical trial to study the effect of adding cis-retinoic acid during and after conventional treatment for pediatric neuroblastoma patient.
  • : 10057 Background: Neuroblastoma is predominantly a tumor of early childhood, with two thirds of the cases presenting in children younger than 5 years.
  • Cis-retinoic acid has been used as maintenance therapy for treatment of advanced neuroblastoma after BMT.
  • Patients who received cis-retinoic acid had significantly better 3-year event-free survival than patients receiving no maintenance therapy.
  • However, there is no data available about usingcis-retinoic acid during induction phase of chemotherapy.
  • The aim of this study is to evaluate the efficacy of cis-retinoic acid when used in combination with conventional chemotherapy in pediatric patient who is newly diagnosed with locally advanced neuroblastoma.
  • METHODS: Seventeen newly diagnosed children with locally advanced neuroblastoma who is candidate to receive chemotherapy were also received cis-retinoic acid starting at a dose of 160 /m<sup>2</sup> day (day 2-15 of chemotherapy) first the 3 patients, 20% dose reduction were allowed if toxicity occurred in first cohort of patient. . Patients were giving the drugs for at least 4 cycles.
  • RT-PCR analysis of several related genes was done from tumor, sample after treatment.
  • Patients were stage III, IV (70%), II (30%).
  • Maximum tolerated dose were 130mg/m<sup>2</sup>, response was seen as CR 30%VGR 40, PR 12%, and PD 18%.
  • TOXICITY: Hypercalcemia mucositis, rash, and elevated liver enzymes were the main dose limiting effect of cis-retinoic acid.
  • Preliminary collaborative analysis showed that down regulation of N-MYC is related to response rate.
  • CONCLUSIONS: Cis-retinoic acid at dose 130mg/m<sup>2</sup> is a well tolerated drug with chemotherapy.
  • Response to treatment is better than historical control.

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  • (PMID = 27962453.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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34. Melzner W, Fink TH, Ficker JH, Sauer R, Strnad V: Phase II study of cisplatin, etoposide and concurrent radiation therapy with maintenance chemotherapy with cisplatin and gemcitabine for unresectable non-small cell lung cancer. J Clin Oncol; 2004 Jul 15;22(14_suppl):7290

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Phase II study of cisplatin, etoposide and concurrent radiation therapy with maintenance chemotherapy with cisplatin and gemcitabine for unresectable non-small cell lung cancer.
  • : 7290 Background:This phase II study has been conducted to determine the feasibility, toxicity, response rate, local control, distant metastases, and survival of concurrent chemotherapy with etoposide and cisplatin (cis) with 3D conformal radiotherapy and maintenance chemotherapy with cisplatin and gemcitabine in unresectable non-small cell lung cancer (NSCLC).
  • METHODS: From April 2001 to July 2003, 23 patients with unresectable stage III NSCLC were entered into this trial and 18 (78%) completed the treatment.
  • Radiotherapy was given to a total dose of 66.6 Gy (1.4-1.8 Gy) plus cisplatin (20 mg/m<sup>2</sup> d1-5, d29-34) with 2 cycles of cisplatin/etoposide chemotherapy (etoposide 90 mg/m<sup>2</sup> d1-3, d29-31).
  • Two patients (9%) had stage II, nine (39%) had stage IIIa, nine (39%) stage IIIb and three patients (13%) had stage IV disease.
  • RESULTS: Response rate was 64% with 2 CR and 13 PR.
  • At present with a minimum follow up of 12 months, overall survival was 69% at 1 year.
  • Actual local progression free survival and actual distant metastases-free survival was 65% and 74% at 1 year, respectively.
  • No patients died of treatment related toxicity.
  • CONCLUSIONS: Concurrent chemotherapy with cisplatin and etoposide with 3D conformal radiotherapy and maintenance chemotherapy with cisplatin and gemcitabine is a well tolerated regimen with very good efficacy.

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  • (PMID = 28013645.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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35. Recchia F, Sica G, Candeloro G, Bisegna R, Necozione S, Bonfili P, Tombolini V, Rea S: Multicenter phase II study of sequential chemotherapy, radiotherapy, and immunotherapy in locally advanced pancreatic (Pa) and biliary tree (Bt) adenocarcinoma (ADK). J Clin Oncol; 2009 May 20;27(15_suppl):3047

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Multicenter phase II study of sequential chemotherapy, radiotherapy, and immunotherapy in locally advanced pancreatic (Pa) and biliary tree (Bt) adenocarcinoma (ADK).
  • : 3047 Background: The aim of this study was to evaluate the activity and toxicity of a multistep, sequential treatment including induction chemotherapy (ICT), consolidation chemoradiotherapy (CXRT), and maintenance immunotherapy (MI) in untreated patients with locally advanced (LA), inoperable, or incompletely resected Pa and Bt ADK.
  • MI with low-dose interleukin-2 (IL-2) and 13-cis-retinoic acid (RA) was given in order to enhance the immune function, which could eradicate minimal residual disease, as previously shown (Clin Cancer Res 2001).
  • Patients who were progression-free (PF) after ICT received CXRT, 45 Gy in 25 fractions, using coplanar four-field technique, with concurrent capecitabine 850 mg/m<sup>2</sup>/day.
  • Six weeks after completion of CXRT, patients were restaged: In the absence of disease progression, they received, as an MI, IL-2, 1.8 x 10<sup>6</sup> I.U. and RA, 5 mg/kg, 5 days/week, 3 weeks/month for 1 year and thereafter until progression.
  • 15-40%), was observed, with 44.5% of patients achieving stable disease.
  • Thirty-eight patients, 27 with Pa and 11 with Bt ADK, had a clinical benefit from ICT, and were treated with CXRT.
  • CONCLUSIONS: These results support the efficacy and safety of a multistep sequential treatment with ICT, followed by CXRT, and an MI with IL-2 and RA, in patients with LA, inoperable or incompletely resected Pa and Bt ADK.

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  • (PMID = 27961974.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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36. Arrieta O Sr, Medina LA Sr, Guzmán E, Rios Trejo MA Sr, Mendoza D, Astorga Ramos A, Martinez Barrera L, Hernández Pedro N, Arechaga Ocampo E, De la Garza J: Liposomal doxorubicin and cisplatin as first-line chemotherapy in unresectable malignant pleural mesothelioma: A phase II study. J Clin Oncol; 2009 May 20;27(15_suppl):e13507

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Liposomal doxorubicin and cisplatin as first-line chemotherapy in unresectable malignant pleural mesothelioma: A phase II study.
  • : e13507 Background: Malignant pleural mesothelioma (MPM) is a poor prognosis neoplasm.
  • Its worldwide incidence is rising but until recently chemotherapy has not been shown to be effective in its treatment.
  • The combination of cisplatin and pemetrexed is the approved "standard" treatment in unresectable MPM.
  • Liposomal doxorubicin (LD) consists of pegylated phospholipid- vesicles that encapsulate doxorubicin conferring minimal capture from the reticulo-endothelial system resulting in a greater serum half- life, an enhanced liposome deposition in the tumor and a lower degree of toxicity.
  • We evaluated the combination of LD and Cisplatin (Cis) in chemonaive patients with unresectable MPM.
  • METHODS: From September 2006 to October 2008, consecutive patients with stage III / IV MPM were included to receive LD 40 mg/m<sup>2</sup> and Cis 60 mg/m<sup>2</sup> every 21 days for a maximum of 4 cycles.
  • Gamma camera images (GCI) of Tc-99m-labeled LD were acquired to evaluate LD accumulation in measurable tumor tissue.
  • RESULTS: Twenty seven patients were included, 81.5% were stage III and 18.5% were IV.
  • Median time to progression was 5.0 ± 1.1 months (CI 95%, 2.7-7.3).
  • Overall response was 45.5%, stable disease 36.4% and progression of 18.2%.
  • GCI showed good accumulation and retention (60%) of the labeled LD in tumor tissue at 4 h after the initial injection.
  • CONCLUSIONS: Cis+LD is a highly active regimen in MPM with comparable results to the most active regimens so far reported.

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  • (PMID = 27961260.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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37. Hussain SA, Stocken DD, Peake DR, Glaholm JG, Zarkar A, Wallace DM, James ND: Long-term results of a phase II study of synchronous chemo radiotherapy in muscle invasive bladder cancer. J Clin Oncol; 2004 Jul 15;22(14_suppl):4585

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Long-term results of a phase II study of synchronous chemo radiotherapy in muscle invasive bladder cancer.
  • : 4585 Background: We conducted a phase I/II study investigating synchronous chemoradiotherapy with mitomycin C and infusional 5-fluorouracil in muscle invasive bladder cancer.
  • Early dose escalation results were previously published (Hussain et al Annals of Oncology 12: 929-935, 2001).
  • METHODS: Patients with muscle invasive bladder cancer with GFR > 25ml/minute were eligible.
  • Mitomycin (12mg/m2 on day 1 only) and infusional 5-FU (500mg/m2/day) for 5 days was administered during weeks 1 and 4 of radiotherapy given to 55 Gy in 20 fractions.
  • 20/41 (49%) patients had hydronephrosis at presentation and 25/41 (62%) had T3b or T4 disease.
  • 6 patients did not undergo cystoscopic evaluation due to early metastatic spread though there was no clinical suggestion of bladder failure.
  • 16 (39%) patients remain alive with median follow-up of 50.7 (range 23.5-68.8) months - 14 of them with a functioning bladder with no reported long term treatment related bladder or bowel toxicity.
  • 5/41 patients have undergone salvage cystectomy; 2 for persistent CIS, 2 T1 and 1 muscle invasive recurrence.
  • 4 patients have received intra-vesical chemotherapy, of whom 2 remain alive with a functioning bladder.
  • Local and distant progression free rates were 82% and 86% at 12-m and 79% and 75% at 24-m.
  • CONCLUSIONS: Organ preservation using multimodality therapy is feasible and safe, even in patients with poor renal reserve, and does not compromise salvage therapies.

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  • (PMID = 28015967.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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38. Haid A, Knauer M, Köberle-Wührer R, Wenzl E: Sentinel node biopsy in breast cancer: technique and indication. Wien Klin Wochenschr; 2005 Feb;117(4):121-128

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Sentinel node biopsy in breast cancer: technique and indication.
  • : Sentinel node biopsy (SNB) has proved to be a useful and accurate procedure for lymph node staging in breast cancer and melanoma and should be standard of care in the treatment of these tumors.
  • SNB in breast cancer was accepted as a sole and reliable diagnostic method in breast cancer by the panel of distinguished experts at the 8th international conference of primary therapy of early breast cancer 2003 in St. Gallen.
  • Accepted indications are uni- and multifocal tumors smaller than 3 cm without suspicious findings in the axilla, furthermore SNB is indicated in patients with large ductal carcinoma in situ (>2 cm) and/or with assumed microinvasion.
  • Albeit SNB could be shown to be safe after preoperative chemotherapy and in multicentric breast cancer, due to lack of sufficient data it is still under discussion in these cases.
  • Expedience of this procedure in other lymph node basins, along the mammaria interna vessels or in the infra- and supraclavicular region is considered to be at an investigative stage as well.
  • Application of serial sectioning and immunohistochemistry results in a more accurate staging than routine examination.
  • Detection of additional micrometastases that are found in 10-15% leads to an upgrading from N0 to N1.
  • Broad application and refurbishment led to scientific discussion of prognostic importance of micrometastases and its relevance regarding axillary dissection and adjuvant systemic treatment.
  • Findings of ongoing large prospective randomized trials like NSABP 32, Z0010 and Z0011 of the American College of Surgeons (ACOSOG), the AMAROS-Trial of the European Organisation of Research and Treatment of Cancer (EORTC) and the ALMANAC-Trial of the British Association of Surgical Oncology (BASO) will give a conclusive answer.
  • Significant improvement in morbidity and quality of life measurements could be revealed several times in unicentric and even in multicentric studies like ALMANAC.
  • Participation in national clinical studies is recommended.

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  • (PMID = 28108807.001).
  • [ISSN] 1613-7671
  • [Journal-full-title] Wiener klinische Wochenschrift
  • [ISO-abbreviation] Wien. Klin. Wochenschr.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] Austria
  • [Keywords] NOTNLM ; Breast cancer / Indications / Sentinel node biopsy / Technique
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39. Humblet Y, Vega-Villegas E, Mesia R, Awada A, Geoffrois L, Borel C, Hitt R, Amellal N, Bessa EH, Bourhis J: Phase I study of cetuximab in combination with cisplatin or carboplatin and 5-fluorouracil (5-FU) in patients (pts) with recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN). J Clin Oncol; 2004 Jul 15;22(14_suppl):5513

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Phase I study of cetuximab in combination with cisplatin or carboplatin and 5-fluorouracil (5-FU) in patients (pts) with recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN).
  • METHODS: Main eligibility criteria: Stage III/IV recurrent and/or metastatic SCCHN not suitable for local therapy, no prior palliative chemotherapy (CT) except as part of a multimodal treatment for locally advanced SCCHN, adequate hematologic and biologic functions, and Karnofsky performance status (KPS) ≥ 70.
  • Typical grade 3/4 adverse events of 5-FU in combination with cisplatin and cetuximab (27 pts), regardless of relationship to the study medication, included neutropenia (48%), asthenia (30%), nausea/vomiting (30%), mucositis (15%), arrhythmia/myocardial infarction (15%), thrombopenia (11%), and dyspnea (11%); in the carboplatin group (25 pts), the most frequent grade 3/4 side effects were neutropenia (36%), asthenia (20%), dyspnea (12%), and thrombopenia (12%).
  • Preliminary efficacy results are available for 47 patients: 2 CR, 21 PR, 16 SD, 7 PD, 1 not assessable.
  • Overall response rate was 48.9% (95% CI: 34.6%-63.2%) disease control rate was 83.0%, (95%CI: 72.2%-93.7%).
  • CONCLUSIONS: Cetuximab can be safely combined with therapeutic doses of cis-/carboplatin plus 5-FU.

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  • (PMID = 28014176.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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40. Daniel DB, Crawford J, Kuderer NM, Dale DC, Lyman GH, Anc Study Group: Risk and mortality associated with febrile neutropenia in lung cancer patients. J Clin Oncol; 2004 Jul 15;22(14_suppl):7223

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Risk and mortality associated with febrile neutropenia in lung cancer patients.
  • : 7223 Background: Myelosuppression and its complications represent the major dose limiting toxicities of lung cancer chemotherapy.
  • METHODS: Length of stay, mortality and cost associated with febrile neutropenia (FN) were studied in 3,340 lung cancer patients experiencing 3,846 admissions to 115 academic institutions reporting to the University HealthSystem Consortium between 1995-2000.
  • Estimates of relative risk associated with each risk factor were based on the adjusted odds ratios (OR +/- 95%CIs) for mortality and LOS greater than 8 days.
  • CONCLUSIONS: Mortality in lung cancer patients hospitalized for FN is greater than for other solid tumors.
  • Increasing age, advanced disease, nutritional and functional impairments, and comorbidities along with infectious complications lead to prolonged hospitalization and increased risk of mortality.

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  • (PMID = 28013901.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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41. Schmittel AH, Sebastian M, von Weikersthal LF, Gauler T, Hortig P, Fischer JR, Link H, Binder D, Eberhardt W, Keilholz U, AIO Germany: Irinotecan plus carboplatin versus etoposide plus carboplatin in extensive disease small cell lung cancer: Results of the German randomized phase III trial. J Clin Oncol; 2009 May 20;27(15_suppl):8029

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Irinotecan plus carboplatin versus etoposide plus carboplatin in extensive disease small cell lung cancer: Results of the German randomized phase III trial.
  • : 8029 Background: Superiority of irinotecan over etoposide in combination with cis- or carboplatin was demonstrated in a Japanese and a Scandinavian phase III trial.
  • We report the final results of the German randomized phase III trial comparing etoposide/carboplatin (PE) to irinotecan/carboplatin (IP) in small cell lung cancer (SCLC) extensive disease.
  • METHODS: Chemotherapy-naïve extensive disease SCLC patients were randomly assigned to receive carboplatin AUC 5 mg × min/mL either in combination with 50 mg/m<sup>2</sup> of irinotecan on days 1, 8 and 15 (IP, Arm A) or with etoposide 140mg/m<sup>2</sup> days 1-3 (EP).
  • IP treatment was repeated every 4 weeks, EP every 3 weeks.
  • Primary endpoint was detection of progression free survival (PFS), secondary endpoints were overall survival (OS), response rate, and toxicity.

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  • (PMID = 27962840.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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42. Barata F, Parente B, Teixeira E, Costa A, Fernandes A, Pimentel FL, Carvalho L: A phase II trial of adding cetuximab to cisplatin and gemcitabine as first-line therapy in advanced non-small cell lung cancer (NSCLC). J Clin Oncol; 2009 May 20;27(15_suppl):e19043

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] A phase II trial of adding cetuximab to cisplatin and gemcitabine as first-line therapy in advanced non-small cell lung cancer (NSCLC).
  • : e19043 Background: Phase II and III studies have demonstrated that the EGFR-antibody, cetuximab (Erbitux), improves efficacy parameters when added to a platinum-based chemotherapy in the 1st-line treatment of patients with advanced NSCLC.
  • Main eligibility criteria included metastatic NSCLC of any histological subtype, ECOG PS 0/1, and measurable disease.
  • The primary endpoint was the overall response rate (ORR) during treatment, according to RECIST criteria.
  • Secondary endpoints included time to progression (TTP), overall survival, and adverse events.
  • ORRs and the corresponding 95% confidence intervals (CIs) were estimated and Kaplan-Meier curves were computed for TTP.
  • CONCLUSIONS: Adding cetuximab to cisplatin and gemcitabine demonstrated high efficacy (ORR and TTP) with acceptable toxicities in a nonselected population of patients in 1st-line treatment of NSCLC.

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  • (PMID = 27962103.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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43. Rodrigues MJ, Wassermann J, Albiges-Sauvin L, Stevens D, Brain E, Delaloge S, Mathieu M, Guillot E, Vincent-Salomon A, Cottu PH: Treatment of node-negative infra-centimetric HER2+ invasive breast carcinomas: A joint AERIO/REMAGUS study. J Clin Oncol; 2009 May 20;27(15_suppl):517

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Treatment of node-negative infra-centimetric HER2+ invasive breast carcinomas: A joint AERIO/REMAGUS study.
  • : 517 Background: Trials have shown benefit of adjuvant trastuzumab (TZM) for node-positive (N+) or supra-centrimetric HER-2+ breast carcinomas.
  • There are limited data concerning infra-centimetric HER-2+ invasive breast carcinomas (InfraHER-2).
  • METHODS: Retrospective multicenter series from 2000 to 2008 of infra-centimetric HER-2+ invasive breast carcinomas (InfraHER-2).
  • Tumors with ≥80% of ductal carcinoma in situ, multifocal and metastatic tumors were excluded.
  • 57% (n = 43) had a sentinel lymph node procedure.
  • 73% (n = 55) had a local irradiation and 36 a tumor bed boost.
  • 44% (n = 33) had chemotherapy (CT), almost all (31) were associated to TZM.
  • One patient developed myocardial infarction after A resulting in heart failure; 2 had a transient left ventricular ejection fraction decrease below 50% after TZM.
  • Decision of adjuvant CT was associated (all p < 0.05) with hormonal receptors (HR) negative status, Elston-Ellis grade (EE) 2/3 and high mitotic index (MI) while patients with HR+/low MI tumors were rarely treated (p < 0.001).
  • With a 25 months median follow-up, there was no invasive recurrence in TZM treated patients.
  • 3 of the 44 patients treated without TZM nor CT (7%) had local or metastatic recurrence including one fatal; they had initially HR- EE 2/3 T1b tumors.
  • CONCLUSIONS: In our practice, decision of TZM-based therapy for InfraHER-2 N- tumors is associated with high-risk profile.
  • Patients with N- InfraHER-2 tumors should be included in HER-2-targeted adjuvant trials.

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  • (PMID = 27960805.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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44. Hiller S, Mergenthaler HG: Paclitaxel and carboplatin in patients with metastatic or recurrent squamous cell carcinoma of the head and neck. A phase II study. J Clin Oncol; 2004 Jul 15;22(14_suppl):5579

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Paclitaxel and carboplatin in patients with metastatic or recurrent squamous cell carcinoma of the head and neck. A phase II study.
  • : 5579 Background: Paclitaxel and cis- or carboplatin have shown efficacy in metastatic or recurrent head & neck cancer when administered in two- to four-weekly cycles.
  • We assumed that a dose-dense weekly therapy with reduced single doses could show tolerability advantages while maintaining efficacy.
  • METHODS: We recruited patients with histologically proven metastatic, residual, or recurrent squamous cell carcinoma of the head or neck, who had no options for surgery or radiotherapy (RT).
  • Patients with contraindications to chemotherapy, an ECOG status >2 and a life-expectancy <12 weeks were excluded.
  • Complete or partial responders (CR, PR) or those showing no or minimal change (SD) received a second therapy cycle.
  • Tumour status was assessed after each cycle.
  • Tumour stage was T3 or T4 in 30/52 patients, N2 in 25/52, M0 in 42/52; tumour grade was G2 in 22/52 and G3 in 24/52.
  • Patients received 1 to 18 therapy courses (median: 11).
  • Both confirmed and unconfirmed response rates were 60% (confirmed: CR 2%; PR 20%; SD 38%).
  • Median time to progression in confirmed CR+PR was 309 days, median time to progression in all patients 113 days.
  • Median survival time was 195 days.
  • Its response rate and survival time are comparable to cisplatin-based inpatient therapies, its tolerability profile makes it suitable for outpatient therapy.

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  • (PMID = 28014001.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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45. Valle JW, Wasan HS, Palmer DD, Cunningham D, Anthoney DA, Maraveyas A, Hughes SK, Roughton M, Bridgewater JA: Gemcitabine with or without cisplatin in patients (pts) with advanced or metastatic biliary tract cancer (ABC): Results of a multicenter, randomized phase III trial (the UK ABC-02 trial). J Clin Oncol; 2009 May 20;27(15_suppl):4503

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Gemcitabine with or without cisplatin in patients (pts) with advanced or metastatic biliary tract cancer (ABC): Results of a multicenter, randomized phase III trial (the UK ABC-02 trial).
  • : 4503 Background: There is no established standard chemotherapy for pts with inoperable ABC.
  • We previously reported an improvement in progression-free survival (PFS) in a randomised phase II trial of 86 pts (ABC-01) using gemcitabine/cisplatin (GemCis) vs. gemcitabine (Gem) (Valle ASCO-GI 2006, abstr. 98).
  • METHODS: Consenting pts with histologically/cytologically-confirmed ABC, aged ≥18 years, ECOG performance status 0 - 2, and adequate haematological, hepatic and renal function were randomised to receive either Cis (25 mg/m<sup>2</sup>) followed by Gem (1000 mg/m<sup>2</sup> D1, 8 q21d) for 8 cycles, or Gem alone (1000 mg/m<sup>2</sup> on D1, 8, 15 q28d) for 6 cycles, stratified by extent of disease, site of primary tumour, ECOG score and centre.
  • The trial had an 80% power to detect an OS hazard ratio of 0.73.
  • We report the pre-planned combined analysis of ABC-01 and ABC-02 based on 410 pts (GemCis=206/Gem=204).
  • Patient characteristics: median age 64 yrs (range 23-85); male (47%); metastatic disease (75%), locally advanced (25%); gallbladder (36%), bile duct (59%), ampulla (5%); and ECOG 0-1 (87%), 2 (12%).
  • With a median follow-up of 6.1 months and 263 deaths, the median OS was greater with GemCis than Gem, 11.7 vs. 8.2 months (log rank p=0.002), with hazard ratio 0.68 (95%-CI 0.53, 0.86).
  • CONCLUSIONS: This is the largest ever study in ABC and demonstrates a clear survival advantage for GemCis without added clinically significant toxicity, setting a new international standard of care.

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  • (PMID = 27962689.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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46. Elsayed YA, Altscher A, Hillard B, Doyle-Lindrud S, Teller E, Goodin S, Shih WJ, Rubin EH, Dipaola RS: A phase I/II trial of 13-cis retinoic acid, alpha interferon, docetaxel, and estramustine (R.I.T.E.) for the treatment of hormone refractory prostate cancer (HRPC). J Clin Oncol; 2004 Jul 15;22(14_suppl):4707

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] A phase I/II trial of 13-cis retinoic acid, alpha interferon, docetaxel, and estramustine (R.I.T.E.) for the treatment of hormone refractory prostate cancer (HRPC).
  • : 4707 Background: Chemotherapy is limited for the treatment of HRPC secondary to the development of multiple mechanisms of resistance, such as the overexpression of Bcl-2.
  • To test the hypothesis that 13-cis retinoic acid (R) and interferon alpha (I), which have been shown to decrease the expression of Bcl-2, are capable of improving the results of standard chemotherapy with docetaxel (T) and estramustine (E), we began a phase I/II study in patients with HRPC.
  • The treatment was repeated every 21 days.
  • Each patient had peripheral blood mononuclear cells (PBMCs) obtained prior to therapy and on days 1-4 of the first cycle to assess the effect of therapy on Bcl-2 by immunoblot.
  • RESULTS: Ten patients have been enrolled in this ongoing phase I part of the study with 9-HRPC and1-Colon cancer.
  • Nine of 10 patients had progressed on prior therapy.
  • Therapy was well tolerated in this study.
  • Grade 3 hypophosphotemia transiently occurred after the first cycle of therapy in 2 patients in cohort 2 and 1 patient in cohort 3.
  • CONCLUSIONS: RITE therapy is well tolerated and active in this ongoing phase I/II study.

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  • (PMID = 28016742.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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47. Kubota K, Kunitoh H, Seto T, Shimada N, Tsuboi M, Okamoto H, Masuda N, Maruyama R, Shibuya M, Watanabe K: A randomized phase II trial of adjuvant chemotherapy with docetaxel (DOC) plus cisplatin (CIS) versus paclitaxel (PAC) plus carboplatin (CAR) in patients with completely resected non-small cell lung cancer (NSCLC): Safety and feasibility data from trial TORG 0503. J Clin Oncol; 2009 May 20;27(15_suppl):7561

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] A randomized phase II trial of adjuvant chemotherapy with docetaxel (DOC) plus cisplatin (CIS) versus paclitaxel (PAC) plus carboplatin (CAR) in patients with completely resected non-small cell lung cancer (NSCLC): Safety and feasibility data from trial TORG 0503.
  • : 7561 Background: Adjuvant chemotherapy is standard of care for patients with completely resected stage IB, II and IIIA NSCLC.
  • However, the optimum chemotherapy regimen has not been determined.
  • TORG 0503 was conducted to evaluate platinum-based third generation regimens in this clinical setting.
  • METHODS: Patients with completely resected stage IB, IIA, IIB or stage IIIA NSCLC were stratified by stage (IB/IIA vs. IIB/IIIA) and institution and randomized to receive 3 cycles of DOC (60 mg/m2, day 1) plus CIS (80 mg/m2, day 1) or 3 cycles of PAC (200 mg/m2, day 1) plus CAR (AUC 6, day 1).
  • Other eligibility criteria included ECOG PS 0-1, age ≥20, and =<70 years old, adequate organ function, no prior chemotherapy or radiotherapy.
  • RESULTS: 111 patients were randomized between April 2006 and July 2008, 58 patients to DOC+CIS (DC) and 53 to PAC+CAR (PA).
  • Patients' demographics (DC/PA): median age 63/59 years, 60%/66% male, 17%/22% PS 1, 79%/73% adenocarcinoma, 40%/40% of patients were stage IB/IIA, 60%/60% IIB/IIIA.
  • Feasibility: 93% (54/58) of patients allocated to DC and 92% (49/53) patients in the PA arm completed 3 planned cycles of chemotherapy.
  • No treatment related deaths were observed in either arm.
  • CONCLUSIONS: Both docetaxel plus cisplatin and paclitaxel plus carboplatin are safe and feasible regimens as adjuvant chemotherapy.

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  • (PMID = 27963338.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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48. Recchia F, De Filippis S, Saggio G, Cesta A, Amiconi G, Di Blasio A, Rea S: Interleukin-2 (IL-2) with 13-cis retinoic acid (RA) to prolong disease free and overall survival in metastatic colorectal cancer. J Clin Oncol; 2004 Jul 15;22(14_suppl):3629

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Interleukin-2 (IL-2) with 13-cis retinoic acid (RA) to prolong disease free and overall survival in metastatic colorectal cancer.
  • : 3629 Background: In a phase 1B study we established that low-dose IL-2 and 13-cis retinoic acid was not toxic and could be administered safely as maintenance therapy for patients (PTS) exhibiting response or disease stabilization to chemotherapy, but at a high risk of relapse (Clin Cancer Res 7: 1251-1257, 2001).
  • A phase II study (Int J Oncol 20: 1275-82, 2002) showed the efficacy of such regimen in improving immunological parameters and in prolonging response in the same category of PTS.
  • The objective of this phase II study was to verify whether the combination of IL-2 and RA could improve the outcome of PTS operated for colorectal cancer recurrence.
  • Eight PTS had synchronous metastases, while 12 had a median disease-free survival of 14 months and had received a 5-fluorouracil (5-FU) leucovorin (LV) based adjuvant chemotherapy.
  • After chemotherapy PTS received IL-2, 1.8 x 10<sup>6</sup> I.U. plus RA 0.5 mg/Kg for 5 days/week for 2 consecutive cycles of 3 weeks, with a 1-week rest, for up to 3 years.
  • PTS were monitored every 2 months by determination of vascular endothelial growth factor (VEGF), CD4/CD8 ratio, NK and tumor markers, with response assessed every 4 months.
  • With a combination of surgery and chemotherapy, a 75% response rate was obtained (95% C.I., 51%-91%).
  • After a median follow-up of 20 months, median time to progression and overall survival were not reached yet.
  • There was an improvement of all immunological parameters controlled over time (CD4/CD8, NK, decrease of VEGF).
  • CONCLUSIONS: Compared to historical controls, IL-2 and RA therapy improves the DFS and overall survival after curative resection of metastases from colorectal cancer.

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  • (PMID = 28014571.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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49. Ajani JA, Yao J, Faust J, Carr K, Anbe H, Houghton M, Urrea P: Phase I pharmacokinetic study of S-1 plus cisplatin in patients with advanced gastric carcinoma (AGC). J Clin Oncol; 2004 Jul 15;22(14_suppl):4043

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Phase I pharmacokinetic study of S-1 plus cisplatin in patients with advanced gastric carcinoma (AGC).
  • : 4043 Background: S-1 (Tegafur, Oxonic acid, & CDHP), an active oral drug against AGC, combined with Cis resulted in a >70% response rate in Japan ( Br J Cancer 89:2207, 2003).
  • METHODS: A phase I study of S-1 & Cis with pharmacokinetics (PKs) in patients (Pts) with AGC was performed to determine the MTD in the 1<sup>st</sup> cycle.
  • The starting dose of S-1 (Level 1) was 25 mg/m<sup>2</sup> bid (or 50 mg/m<sup>2</sup>/day) on d 1-21 q 28 d.
  • The dose of S-1 was increased by 5 mg/m<sup>2</sup>/dose (Level 2).
  • Cis was initially given at 75 mg/m<sup>2</sup> q 28 d (Levels 1 & 2) but was reduced to 60 mg/m<sup>2</sup> (to add Level 1A).
  • ≤2 chemotherapy regimens were allowed.
  • 4 (25%) had prior chemotherapy.
  • PKs (Cmax/AUC of tegafur, 5-FU, oxonic acid, CA & CDHP) were performed in all Pts.
  • Pts with a DLT had higher 5-FU PK parameters than those without a DLT.
  • CONCLUSIONS: Level 1 (S1/Cis at 50/75) is the MTD of this combination and DLTs correlated with PKs.

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  • (PMID = 28014361.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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50. Whitworth PW, Presant CA, Rutledge J, Hallquist A, Perree M, Agapitos D: Chemosensitivity (CS) of patient (pt) breast cancer (BrCa) cells in vitro: Correlation with prior chemotherapy (CT) and implications for personalized treatment planning. J Clin Oncol; 2009 May 20;27(15_suppl):e11563

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Chemosensitivity (CS) of patient (pt) breast cancer (BrCa) cells in vitro: Correlation with prior chemotherapy (CT) and implications for personalized treatment planning.
  • : e11563^ Background: A predictive BrCa chemosensitivity assay will facilitate individualized treatment.
  • In order to determine the in vitro CS of pt BrCa cells, we tested pt tumor cells (tc) in vitro using the MiCK assay.
  • METHODS: Tumor excisions or biopsies were sent to a central laboratory, prepared using our previously described MiCK technology (Lab Invest 74: 557, 1996) and tc apoptosis was measured over 48 hours with various drugs.
  • In vitro results were compared to clinical status.
  • CS to drugs for tc from pts with no prior CT was: paclitaxel (P) mean 1.2 KU, cyclophosphamide as 4-hydroxycyclophosphamide (4HC) 2.7, doxorubicin (Dox) 1.8, epirubicin (Epi) 2.1, docetaxel (Doc) 2.0, vinorelbine 0.9, gemcitabine (Gem) 0.7, liposomal D 1.4, carboplatin (Carbo) 1.7, cisplatin (Cis) 2.0, and topotecan 1.2.
  • Combinations tested in some pts showed Carbo-P 2.6 KU and Cis-Gem 2.7.
  • MiCK may also be useful in developing new drugs and new combination therapies.
  • For clinical trials that began accrual on or after April 29, 2004, ASCO's Policy places some restrictions on the financial relationships of principal investigators (J Clin Oncol.
  • Among the circumstances that might justify an exception are that the principal investigator (1) is a widely acknowledged expert in a particular therapeutic area;.
  • (2) is the inventor of a unique technology or treatment being evaluated in the clinical trial; or (3) is involved in international clinical oncology research and has acted consistently with recognized international standards of ethics in the conduct of clinical research.
  • Abstracts for which authors requested and have been granted an exception in accordance with ASCO's Policy are designated with a caret symbol (^) in the Annual Meeting Proceedings.

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  • (PMID = 27964068.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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51. Gronwald J, Byrski T, Huzarski T, Dent R, Bielicka V, Zuziak D, Wisniowski R, Lubinski J, Narod S: Neoadjuvant therapy with cisplatin in BRCA1-positive breast cancer patients. J Clin Oncol; 2009 May 20;27(15_suppl):502

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Neoadjuvant therapy with cisplatin in BRCA1-positive breast cancer patients.
  • : 502 Background: Neoadjuvant chemotherapy is administered to control disease, make surgical resection possible and increase the possibility of breast tissue conservation.
  • A further advantage of neoadjuvant therapy is that it helps to assess chemo-sensitivity to a particular agent.
  • Induction of a pathological complete response (pCR) is one of the primary goals of neoadjuvant therapy in order to achieve a better disease-free and overall survival.
  • Experimental data suggest that BRCA1 related breast cancer may have increased sensitivity to platinum-based chemotherapy, but clinical data are limited.
  • The aim of this study was to evaluate the frequency of complete pathologic response after neo-adjuvant treatment with cisplatin chemotherapy in women with breast cancer and a BRCA1 mutation.
  • METHODS: Twenty five women with breast cancer and a BRCA1 mutation with stage I, II, and III breast cancer between December 2006 and December 2008 were entered into this study.
  • After chemotherapy, patients underwent surgery and were assessed for pathologic response in both the breast and axillary lymph nodes.
  • Complete pathologic response was defined as no residual invasive disease in both the breast and axilla, however ductal carcinoma in situ was allowed.
  • Thirteen patients had tumors of greater than two centimeters (52%) and seven patients had positive lymph nodes at diagnosis (28%).
  • Clinical complete response was observed in eighteen patients (72%).
  • CONCLUSIONS: Platinum-based chemotherapy is effective in a high proportion of patients with BRCA1-associated breast cancers.
  • Clinical trials are warranted to determine the optimum treatment for this subgroup of breast cancer patients.

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  • (PMID = 27960785.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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52. Lee J, Min W, Kim S, Son B: Comparison of serum HER-2/neu between trastuzumab-based regimen and anthyracycline-based regimen during neoadjuvant chemotherapy in advanced primary breast cancer. J Clin Oncol; 2009 May 20;27(15_suppl):e11582

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Comparison of serum HER-2/neu between trastuzumab-based regimen and anthyracycline-based regimen during neoadjuvant chemotherapy in advanced primary breast cancer.
  • : e11582 Background: Serum Her-2/neu has been known as molecular surrogating marker of predicting treatment response in Her-2 positive breast cancer.
  • We compare the change of serum Her-2/neu during neoadjuvant chemotherapy between trastuzumab(H) and anthyracyline(A) based treatment.
  • METHODS: All breast cancers were tested by immunohistochemical stain and FISH for Her-2/neu before treatment.
  • Serum Her-2/neu was twice measured by Chemiluminescence immunoassay(ADVIA centaurTMsystem) before neoadjuvant chemotherapy and before operation.
  • Pathologic complete response (pCR) was considered as no residual tumor or remnant ductal carcinoma in situ, partial response (PR) was less than 50% decrease in maximal diameter in pathologic tumor size.
  • In trastuzumab group, pCR was relatively correlated with decrease of serum Her-2/neu (PR: 0.8 ± 0.84 ng/ml vs. pCR: 21.1 ± 13.2 ng/ml, p=0.08).
  • CONCLUSIONS: A decrease in serum Her-2/neu levels during treatment was associated with pathologic response in patients receiving neoadjuvant chemotherapy, particularly, trastuzumab-based regimen.
  • Serum Her-2/neu levels may serve to monitoring neoadjuvant therapy in Her-2/neu positive breast cancer.

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  • (PMID = 27964116.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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53. Martin LP, Kozloff MF, Krzakowski M, Samuel TA, Rado TA, Tarazi J, Rosbrook B, Tortorici M, Olszanski AJ, Cohen RB: Axitinib (AG-013736; AG) combined with chemotherapy in patients (pts) with advanced non-small cell lung cancer (NSCLC) and other solid tumors. J Clin Oncol; 2009 May 20;27(15_suppl):3559

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Axitinib (AG-013736; AG) combined with chemotherapy in patients (pts) with advanced non-small cell lung cancer (NSCLC) and other solid tumors.
  • Anti-VEGF therapies combined with chemotherapy improve survival vs chemotherapy alone in pts with advanced solid tumors, including NSCLC.
  • This phase I trial assessed AG combined with chemotherapy.
  • METHODS: Pts with advanced solid tumors without prior treatment with platins or taxanes received paclitaxel/carboplatin (P: 200 mg/m<sup>2</sup> / C: AUC 6 mg*min/mL) every 3 weeks + AG at lead-in doses of 1, 3 or 5 mg BID.
  • Another cohort of pts with any prior chemotherapy for metastatic disease received AG 5 mg BID + gemcitabine/cisplatin (G: 1250 mg/m<sup>2</sup> on days 1 and 8 / Cis: 80 mg/m<sup>2</sup> on day 1) in 3-week cycles.
  • For all cohorts, cycle 1 consisted of a 3-5-day lead-in period followed by AG for 18 days.
  • Following determination of the maximum tolerated doses (MTDs) of AG + P/C or G/Cis, pts with squamous NSCLC were enrolled into an expansion cohort (prior anti-VEGF therapy not permitted) and received AG 5 mg BID + P/C.
  • RESULTS: A total of 47 pts were enrolled; 26 pts were evaluable in the P/C cohort (including 12 pts with squamous NSCLC) and 21 pts in the G/Cis cohort.
  • The MTD for AG in combination with standard doses of P/C and G/Cis was 5 mg BID.
  • Treatment-related AEs included hypertension (42%), diarrhea (35%) and fatigue (35%) in the P/C cohort, and headache (29%), hypertension (29%) and fatigue (24%) in the G/Cis cohort.
  • The ORR was 29% and 26% for P/C (n = 24) and G/Cis (n = 19) cohorts, respectively.
  • AG, P, C, G and Cis PK parameters and profiles were similar when administered alone and in combination (eg P: mean (%CV) AUC<sub>inf</sub> 20,822 (21) and 20,596 (21) ng.h/mL, respectively).
  • CONCLUSIONS: AG 5 mg BID can be combined with standard P/C and G/Cis regimens with no apparent overlapping toxicities and unaltered PK.

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  • (PMID = 27961360.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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54. Bhide S, Gulliford S, A'Hern R, Hall E, Newbold K, Harrington K, Nutting C: Quantitative estimates of the effects of concomitant chemotherapy on acute dysphagia in patients receiving radical treatment for head and neck cancer. J Clin Oncol; 2009 May 20;27(15_suppl):e22134

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Quantitative estimates of the effects of concomitant chemotherapy on acute dysphagia in patients receiving radical treatment for head and neck cancer.
  • : e22134 Purpose: To generate quantitative parameters describing the effect of concomitant chemotherapy on incidence of grade 3 dysphagia (CTCAE v3.0, assisted feeding) using dose response curves in patients receiving radical treatment for head and neck cancer.
  • METHODS: Patients treated at a single centre in prospective phase I and II trials of concomitant chemo-IMRT (CRT) (n=85) and the phase III trial of IMRT vs. conventional radiotherapy (PARSPORT) (n=82) formed the basis of this non-randomized comparison.
  • Concomitant chemotherapy was cisplatin (100 mg/m<sup>2</sup>) on days 1 and 29.
  • The dose response curves were fitted using non-linear logistic regression.
  • Fitting dose response curves to the clinical data yielded parameter values (95% CIs) of MD<sub>50</sub>=46 Gy (42-49), k=4.8 (2.3-7.2) for the CRT group and MD<sub>50</sub>= 58 Gy (55-61), k=3 (1.6-.45) for RT group.
  • CONCLUSIONS: Addition of concomitant chemotherapy increases the incidence of G3 dysphagia by 0.65% for every 1 Gy increase in radiation dose.
  • The observed MD<sub>50</sub> for G3 dysphagia is lower for RT alone (46 Gy vs. 58 Gy).

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  • (PMID = 27963581.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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55. Winton TL, Livingston R, Johnson D, Rigas J, Cormier Y, Butts C, Ding K, Seymour L, Magoski N, Shepherd F: A prospective randomised trial of adjuvant vinorelbine (VIN) and cisplatin (CIS) in completely resected stage 1B and II non small cell lung cancer (NSCLC) Intergroup JBR.10. J Clin Oncol; 2004 Jul 15;22(14_suppl):7018

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] A prospective randomised trial of adjuvant vinorelbine (VIN) and cisplatin (CIS) in completely resected stage 1B and II non small cell lung cancer (NSCLC) Intergroup JBR.10.
  • : 7018 Background: In meta-analyses platinum based adjuvant chemotherapy using 2<sup>nd</sup> generation regimens increased cure rate by 5% in completely resected NSCLC.
  • JBR.10 was undertaken to determine whether the 3<sup>rd</sup> generation regimen VIN/CIS prolonged survival in this clinical setting.
  • METHODS: Patients with completely resected stage 1 (T2N0) or stage 2 (excluding T3N0) NSCLC were stratified by nodal status (N0 vs. N1) and ras mutation status (present vs. absent vs. unknown) and randomised to receive 4 cycles of VIN (25mg/m<sup>2</sup> weekly x 16 weeks) plus CIS (50mg/m<sup>2</sup> days 1 and 8 q 4 weeks x 4) or follow up alone; VIN dose was reduced from 30mg/m<sup>2</sup> shortly after the study started due to unacceptable toxicity.
  • The commonest non-hematologic toxicities for VIN/CIS patients were fatigue (77%), nausea (76%), anorexia (53%), vomiting (46%), sensory neuropathy (45%) and constipation (44%).
  • Two patients died of drug-related toxicity [1 febrile neutropenia, 1 pulmonary fibrosis].
  • The most common cause of death was NSCLC (including 1 patient with 2<sup>nd</sup> primary NSCLC), while 3 patients died from toxicity related to later anti-cancer therapy, 9 patients died of other primary malignancies, and 21 from other causes.
  • Overall survival was significantly prolonged for VIN/CIS patients (94 months vs. 73 months; HR 0.69, p=0.011), as was RFS (not reached vs. 46.7 months; HR 0.6, p 0.0003).
  • 5-year survival for VIN/CIS patients was 69% compared to 54% for patients followed expectantly.
  • 38 patients developed 2<sup>nd</sup> malignancies.
  • CONCLUSIONS: This is the first randomized clinical trial demonstrating that a 3<sup>rd</sup> generation platinum-based doublet prolongs OS and RFS after surgery in early stage NSCLC.

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  • (PMID = 28016266.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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56. Lemaitre RN, Psaty BM, Heckbert SR, Kronmal RA, Newman AB, Burke GL: Therapy with hydroxymethylglutaryl coenzyme a reductase inhibitors (statins) and associated risk of incident cardiovascular events in older adults: evidence from the Cardiovascular Health Study. Arch Intern Med; 2002 Jun 24;162(12):1395-400
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Therapy with hydroxymethylglutaryl coenzyme a reductase inhibitors (statins) and associated risk of incident cardiovascular events in older adults: evidence from the Cardiovascular Health Study.
  • BACKGROUND: Recommendations to treat older adults with hydroxymethylglutaryl coenzyme A reductase inhibitors (statins) for the primary prevention of coronary heart disease events are supported by a single clinical trial restricted to adults 73 years or younger with low levels of high-density lipoprotein cholesterol.
  • METHODS: We investigated the association of statin use with incident cardiovascular disease and all-cause mortality during up to 7.3 years' follow-up of 1250 women and 664 men from the Cardiovascular Health Study.
  • Study participants were 65 years and older and free of cardiovascular disease at baseline.
  • They received drug therapy to lower cholesterol levels at baseline or no treatment with a recommendation for therapy according to the National Cholesterol Education Program guidelines.
  • Use of these drugs was assessed annually.
  • We used proportional-hazards models to calculate hazard ratios (HRs) and 95% confidence intervals (CIs), adjusted for confounding variables.
  • RESULTS: We found 382 incident cardiovascular events (159 myocardial infarctions, 159 strokes, and 64 deaths due to coronary heart disease) and 362 total deaths from June 1, 1989, to May 31, 1997.
  • Compared with no use of drugs to lower cholesterol levels, statin use was associated with decreased risk of cardiovascular events (multivariate HR, 0.44; 95% CI, 0.27-0.71) and all-cause mortality (HR, 0.56; 95% CI, 0.36-0.88).
  • These findings lend support to the National Cholesterol Education Program guidelines, which recommend therapy for the lowering of cholesterol levels for older adults with hypercholesterolemia.
  • [MeSH-major] Coronary Disease / drug therapy. Coronary Disease / prevention & control. Hydroxymethylglutaryl-CoA Reductase Inhibitors / therapeutic use. Hypolipidemic Agents / therapeutic use
  • [MeSH-minor] Aged. Cholesterol, LDL / drug effects. Female. Follow-Up Studies. Humans. Hypercholesterolemia / drug therapy. Incidence. Male. Multivariate Analysis. Proportional Hazards Models. Risk Factors. United States

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  • [CommentIn] Arch Intern Med. 2002 Jun 24;162(12):1329-31 [12076230.001]
  • (PMID = 12076239.001).
  • [ISSN] 0003-9926
  • [Journal-full-title] Archives of internal medicine
  • [ISO-abbreviation] Arch. Intern. Med.
  • [Language] eng
  • [Grant] United States / NIA NIH HHS / AG / AG09556; United States / NHLBI NIH HHS / HC / N01-HC-85079; United States / NHLBI NIH HHS / HC / N01-HC-85086; United States / NHLBI NIH HHS / HC / N0C-HC-15103; United States / NHLBI NIH HHS / HC / N0C-HC-35129
  • [Publication-type] Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, P.H.S.
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Cholesterol, LDL; 0 / Hydroxymethylglutaryl-CoA Reductase Inhibitors; 0 / Hypolipidemic Agents
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57. Kahler KH, Rajan M, Rhoads GG, Safford MM, Demissie K, Lu SE, Pogach LM: Impact of oral antihyperglycemic therapy on all-cause mortality among patients with diabetes in the Veterans Health Administration. Diabetes Care; 2007 Jul;30(7):1689-93
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Impact of oral antihyperglycemic therapy on all-cause mortality among patients with diabetes in the Veterans Health Administration.
  • OBJECTIVE: The objective of this analysis was to evaluate the impact of several classes of oral antihyperglycemic therapy relative to sulfonylurea monotherapy on all-cause mortality among a cohort of patients with diabetes from the Veterans Health Administration (VHA).
  • Users of oral antihyperglycemic therapy were classified into the following cohorts: sulfonylurea monotherapy, metformin monotherapy, metformin plus sulfonylurea, thiazolidinedione (TZD) use alone or in combination with other oral agents (TZD users), and no drug therapy.
  • Multivariate mixed models incorporating a propensity score to account for imbalance among cohorts were used to estimate drug effects on mortality with associated 95% CIs.
  • Adjusted odds ratios and 95% CIs for all-cause mortality were 0.87 (0.68-1.10) for metformin monotherapy users, 0.92 (0.82-1.05) for metformin plus sulfonylurea users, and 1.04 (0.75-1.46) for TZD users, relative to sulfonylurea monotherapy users.
  • CONCLUSIONS: We did not find any significant drug effect on all-cause mortality for any oral treatment cohorts relative to sulfonylurea oral monotherapy.
  • [MeSH-major] Diabetes Mellitus, Type 2 / drug therapy. Diabetes Mellitus, Type 2 / mortality. Hypoglycemic Agents / administration & dosage
  • [MeSH-minor] Administration, Oral. Aged. Cohort Studies. Drug Therapy, Combination. Female. Hospitals, Veterans. Humans. Male. Metformin / administration & dosage. Middle Aged. Retrospective Studies. Sulfonylurea Compounds / administration & dosage. Thiazolidinediones / administration & dosage

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  • (PMID = 17440170.001).
  • [ISSN] 1935-5548
  • [Journal-full-title] Diabetes care
  • [ISO-abbreviation] Diabetes Care
  • [Language] eng
  • [Publication-type] Journal Article; Research Support, U.S. Gov't, Non-P.H.S.
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Hypoglycemic Agents; 0 / Sulfonylurea Compounds; 0 / Thiazolidinediones; 9100L32L2N / Metformin
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58. Marchetti A, Wang L, Magar R, Grossman HB, Lamm DL, Schellhammer PF, Erwin-Toth P: Management of patients with Bacilli Calmette-Guérin-refractory carcinoma in situ of the urinary bladder: cost implications of a clinical trial for valrubicin. Clin Ther; 2000 Apr;22(4):422-38
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Management of patients with Bacilli Calmette-Guérin-refractory carcinoma in situ of the urinary bladder: cost implications of a clinical trial for valrubicin.
  • OBJECTIVE: This study was undertaken to identify the expected first- and second-year clinical costs associated with intravesical valrubicin therapy, using a decision analytic model, for patients with Bacilli Calmette-Guérin (BCG)-refractory carcinoma in situ (CIS) of the urinary bladder.
  • BACKGROUND: Cancer of the urinary bladder is the fourth most common malignancy in men and the sixth most common noncutaneous carcinoma overall.
  • One histopathologic stage of bladder cancer is CIS, for which BCG intravesical immunotherapy is the first-line therapy.
  • Radical cystectomy has been recommended for patients with CIS who do not respond to or become refractory to therapy with BCG.
  • Surgery, however, may not be appropriate for all patients, especially those who are ineligible for the lengthy procedure because of advanced age or comorbidities and those who prefer alternative nonsurgical management.
  • For these groups, intravesical valrubicin therapy is a plausible alternative.
  • METHODS: Models were developed and populated with data from 1 open-label study of 90 patients, information from the medical literature, and input from clinical experts.
  • RESULTS: Our data indicate that first- and second-year expected costs for valrubicin therapy are $19,912 and $23,496, respectively.
  • Expected cost for radical cystectomy was also evaluated, since some patients may have no other option if drug therapy fails.
  • CONCLUSION: Our cost-consequence analysis and clinical data provide decision-makers with tools to aid in global budgetary projections of fractional and total expected health care costs associated with the management BCG-refractory CIS of the urinary bladder.
  • [MeSH-major] BCG Vaccine. Carcinoma in Situ / drug therapy. Carcinoma in Situ / economics. Doxorubicin / analogs & derivatives. Urinary Bladder Neoplasms / drug therapy. Urinary Bladder Neoplasms / economics

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  • (PMID = 10823364.001).
  • [ISSN] 0149-2918
  • [Journal-full-title] Clinical therapeutics
  • [ISO-abbreviation] Clin Ther
  • [Language] eng
  • [Publication-type] Clinical Trial; Journal Article; Research Support, Non-U.S. Gov't
  • [Publication-country] UNITED STATES
  • [Chemical-registry-number] 0 / BCG Vaccine; 2C6NUM6878 / valrubicin; 80168379AG / Doxorubicin
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59. Gonzales ML, Dans LF, Martinez EG: Antiamoebic drugs for treating amoebic colitis. Cochrane Database Syst Rev; 2009;(2):CD006085
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Antiamoebic drugs for treating amoebic colitis.
  • BACKGROUND: Entamoeba histolytica infection is common in developing countries, and up to 100,000 individuals with severe disease die every year.
  • Adequate therapy for amoebic colitis is necessary to reduce the severity of illness, prevent development of complicated disease and extraintestinal spread, and decrease transmission.
  • OBJECTIVES: To evaluate antiamoebic drugs for treating amoebic colitis.
  • SEARCH STRATEGY: In September 2008, we searched the Cochrane Infectious Diseases Group Specialized Register, CENTRAL (2008, Issue 3), MEDLINE, EMBASE, LILACS, mRCT, and conference proceedings.
  • SELECTION CRITERIA: Randomized controlled trials of antiamoebic drugs given alone or in combination, compared with placebo or another antiamoebic drug for treating adults and children diagnosed with amoebic colitis.
  • We calculated clinical and parasitological failure rates, relapse, and adverse events as risk ratios (RR) with 95% confidence intervals (CIs), using a random-effects model.
  • Only one trial used a E. histolytica stool antigen test.
  • Tinidazole reduced clinical failure compared with metronidazole (RR 0.28, 95% CI 0.15 to 0.51; 477 participants, eight trials) and was associated with fewer adverse events.
  • Compared with metronidazole, combination therapy resulted in fewer parasitological failures (RR 0.36, 95% CI 0.15 to 0.86; 720 participants, 3 trials).
  • AUTHORS' CONCLUSIONS: Tinidazole is more effective in reducing clinical failure compared with metronidazole and has fewer associated adverse events.
  • Combination drug therapy is more effective in reducing parasitological failure compared with metronidazole alone.
  • Further trials of the efficacy of antiamoebic drugs, with better methodological quality, are recommended.
  • [MeSH-major] Amebicides / therapeutic use. Dysentery, Amebic / drug therapy
  • [MeSH-minor] Animals. Drug Therapy, Combination. Entamoeba histolytica. Humans. Metronidazole / adverse effects. Metronidazole / therapeutic use. Randomized Controlled Trials as Topic. Tinidazole / adverse effects. Tinidazole / therapeutic use

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  • (PMID = 19370624.001).
  • [ISSN] 1469-493X
  • [Journal-full-title] The Cochrane database of systematic reviews
  • [ISO-abbreviation] Cochrane Database Syst Rev
  • [Language] eng
  • [Publication-type] Journal Article; Meta-Analysis; Review
  • [Publication-country] England
  • [Chemical-registry-number] 0 / Amebicides; 033KF7V46H / Tinidazole; 140QMO216E / Metronidazole
  • [Number-of-references] 73
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60. Grimmsmann T, Schwabe U, Himmel W: The influence of hospitalisation on drug prescription in primary care--a large-scale follow-up study. Eur J Clin Pharmacol; 2007 Aug;63(8):783-90
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] The influence of hospitalisation on drug prescription in primary care--a large-scale follow-up study.
  • OBJECTIVE: To explore the influence of hospitalisation on the prescription of drugs in the primary care sector using prescription data of a major statutory health insurance (SHI) organisation, with a special focus on the so-called "Me-Too" drugs - in particular, 3-hydroxy-3-methyl-glutaryl (HMG) CoA reductase inhibitors (statins) and proton pump inhibitors (PPIs).
  • METHODS: A comprehensive outpatient drug prescription analysis was conducted on members of a SHI who had been hospitalised during the first 3 months of 2004.
  • Data are shown in absolute and relative numbers as well as relative risks (RR) and their 95% confidence intervals (CIs).
  • Changes in medication affected nearly every patient (98.1%), and 60% had at least five changes.
  • Significantly more patients received a PPI or statin after hospitalisation (RR for a PPI: 1.27; 95% CI: 1.12 -1.45; RR for a statin: 1.16; 95% CI: 1.02-1.32).
  • The increase in PPI medication was due to a 58% increase in the number of patients receiving pantoprazole, a "Me-Too" drug.
  • CONCLUSION: Hospitalisation exerts a marked influence on drug therapy in ambulatory care, with a significant increase in the prescription of novel, on-patent drugs instead of less expensive alternatives.
  • [MeSH-major] Continuity of Patient Care. Drug Prescriptions / statistics & numerical data. Hospitalization
  • [MeSH-minor] 2-Pyridinylmethylsulfinylbenzimidazoles / administration & dosage. Atorvastatin Calcium. Databases, Factual. Drug Utilization Review / statistics & numerical data. Follow-Up Studies. Heptanoic Acids / administration & dosage. Humans. Hydroxymethylglutaryl-CoA Reductase Inhibitors / administration & dosage. Outpatients. Proton Pump Inhibitors / administration & dosage. Pyrroles / administration & dosage

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  • (PMID = 17549465.001).
  • [ISSN] 0031-6970
  • [Journal-full-title] European journal of clinical pharmacology
  • [ISO-abbreviation] Eur. J. Clin. Pharmacol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] Germany
  • [Chemical-registry-number] 0 / 2-Pyridinylmethylsulfinylbenzimidazoles; 0 / Heptanoic Acids; 0 / Hydroxymethylglutaryl-CoA Reductase Inhibitors; 0 / Proton Pump Inhibitors; 0 / Pyrroles; 48A5M73Z4Q / Atorvastatin Calcium; D8TST4O562 / pantoprazole
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61. Meigs JB, Cupples LA, Wilson PW: Parental transmission of type 2 diabetes: the Framingham Offspring Study. Diabetes; 2000 Dec;49(12):2201-7
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Parental transmission of type 2 diabetes: the Framingham Offspring Study.
  • We estimated risk for type 2 diabetes and milder degrees of glucose intolerance associated with parental diabetes among subjects of the population-based Framingham Offspring Study, in which participants are primarily Caucasian and at relatively low risk for diabetes and for which both parental and offspring phenotypes were ascertained by direct examination.
  • Parental diabetes, assessed over 40 years of biennial follow-up, was defined by use of hypoglycemic drug therapy or a casual plasma glucose level > or = 11.1 mmol/l at any examination.
  • Offspring glucose tolerance, assessed over 20 years of quadrennial follow-up, was defined by fasting plasma glucose levels > or = 7.8 mmol/l at any two examinations, use of hypoglycemic drug therapy at any examination, or with a 75-g oral glucose tolerance test (1980 World Health Organization criteria) at the most recent examination.
  • We calculated odds ratios (ORs) and 95% CIs for offspring glucose tolerance status using generalized estimating equations to account for differential correlations within and between families.
  • Relative to individuals without parental diabetes, the age-adjusted ORs (95% CI) for offspring type 2 diabetes or abnormal glucose tolerance (fasting plasma glucose > or = 6.1 mmol/l or 2-h postchallenge glucose tolerance > or = 7.8 mmol/l) among individuals with maternal diabetes were 3.4 (2.3-4.9) and 2.7 (2.0-3.7), respectively; among individuals with paternal diabetes were 3.5 (2.3-5.2) and 1.7 (1.2-2.4), respectively; and among individuals with bilineal diabetes were 6.1 (2.9-13.0) and 5.2 (2.6-10.5), respectively.
  • Although maternal and paternal diabetes conferred equivalent risk for offspring type 2 diabetes, offspring with maternal diabetes were slightly more likely to have abnormal glucose tolerance compared with those with paternal diabetes (OR 1.6, 95% CI 1.1-2.4).
  • Offspring with maternal diabetes and an age of onset of <50 years had marked increased risk for both type 2 diabetes (9.7, 4.3-22.0) and abnormal glucose tolerance (9.0, 4.2-19.7).
  • We conclude that risk ratios for offspring type 2 diabetes are consistent with a simple additive risk model, where risk when both parents are affected equals the sum of risk when either parent is affected.
  • For maternal diabetes to confer excess risk for mild but not overt glucose intolerance, offspring of diabetic fathers may transit abnormal to impaired glucose tolerance relatively quickly, or diabetic mothers may transmit risk for a mild slowly progressive form of abnormal glucose tolerance in addition to overt diabetes.
  • Given equivalent risk ratios for type 2 diabetes, fathers may transmit unique paternal genetic factors of similar strength to maternal environmental factors.
  • [MeSH-major] Diabetes Mellitus, Type 2 / genetics. Fathers. Mothers
  • [MeSH-minor] Adult. Aged. Aged, 80 and over. Blood Glucose / analysis. Cohort Studies. Female. Genetic Predisposition to Disease. Glucose Tolerance Test. Humans. Hypoglycemic Agents / therapeutic use. Insulin Resistance / genetics. Male. Middle Aged. Odds Ratio. Prevalence. Randomized Controlled Trials as Topic

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  • (PMID = 11118026.001).
  • [ISSN] 0012-1797
  • [Journal-full-title] Diabetes
  • [ISO-abbreviation] Diabetes
  • [Language] eng
  • [Grant] United States / NHLBI NIH HHS / HC / N01-HC-38083
  • [Publication-type] Journal Article; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, P.H.S.
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Blood Glucose; 0 / Hypoglycemic Agents
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62. Andius P, Damm O, Holmäng S: Prognostic factors in patients with carcinoma in situ treated with intravesical bacille Calmette-Guérin. Scand J Urol Nephrol; 2004;38(4):285-90
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Prognostic factors in patients with carcinoma in situ treated with intravesical bacille Calmette-Guérin.
  • OBJECTIVE: To report prognostic factors and follow-up data for an unselected group of patients with carcinoma in situ (CIS) of the urinary bladder treated with bacille Calmette-Guérin (BCG).
  • MATERIAL AND METHODS: The clinical records of patients with CIS treated with BCG were reviewed.
  • The impact of 18 variables on the times to recurrence and progression was studied using multivariate Cox proportional hazard regression and Kaplan-Meier analyses.
  • RESULTS: No pre-treatment variables, including type of CIS and T1G3 tumour, had prognostic value in terms of time to progression.
  • The result of the first cystoscopy had a very strong prognostic importance: 44% of patients with a positive first cystoscopy progressed in stage, 59% were BCG failures and 35% died from urothelial cancer.
  • The corresponding values for patients with a negative first cystoscopy were 11%, 18% and 8%.
  • Fourteen patients (8%) were diagnosed with an upper urinary tract tumour but no variable had prognostic significance.
  • The accumulated incidence of patients with bladder CIS and a subsequent upper urinary tract tumour is rather high but it is questionable whether the prognosis will improve if routine follow-up urographies are performed.
  • [MeSH-major] BCG Vaccine / therapeutic use. Carcinoma in Situ / drug therapy. Carcinoma in Situ / mortality. Urinary Bladder Neoplasms / drug therapy. Urinary Bladder Neoplasms / mortality
  • [MeSH-minor] Administration, Intravesical. Adult. Aged. Aged, 80 and over. Biopsy, Needle. Confidence Intervals. Cystoscopy. Disease-Free Survival. Dose-Response Relationship, Drug. Drug Administration Schedule. Female. Humans. Immunohistochemistry. Male. Middle Aged. Neoplasm Staging. Prognosis. Proportional Hazards Models. Retrospective Studies. Risk Assessment. Survival Analysis. Sweden. Treatment Outcome

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  • (PMID = 15669587.001).
  • [ISSN] 0036-5599
  • [Journal-full-title] Scandinavian journal of urology and nephrology
  • [ISO-abbreviation] Scand. J. Urol. Nephrol.
  • [Language] eng
  • [Publication-type] Comparative Study; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't
  • [Publication-country] Sweden
  • [Chemical-registry-number] 0 / BCG Vaccine
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63. Cocquyt V, Van Belle S: Lobular carcinoma in situ and invasive lobular cancer of the breast. Curr Opin Obstet Gynecol; 2005 Feb;17(1):55-60
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  • [Title] Lobular carcinoma in situ and invasive lobular cancer of the breast.
  • PURPOSE OF REVIEW: The incidence of lobular carcinoma in situ and invasive lobular carcinoma of the breast is increasing.
  • Recent data suggest that lobular carcinoma in situ is an indolent precursor for breast cancer, rather than a pure risk factor.
  • The risk of contralateral carcinoma and of multifocality of invasive lobular carcinoma is higher than for invasive ductal carcinoma.
  • RECENT FINDINGS: The risk of invasive carcinoma after lobular carcinoma in situ is increased.
  • Invasive carcinoma is usually located at the index point of lobular carcinoma in situ and is of lobular histology.
  • Dynamic contrast-enhanced magnetic resonance imaging can be useful in the detection and preoperative staging of invasive lobular carcinoma.
  • The risk of local recurrence is high in patients with invasive lobular carcinoma.
  • The response to preoperative chemotherapy is worse for invasive lobular carcinoma compared with invasive ductal carcinoma, with a greater need for rescue mastectomy.
  • SUMMARY: Lobular carcinoma in situ and invasive lobular carcinoma are different entities from ductal carcinoma in situ and invasive lobular carcinoma.
  • Their biological profile should be studied further in order to make the fine tuning of treatment possible.
  • [MeSH-major] Antineoplastic Agents / therapeutic use. Breast Neoplasms / surgery. Carcinoma in Situ / surgery. Carcinoma, Lobular / surgery
  • [MeSH-minor] Chemotherapy, Adjuvant. Female. Humans. Incidence. Magnetic Resonance Imaging. Mastectomy, Radical. Mastectomy, Segmental. Neoplasm Invasiveness. Neoplasm Recurrence, Local / epidemiology. Neoplasm Recurrence, Local / etiology. Neoplasm Recurrence, Local / pathology. Neoplasm Staging. Preoperative Care. Prognosis. Risk Factors. Sentinel Lymph Node Biopsy. Survival Rate

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  • (PMID = 15711412.001).
  • [ISSN] 1040-872X
  • [Journal-full-title] Current opinion in obstetrics & gynecology
  • [ISO-abbreviation] Curr. Opin. Obstet. Gynecol.
  • [Language] eng
  • [Publication-type] Journal Article; Review
  • [Publication-country] England
  • [Chemical-registry-number] 0 / Antineoplastic Agents
  • [Number-of-references] 38
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64. Sylvester RJ, van der Meijden AP, Witjes JA, Kurth K: Bacillus calmette-guerin versus chemotherapy for the intravesical treatment of patients with carcinoma in situ of the bladder: a meta-analysis of the published results of randomized clinical trials. J Urol; 2005 Jul;174(1):86-91; discussion 91-2
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  • [Title] Bacillus calmette-guerin versus chemotherapy for the intravesical treatment of patients with carcinoma in situ of the bladder: a meta-analysis of the published results of randomized clinical trials.
  • PURPOSE: We determined the short-term and long-term efficacy of bacillus Calmette-Guerin (BCG) and chemotherapy in the treatment of patients with carcinoma in situ (CIS).
  • MATERIALS AND METHODS: A meta-analysis was performed on published results of randomized clinical trials comparing intravesical BCG to intravesical chemotherapy.
  • RESULTS: Nine randomized trials including 700 patients with CIS compared BCG to either mitomycin C (MMC), epirubicin, adriamycin, or sequential MMC/adriamycin.
  • Of 298 patients on BCG 203 (68.1%) had a complete response compared with 158 of 307 patients on chemotherapy (51.5%), a reduction of 47% in the odds of nonresponse on BCG (OR 0.53, p =0.0002).
  • Based on a median followup of 3.6 years, 161 of 345 patients on BCG (46.7%) had no evidence of disease compared with 93 of 355 patients on chemotherapy (26.2%), a reduction of 59% in the odds of treatment failure on BCG (OR 0.41, p <0.0001).
  • The reduction of 26% in the risk of progression on BCG (p =0.20) is consistent with the reduction of 27% (p =0.001) previously reported in a larger superficial bladder cancer meta-analysis.
  • CONCLUSIONS: Intravesical BCG significantly reduces the risk of short and long-term treatment failure compared with intravesical chemotherapy.
  • Therefore, it is considered to be the intravesical agent of choice in the treatment of CIS.
  • [MeSH-major] Adjuvants, Immunologic / administration & dosage. Antineoplastic Agents / administration & dosage. BCG Vaccine / administration & dosage. Carcinoma in Situ / drug therapy. Urinary Bladder Neoplasms / drug therapy

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  • (PMID = 15947584.001).
  • [ISSN] 0022-5347
  • [Journal-full-title] The Journal of urology
  • [ISO-abbreviation] J. Urol.
  • [Language] eng
  • [Grant] United States / NCI NIH HHS / CA / 5U10-CA11488-34
  • [Publication-type] Comparative Study; Journal Article; Meta-Analysis; Research Support, N.I.H., Extramural; Research Support, U.S. Gov't, P.H.S.
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Adjuvants, Immunologic; 0 / Antineoplastic Agents; 0 / BCG Vaccine
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65. Fischetti G, Barrese F, Cuzari S, Marino C, Mariani S, Morello P: [Neoadjuvant chemotherapy and conservative surgery in invasive bladder cancer. Personal experience]. Minerva Urol Nefrol; 2001 Sep;53(3):119-23
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  • [Title] [Neoadjuvant chemotherapy and conservative surgery in invasive bladder cancer. Personal experience].
  • [Transliterated title] Chemioterapia neoadiuvante e chirurgia conservativa nel carcinoma infiltrante della vescica. Nostr esperienza.
  • BACKGROUND: To evacuate the efficacy of conservative treatment in invasive stage T2 bladder tumours by means of deep transurethral resection of the bladder (TURB) followed by three cycles of chemotherapy with methotrexate, vinblastin, adriamycin and cisplatin (M-VAC).
  • Following histological confirmation of muscle involvement (stage T2), all patients were assigned to the M-VAC chemotherapy protocol after having established clinical stage with chest, abdominal and pelvic computed tomography (CT) and bone scintiscan.
  • Patients were evaluated by means of diagnostic cystoscopy, TURB and bladder mapping, 4 weeks after completing treatment.
  • RESULTS: Of these patients, 4 (80%) completed the treatment protocol.
  • Of these 5 patients 3 (60%) were tumour-free at the follow-up observation 4 weeks after chemotherapy, one patient (20%) still presented with involvement of the bladder wall, and one (20%) presented both with a superficial stage (Ta) and carcinoma in situ (Cis).
  • CONCLUSIONS: Deep TURB followed by three cycles of chemotherapy according to the M-VAC protocol, could be an effective alternative to conservative treatment of stage T2 bladder tumours.
  • [MeSH-major] Urinary Bladder Neoplasms / drug therapy. Urinary Bladder Neoplasms / surgery
  • [MeSH-minor] Aged. Chemotherapy, Adjuvant. Female. Humans. Male. Middle Aged

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  • (PMID = 11723435.001).
  • [ISSN] 0393-2249
  • [Journal-full-title] Minerva urologica e nefrologica = The Italian journal of urology and nephrology
  • [ISO-abbreviation] Minerva Urol Nefrol
  • [Language] ita
  • [Publication-type] English Abstract; Journal Article
  • [Publication-country] Italy
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66. Nakhlis F, Lazarus L, Hou N, Acharya S, Khan SA, Staradub VL, Rademaker AW, Morrow M: Tamoxifen use in patients with ductal carcinoma in situ and T1a/b N0 invasive carcinoma. J Am Coll Surg; 2005 Nov;201(5):688-94
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  • [Title] Tamoxifen use in patients with ductal carcinoma in situ and T1a/b N0 invasive carcinoma.
  • BACKGROUND: The purpose of this study was to determine how often patients with ductal carcinoma in situ and T1a/b N0 cancer are offered and accept tamoxifen for secondary chemoprevention.
  • STUDY DESIGN: A retrospective review of 284 patients with T1a/b N0 invasive cancer treated between February 1995 and December 2001 and 129 patients with DCIS treated after September 1998 was carried out.
  • Patient and tumor characteristics associated with being offered and accepting tamoxifen were compared.
  • RESULTS: Tamoxifen was offered to 67% of the invasive cancer patients and accepted by 76% (51% of the entire group).
  • Tamoxifen was offered to 91% of the ductal carcinoma in situ patients and accepted by 73% (67% overall).
  • CONCLUSIONS: Factors associated with tamoxifen risks and benefits correlate poorly with the use of the drug.
  • [MeSH-major] Antineoplastic Agents, Hormonal / therapeutic use. Breast Neoplasms / drug therapy. Carcinoma, Ductal, Breast / drug therapy. Carcinoma, Intraductal, Noninfiltrating / drug therapy. Tamoxifen / therapeutic use

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  • (PMID = 16256910.001).
  • [ISSN] 1072-7515
  • [Journal-full-title] Journal of the American College of Surgeons
  • [ISO-abbreviation] J. Am. Coll. Surg.
  • [Language] eng
  • [Grant] United States / NCI NIH HHS / CA / P50-CA89018
  • [Publication-type] Comparative Study; Journal Article; Research Support, N.I.H., Extramural; Research Support, U.S. Gov't, P.H.S.
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Antineoplastic Agents, Hormonal; 094ZI81Y45 / Tamoxifen
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67. Griffiths TR, Charlton M, Neal DE, Powell PH: Treatment of carcinoma in situ with intravesical bacillus Calmette-Guerin without maintenance. J Urol; 2002 Jun;167(6):2408-12
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  • [Title] Treatment of carcinoma in situ with intravesical bacillus Calmette-Guerin without maintenance.
  • PURPOSE: Data concerning the relative efficacy of intravesical bacillus Calmette-Guerin (BCG) on subgroups of carcinoma in situ of the bladder are limited.
  • We report the outcome of primary carcinoma in situ and carcinoma in situ associated with Ta or T1 transitional cell carcinoma of the bladder treated with BCG.
  • MATERIALS AND METHODS: Between 1987 and 1997, 135 patients (median age 70 years) with biopsy proven bladder carcinoma in situ underwent a standard course of 6 BCG instillations.
  • Patients were divided into group 1-23 patients with primary carcinoma in situ, group 2-37 with carcinoma in situ associated with Ta transitional cell carcinoma and group 3-75 with carcinoma in situ associated with T1 transitional cell carcinoma.
  • Cancer specific survival rates were 83% (10 of 12 patients), 86% (12 of 14) and 59% (17 of 29), and the numbers of patients alive with the bladder intact were 60% (9 of 15), 58% (11 of 19) and 30% (12 of 40).
  • A complete response to BCG in group 3 patients significantly delayed time to progression (Cox regression p = 0.001) but did not reduce death from transitional cell carcinoma.
  • CONCLUSIONS: A single course of BCG is remarkably effective for primary carcinoma in situ and carcinoma in situ associated with Ta transitional cell carcinoma but is suboptimal in patients with carcinoma in situ associated with T1 transitional cell carcinoma.
  • [MeSH-major] Adjuvants, Immunologic / administration & dosage. BCG Vaccine / administration & dosage. Carcinoma in Situ / drug therapy. Urinary Bladder Neoplasms / drug therapy
  • [MeSH-minor] Administration, Intravesical. Aged. Carcinoma, Transitional Cell / drug therapy. Carcinoma, Transitional Cell / mortality. Disease Progression. Female. Humans. Male. Prognosis. Survival Rate

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  • (PMID = 11992047.001).
  • [ISSN] 0022-5347
  • [Journal-full-title] The Journal of urology
  • [ISO-abbreviation] J. Urol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Adjuvants, Immunologic; 0 / BCG Vaccine
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68. de Oliveira CF, Rodrigues V, Gervásio H, Moura Pereira J, Albano J, Amaral N, Portuguese Senology Society: Carcinoma in situ and early breast carcinoma survey of the Portuguese Senology Society on treatment in Portugal and its evolution between 1985 and 2000. Eur J Gynaecol Oncol; 2004;25(4):415-22
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  • [Title] Carcinoma in situ and early breast carcinoma survey of the Portuguese Senology Society on treatment in Portugal and its evolution between 1985 and 2000.
  • By means of a questionnaire sent to Portuguese hospitals which diagnose and treat most female patients with breast cancer, it was intended to assess the situation regarding the treatment of carcinoma in situ and early breast cancer (T1 or T2, N0 or N1), as well as their evolution between 1985 and 2000.
  • Progress in the surgical approach was similar both in cancer centres and in large and university hospitals, when compared with the other surveyed hospitals.
  • Also, no differences between these two hospital groups in disease-free survival and overall survival were found.
  • Postoperative radiotherapy was employed in more than 90% of the patients submitted to conservative surgery and adjuvant chemotherapy was used in 39% of all the patients, while tamoxifen as adjuvant treatment was used in 58% of the patients.
  • [MeSH-major] Breast Neoplasms / pathology. Breast Neoplasms / therapy. Carcinoma in Situ / pathology. Carcinoma in Situ / therapy. Combined Modality Therapy / standards. Neoplasm Invasiveness / pathology
  • [MeSH-minor] Adult. Age Distribution. Aged. Aged, 80 and over. Biopsy, Needle. Chemotherapy, Adjuvant / standards. Female. Health Care Surveys. Humans. Incidence. Mastectomy / methods. Middle Aged. Neoplasm Staging. Portugal. Prognosis. Radiotherapy, Adjuvant / standards. Survival Rate. Treatment Outcome

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  • (PMID = 15285294.001).
  • [ISSN] 0392-2936
  • [Journal-full-title] European journal of gynaecological oncology
  • [ISO-abbreviation] Eur. J. Gynaecol. Oncol.
  • [Language] eng
  • [Publication-type] Comparative Study; Guideline; Journal Article; Practice Guideline
  • [Publication-country] Italy
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69. Corti L, Toniolo L, Boso C, Colaut F, Fiore D, Muzzio PC, Koukourakis MI, Mazzarotto R, Pignataro M, Loreggian L, Sotti G: Long-term survival of patients treated with photodynamic therapy for carcinoma in situ and early non-small-cell lung carcinoma. Lasers Surg Med; 2007 Jun;39(5):394-402
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  • [Title] Long-term survival of patients treated with photodynamic therapy for carcinoma in situ and early non-small-cell lung carcinoma.
  • PURPOSE: The role of photodynamic therapy (PDT) in the treatment of small cancers has been established in several clinical studies.
  • Here, we report on the efficacy of PDT for early inoperable or recurrent non-small-cell lung cancer (NSCLC).
  • Twelve cases were inoperable for medical reasons and were staged as T1N0M0, and 28 had recurrent in situ carcinoma.
  • Patients with residual disease after PDT received definitive radiotherapy and/or brachytherapy.
  • RESULTS: PDT obtained a 72% complete response (CR) rate (36/50 treated lesions), that is 27 CR among the 37 Tis carcinomas and 9 among the 13 T1 cases.
  • The mean and median survival rates for patients with Tis stage were 86.5 and 120.4 months, respectively (standard error 9.50) and for patients with T1 disease they were 45.78 and 35.71 months, respectively; the difference was statistically significant (P = 0.03).
  • CONCLUSIONS: PDT is effective in early primary or recurrent NSCLC, resulting in a CR rate of 72%.
  • The incorporation of PDT in standard clinical practice, in combination with radiotherapy, warrants further investigation.
  • [MeSH-major] Carcinoma in Situ / drug therapy. Carcinoma in Situ / mortality. Carcinoma, Non-Small-Cell Lung / drug therapy. Carcinoma, Non-Small-Cell Lung / mortality. Lung Neoplasms / drug therapy. Lung Neoplasms / mortality. Photochemotherapy
  • [MeSH-minor] Aged. Dihematoporphyrin Ether / therapeutic use. Disease-Free Survival. Female. Follow-Up Studies. Hematoporphyrin Derivative / therapeutic use. Humans. Male. Middle Aged. Neoplasm Recurrence, Local / drug therapy. Neoplasm Recurrence, Local / mortality. Neoplasm Recurrence, Local / pathology. Photosensitizing Agents / therapeutic use. Retrospective Studies. Survival Rate

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  • [Copyright] (c) 2007 Wiley-Liss, Inc.
  • (PMID = 17565719.001).
  • [ISSN] 0196-8092
  • [Journal-full-title] Lasers in surgery and medicine
  • [ISO-abbreviation] Lasers Surg Med
  • [Language] eng
  • [Publication-type] Journal Article; Research Support, Non-U.S. Gov't
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Photosensitizing Agents; 68335-15-9 / Hematoporphyrin Derivative; 97067-70-4 / Dihematoporphyrin Ether
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70. Akaza H, Koiso K, Ozono S, Kuroda M, Kameyama S, Okajima E, Kotake T, Kakizoe T, Kawabe K, PMCJ-9 Study Group in Japan: A clinical study of PMCJ-9 (Bacillus Calmette-Guérin Connaught strain) treatment of superficial bladder cancer and carcinoma in situ of the bladder. Jpn J Clin Oncol; 2003 Aug;33(8):382-90
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  • [Title] A clinical study of PMCJ-9 (Bacillus Calmette-Guérin Connaught strain) treatment of superficial bladder cancer and carcinoma in situ of the bladder.
  • BACKGROUND: Intravesical Bacillus Calmette-Guérin (BCG) is now a standard treatment for Ta, T1 carcinoma and carcinoma in situ (CIS) of the urinary bladder.
  • We therefore designed a clinical study of PMCJ-9 (BCG Connaught strain) for obtaining approval from Japanese Ministry of Health, Labor and Welfare.
  • METHODS: In the phase I-II study, PMCJ-9 40.5, 81 (standard dose overseas) or 121.5 mg in saline was instilled into the bladder of patients with Ta, T1 or CIS once weekly for 8 weeks.
  • The incidence of adverse drug reactions (ADRs) was similar in all groups, but four 121.5 mg group patients developed severe ADRs.
  • In that study, 39 patients were evaluable, showing CR rates of 71.8% (28/39) overall and 61.5% (16/26) and 92.3% (12/13) for the Ta, T1 and CIS cases.
  • PMCJ-9 administration at this dose level weekly for 8 weeks showed a clear antitumor effect and good safety profile against Ta, T1 and CIS transitional cell carcinoma of the bladder.
  • [MeSH-major] BCG Vaccine / administration & dosage. Carcinoma in Situ / therapy. Carcinoma, Transitional Cell / therapy. Immunotherapy. Urinary Bladder Neoplasms / therapy

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  • (PMID = 14523057.001).
  • [ISSN] 0368-2811
  • [Journal-full-title] Japanese journal of clinical oncology
  • [ISO-abbreviation] Jpn. J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Clinical Trial; Clinical Trial, Phase I; Clinical Trial, Phase II; Journal Article; Research Support, Non-U.S. Gov't
  • [Publication-country] Japan
  • [Chemical-registry-number] 0 / BCG Connaught; 0 / BCG Vaccine
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71. Katusin D, Poka Z, Mlinac-Lucijanić M, Kriz M, Klarić-Vucinić S, Ilijanić J: [Carcinoma in situ in the urinary bladder]. Lijec Vjesn; 2000 Jul-Aug;122(7-8):177-9
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  • [Title] [Carcinoma in situ in the urinary bladder].
  • [Transliterated title] Karcinom in situ mokraćnog mjehura.
  • In this paper we have presented seven patients with carcinoma in situ of the urinary bladder, a rare intraepithelial form of transitional cell carcinoma of the urinary bladder, described first in 1952.
  • In all patients malignant cells were detected in urine sediment, and the diagnosis was proven histopathologicaly by random biopsies of the urinary bladder.
  • In five patients carcinoma in situ was associated with papillary bladder tumor, while two patients had primary carcinoma in situ.
  • In all patients a complete response was achieved after local immunotherapy or local chemotherapy.
  • After a follow-up lasting from 23 to 61 months in one patient a recurrent carcinoma in situ was diagnosed, while six patients show no signs of recurrent disease.
  • [MeSH-major] Carcinoma in Situ. Carcinoma, Transitional Cell. Urinary Bladder Neoplasms

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  • (PMID = 11048460.001).
  • [ISSN] 0024-3477
  • [Journal-full-title] Lijec̆nic̆ki vjesnik
  • [ISO-abbreviation] Lijec Vjesn
  • [Language] hrv
  • [Publication-type] English Abstract; Journal Article
  • [Publication-country] CROATIA
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72. Tsukagoshi S: [ImmuCyst intravesical (freeze-dried preparation made from the connaught strain of Bacillus Calmette Guérin) for the treatment of superficial bladder cancer and carcinoma in situ of urinary bladder]. Gan To Kagaku Ryoho; 2003 Jul;30(7):1027-38
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  • [Title] [ImmuCyst intravesical (freeze-dried preparation made from the connaught strain of Bacillus Calmette Guérin) for the treatment of superficial bladder cancer and carcinoma in situ of urinary bladder].
  • However, in 1976, Morales et al. reported the effective use against superficial bladder cancer by intravesical administration.
  • In Japan, in July, 1994, Rhone-Poulenc Rorer Japan Inc, started the cooperative clinical studies with Nippon Kayaku Co. Ltd. as an orphan drug.
  • In the late phase II study, in which 81 mg were given, CR rates in 39 response evaluable cases, was 61.5% (16/26), response rate (CR + PR) was 85.6% (22/26), and CR rate of CIS was 92.6% (12/13).
  • There were responded cases in the recurred cases and those with previous chemotherapy, and the adverse reactions were polyurea, urination pain, urination difficulty, hematurea, malaise and loss of appetite mainly.
  • CONCLUSION: Compared with anticancer drug treatments, BCG prevented the recurrence the disease for a long time.
  • From these studies, freeze-dried BCG preparation (immu-Cyst) seemed to be very useful for the treatment of superficial bladder cancer and carcinoma in situ of urinary bladder.
  • [MeSH-major] Adjuvants, Immunologic / administration & dosage. BCG Vaccine / administration & dosage. Carcinoma in Situ / therapy. Urinary Bladder Neoplasms / therapy
  • [MeSH-minor] Administration, Intravesical. Clinical Trials, Phase I as Topic. Clinical Trials, Phase II as Topic. Drug Administration Schedule. Humans. Immunotherapy. Neoplasm Recurrence, Local / prevention & control. Survival Rate. Urination Disorders / etiology

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  • (PMID = 12894724.001).
  • [ISSN] 0385-0684
  • [Journal-full-title] Gan to kagaku ryoho. Cancer & chemotherapy
  • [ISO-abbreviation] Gan To Kagaku Ryoho
  • [Language] jpn
  • [Publication-type] English Abstract; Journal Article; Review
  • [Publication-country] Japan
  • [Chemical-registry-number] 0 / Adjuvants, Immunologic; 0 / BCG Connaught; 0 / BCG Vaccine
  • [Number-of-references] 30
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73. Järvinen R, Kaasinen E, Sankila A, Rintala E, FinnBladder Group: Long-term efficacy of maintenance bacillus Calmette-Guérin versus maintenance mitomycin C instillation therapy in frequently recurrent TaT1 tumours without carcinoma in situ: a subgroup analysis of the prospective, randomised FinnBladder I study with a 20-year follow-up. Eur Urol; 2009 Aug;56(2):260-5
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  • [Title] Long-term efficacy of maintenance bacillus Calmette-Guérin versus maintenance mitomycin C instillation therapy in frequently recurrent TaT1 tumours without carcinoma in situ: a subgroup analysis of the prospective, randomised FinnBladder I study with a 20-year follow-up.
  • BACKGROUND: The long-term prospective data on bacillus Calmette-Guérin (BCG) and mitomycin C (MMC) instillation therapy are limited.
  • OBJECTIVE: To compare the long-term benefit of BCG and MMC maintenance therapy in patients with recurrent bladder carcinoma.
  • DESIGN, SETTING, AND PARTICIPANTS: Eighty-nine patients with frequently recurrent TaT1 disease without carcinoma in situ (CIS) were eligible.
  • Overall median follow-up time was 8.5 yr, whereas the median follow-up time of the patients who were still alive was 19.4 yr.
  • MEASUREMENTS: Primary end points were time to first recurrence and overall mortality.
  • Secondary end points were progression and disease-specific mortality.
  • This finding was reflected in significantly lower cumulative incidence estimates in the BCG group (p=0.005).
  • There was a weak trend for fewer progressions (p=0.1) and cancer-specific deaths (p=0.2) in the cumulative incidence analysis, as 4 patients versus 10 patients progressed and 4 patients versus 9 patients died from the disease in the BCG group versus the MMC group, respectively.
  • CONCLUSIONS: An intensive intravesical BCG immunotherapy results in a sustained and significant long-term reduction in recurrence in frequently recurrent bladder carcinoma.
  • The relatively low progression rate during the long follow-up suggests that it may be difficult to show significant differences in overall mortality with a substantially larger but otherwise similar study population.
  • TRIAL REGISTRATION: Registration was not considered to be necessary at this stage of the follow-up because the study was initiated as early as 1984 and the last randomisation took place in July 1987, that is, long before the current requirements concerning study registrations were implemented.
  • [MeSH-major] Adjuvants, Immunologic / therapeutic use. Antibiotics, Antineoplastic / administration & dosage. Antibiotics, Antineoplastic / therapeutic use. BCG Vaccine / therapeutic use. Mitomycin / administration & dosage. Mitomycin / therapeutic use. Neoplasm Recurrence, Local / drug therapy. Urinary Bladder Neoplasms / drug therapy
  • [MeSH-minor] Administration, Intravesical. Adult. Aged. Aged, 80 and over. Female. Follow-Up Studies. Humans. Male. Middle Aged. Neoplasm Staging. Prospective Studies. Randomized Controlled Trials as Topic. Time Factors

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  • [CommentIn] Eur Urol. 2009 Aug;56(2):266-8; discussion 268-9 [19427110.001]
  • (PMID = 19395154.001).
  • [ISSN] 1873-7560
  • [Journal-full-title] European urology
  • [ISO-abbreviation] Eur. Urol.
  • [Language] eng
  • [Publication-type] Comparative Study; Journal Article
  • [Publication-country] Switzerland
  • [Chemical-registry-number] 0 / Adjuvants, Immunologic; 0 / Antibiotics, Antineoplastic; 0 / BCG Vaccine; 50SG953SK6 / Mitomycin
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74. Lamm DL, Blumenstein BA, Crissman JD, Montie JE, Gottesman JE, Lowe BA, Sarosdy MF, Bohl RD, Grossman HB, Beck TM, Leimert JT, Crawford ED: Maintenance bacillus Calmette-Guerin immunotherapy for recurrent TA, T1 and carcinoma in situ transitional cell carcinoma of the bladder: a randomized Southwest Oncology Group Study. J Urol; 2000 Apr;163(4):1124-9
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Maintenance bacillus Calmette-Guerin immunotherapy for recurrent TA, T1 and carcinoma in situ transitional cell carcinoma of the bladder: a randomized Southwest Oncology Group Study.
  • PURPOSE: Bacillus Calmette-Guerin (BCG) immunotherapy has been widely accepted as the optimal treatment for carcinoma in situ and high grade superficial transitional cell carcinoma.
  • However, controversy remains regarding the role of maintenance therapy, and its long-term effect on recurrence and progression.
  • MATERIALS AND METHODS: All patients in the study had transitional cell carcinoma of the bladder with carcinoma in situ or an increased risk of recurrence.
  • The criteria for increased risk were 2 or more episodes of tumor within the most recent year, or 3 or more tumors within 6 months.
  • At least 1 week following biopsy of carcinoma in situ and resection of any stage Ta or T1 transitional cell tumors 660 patients were started on a 6-week induction course of intravesical and percutaneous Connaught BCG.
  • Three months following initiation of BCG induction therapy 550 consenting patients were stratified by purified protein derivative skin test and the presence of carcinoma in situ, and then randomized by central computer to receive BCG maintenance therapy (maintenance arm) or no BCG maintenance therapy (no maintenance arm).
  • Maintenance therapy consisted of intravesical and percutaneous BCG each week for 3 weeks given 3, 6, 12, 18, 24, 30 and 36 months from initiation of induction therapy.
  • The 384 eligible patients who were disease-free at randomization constitute the primary intent to treat analytic group because they could be followed for disease recurrence.
  • All patients were followed for adverse effects of treatment, recurrence, disease worsening and survival.
  • Estimated median time for worsening-free survival, defined as no evidence of progression including pathological stage T2 disease or greater, or the use of cystectomy, systemic chemotherapy or radiation therapy, was 111.5 months in the no maintenance and not estimable in the maintenance arm (log rank p = 0.04).
  • CONCLUSIONS: Compared to standard induction therapy maintenance BCG immunotherapy was beneficial in patients with carcinoma in situ and select patients with Ta, T1 bladder cancer.
  • Median recurrence-free survival time was twice as long in the 3-week maintenance arm compared to the no maintenance arm, and patients had significantly longer worsening-free survival.
  • [MeSH-major] Adjuvants, Immunologic / therapeutic use. BCG Vaccine / therapeutic use. Carcinoma in Situ / pathology. Carcinoma in Situ / therapy. Carcinoma, Transitional Cell / pathology. Carcinoma, Transitional Cell / therapy. Neoplasm Recurrence, Local / pathology. Neoplasm Recurrence, Local / therapy. Neoplasms, Multiple Primary / pathology. Neoplasms, Multiple Primary / therapy. Urinary Bladder Neoplasms / drug therapy. Urinary Bladder Neoplasms / pathology

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  • (PMID = 10737480.001).
  • [ISSN] 0022-5347
  • [Journal-full-title] The Journal of urology
  • [ISO-abbreviation] J. Urol.
  • [Language] eng
  • [Grant] United States / NCI NIH HHS / CA / CA04919; United States / NCI NIH HHS / CA / CA32102; United States / NCI NIH HHS / CA / CA38926; etc
  • [Publication-type] Clinical Trial; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, P.H.S.
  • [Publication-country] UNITED STATES
  • [Chemical-registry-number] 0 / Adjuvants, Immunologic; 0 / BCG Vaccine
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75. Kuznetsov DD, Alsikafi NF, O'Connor RC, Steinberg GD: Intravesical valrubicin in the treatment of carcinoma in situ of the bladder. Expert Opin Pharmacother; 2001 Jun;2(6):1009-13
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Intravesical valrubicin in the treatment of carcinoma in situ of the bladder.
  • The propensity of patients with carcinoma in situ (CIS) of the bladder to progress to invasive and metastatic disease is clearly established.
  • Today, the standard therapy in treating patients with CIS of the bladder is intravesical bacillus Calmette-Guerin (BCG).
  • Valrubicin (N-trifluoroacetyladriamycin-14-valerate) is a new semisynthetic derivative of the anthracycline antibiotic doxorubicin that has been shown to benefit patients with BCG-refractory CIS of the bladder.
  • Early non-randomised studies show promise and the current utilisation of this drug is limited to patients with BCG-refractory CIS of the bladder who are not good surgical candidates.
  • Randomised studies of intravesical valrubicin for the treatment of superficial bladder cancer are ongoing.
  • [MeSH-major] Antineoplastic Agents / therapeutic use. Carcinoma in Situ / drug therapy. Carcinoma, Transitional Cell / drug therapy. Doxorubicin / therapeutic use. Urinary Bladder Neoplasms / drug therapy
  • [MeSH-minor] Administration, Intravesical. Clinical Trials as Topic. Guidelines as Topic. Humans. Molecular Structure

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  • (PMID = 11585003.001).
  • [ISSN] 1465-6566
  • [Journal-full-title] Expert opinion on pharmacotherapy
  • [ISO-abbreviation] Expert Opin Pharmacother
  • [Language] eng
  • [Publication-type] Journal Article; Review
  • [Publication-country] England
  • [Chemical-registry-number] 0 / Antineoplastic Agents; 2C6NUM6878 / valrubicin; 80168379AG / Doxorubicin
  • [Number-of-references] 33
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76. Lee SH, Kim MJ, Lee HJ, Kim SJ, Park JS, Hur SY: A case of inguinal lymph node squamous cell carcinoma of unknown origin, accompanied with carcinoma in situ of cervix. J Gynecol Oncol; 2008 Jun;19(2):145-9

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] A case of inguinal lymph node squamous cell carcinoma of unknown origin, accompanied with carcinoma in situ of cervix.
  • Metastatic Cancer of Unknown Primary Site (CUP) accounts for approximately 3-5% of all malignant neoplasms.
  • CUP represents a heterogeneous group of metastatic tumors for which no primary site can be detected following a thorough medical history, careful clinical examination, and extensive diagnostic work-up.
  • Several authors have reported poor prognosis of this malignancy, because there is no consensus on diagnostic guidelines and optimal therapy.
  • Historically, chemotherapy has been the cornerstone of treatment for patients with CUP.
  • We experienced a case of inguinal lymph node squamous cell carcinoma of unknown origin, accompanied with carcinoma in situ of the cervix.
  • We report this case with a brief review of the literatures.

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  • (PMID = 19471557.001).
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  • [Keywords] NOTNLM ; Inguinal lymph node / Metastatic cancer of unknown primary site
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77. Kim JC, Steinberg GD: Medical management of patients with refractory carcinoma in situ of the bladder. Drugs Aging; 2001;18(5):335-44
Hazardous Substances Data Bank. VALRUBICIN .

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Medical management of patients with refractory carcinoma in situ of the bladder.
  • Bladder cancer is a common genitourinary malignancy and carcinoma in situ (CIS) of the bladder exists as a potentially aggressive variant of the superficial form of the disease.
  • Treatment must reflect the unpredictable nature of this disease entity.
  • In 1976, the use of intravesical Bacillus Calmette-Guerin (BCG) was described for the management of early stage bladder cancer.
  • A subsequent report demonstrated efficacy in a cohort of patients with CIS of the bladder.
  • Since this time, intravesical BCG has been recognised as the initial therapy for CIS of the bladder.
  • Although a 6-week treatment with intravesical BCG has been established as standard therapy in patients with CIS, there has been no consensus as to the subsequent treatment for patients in the setting of failure to initial management with BCG.
  • In addition, a number of reports have demonstrated an increased potential of adverse effects after repeated treatment with intravesical BCG.
  • A variety of alternative immunological and chemotherapeutic agents have been developed in response to the limitations of BCG for patients with refractory CIS of the bladder.
  • At present, valrubicin remains the only agent that is approved by the US Food and Drug Administration for the specific indication of CIS of the bladder unresponsive to intravesical BCG.
  • Although these agents appear promising, the most efficacious therapy remains to be determined.
  • The specific treatment protocol for refractory CIS of the bladder remains elusive.
  • It is ultimately the combined decision of the clinician and patient to determine which course of management is most beneficial.
  • [MeSH-major] Carcinoma in Situ / therapy. Urinary Bladder Neoplasms / therapy
  • [MeSH-minor] Antineoplastic Agents / therapeutic use. BCG Vaccine / adverse effects. BCG Vaccine / therapeutic use. Doxorubicin / analogs & derivatives. Doxorubicin / therapeutic use. Humans. Immunotherapy. Photochemotherapy

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  • (PMID = 11392442.001).
  • [ISSN] 1170-229X
  • [Journal-full-title] Drugs & aging
  • [ISO-abbreviation] Drugs Aging
  • [Language] eng
  • [Publication-type] Journal Article; Review
  • [Publication-country] New Zealand
  • [Chemical-registry-number] 0 / Antineoplastic Agents; 0 / BCG Vaccine; 2C6NUM6878 / valrubicin; 80168379AG / Doxorubicin
  • [Number-of-references] 79
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78. Uekado Y, Kohjimoto Y, Iba A, Kikkawa K, Shintani Y, Shinka T: [Efficacy of intravesical bacillus Calmette-Guerin for carcinoma in situ of bladder]. Hinyokika Kiyo; 2006 Jun;52(6):439-44
MedlinePlus Health Information. consumer health - Bladder Cancer.

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] [Efficacy of intravesical bacillus Calmette-Guerin for carcinoma in situ of bladder].
  • Three months after an initial 6-week course ofintravesical bacillus Calmette-Guerin (BCG) given between January 1990 and March 2005, 94 (90%) out of 104 patients with carcinoma in situ (CIS) of the bladder achieved a complete response (CR).
  • Three months after a second course ofintravesical BCG given to 23 patients who failed the initial induction course for CIS was evaluated.
  • Only one patient who received a second course of BCG therapy showed disease progression.
  • Two of the 4 patients with BCG-refractory CIS of the bladder achieved CR after intravesical gemcitabine therapy and maintained a tumor-free status beyond 6 months.
  • Five of the 16 patients showing disease progression had upper urinary tract cancer, 4 had recurrent or muscle invasive bladder cancer, 6 had prostatic involvement of CIS, and one patient had urethral recurrence.
  • Bladder preservation was achieved in 97 of the 104 patients, although 7 patients ultimately underwent radical cystectomy and urinary diversion for aggressive disease.
  • In conclusion, some patients may be managed safely by repeated endoscopic resection and intravesical therapy with cystectomy postponed until objective evidence of progression exists.
  • [MeSH-major] Adjuvants, Immunologic / therapeutic use. BCG Vaccine / therapeutic use. Carcinoma in Situ / drug therapy. Urinary Bladder Neoplasms / drug therapy
  • [MeSH-minor] Administration, Intravesical. Adult. Aged. Aged, 80 and over. Female. Humans. Male. Middle Aged. Remission Induction. Treatment Outcome

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  • (PMID = 16848357.001).
  • [ISSN] 0018-1994
  • [Journal-full-title] Hinyokika kiyo. Acta urologica Japonica
  • [ISO-abbreviation] Hinyokika Kiyo
  • [Language] jpn
  • [Publication-type] English Abstract; Journal Article
  • [Publication-country] Japan
  • [Chemical-registry-number] 0 / Adjuvants, Immunologic; 0 / BCG Vaccine
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79. Kokubo M, Mitsumori M, Kanehira K, Inamoto T, Mise K, Kodama H, Yamabe H, Hiraoka M: Results of breast-conserving therapy for ductal carcinoma in situ: the Kyoto University experiences. Breast Cancer; 2001;8(2):153-7
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Results of breast-conserving therapy for ductal carcinoma in situ: the Kyoto University experiences.
  • BACKGROUND: The purpose of this study was to evaluate the results of breast-conserving therapy (BCT), defined as the combination of breast-conserving surgery with axillary dissection and definitive radiation therapy for ductal carcinoma in situ (DCIS).
  • Radiation therapy consisted of 50 Gy to the ipsilateral whole breast.
  • Boost irradiation of 10 Gy was given to 15 patients with close or positive margins.
  • Nearly all patients received adjuvant chemotherapy with 5-fluorouracil or its derivatives and adjuvant endocrine therapy with tamoxifen for 2 years.
  • Only one patient had a non-invasive local recurrence, 23 months after her operation.
  • The five-year local control rate was 97%.
  • CONCLUSION: The results of this retrospective study substantiate favorable data and appear to confirm the efficacy and reasonable local recurrence rate of BCT for the treatment of DCIS.
  • [MeSH-major] Breast Neoplasms / surgery. Carcinoma, Intraductal, Noninfiltrating / surgery. Mastectomy, Segmental
  • [MeSH-minor] Adult. Aged. Combined Modality Therapy. Female. Follow-Up Studies. Humans. Japan / epidemiology. Middle Aged. Prognosis

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  • (PMID = 11342989.001).
  • [ISSN] 1340-6868
  • [Journal-full-title] Breast cancer (Tokyo, Japan)
  • [ISO-abbreviation] Breast Cancer
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] Japan
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80. Heffelfinger SC, Gear RB, Schneider J, LaDow K, Yan M, Lu F, Pyle AL, Warshawsky D: TNP-470 inhibits 7,12-dimethylbenz[a]anthracene-induced mammary tumor formation when administered before the formation of carcinoma in situ but is not additive with tamoxifen. Lab Invest; 2003 Jul;83(7):1001-11
Hazardous Substances Data Bank. 7,12-DIMETHYLBENZ(A)ANTHRACENE .

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] TNP-470 inhibits 7,12-dimethylbenz[a]anthracene-induced mammary tumor formation when administered before the formation of carcinoma in situ but is not additive with tamoxifen.
  • In many women pathologic lesions, such as hyperplasia and carcinoma in situ, precede invasive breast cancer.
  • We have shown that tissue vascularity increases with histologic progression to invasive disease.
  • Similarly, in the well-characterized 7,12-dimethylbenz[a]anthracene (DMBA) model of mammary tumorigenesis, preinvasive lesions exhibit increased vascularity with progression.
  • Using this model we asked whether inhibition of angiogenesis would block progression and if so, at which stage.
  • Early TNP-470 and tamoxifen treatment inhibited the formation of carcinoma in situ (p < 0.001) and invasive disease (p < 0.001).
  • TNP-470 administration begun at the time of microscopic carcinoma in situ formation was unable to prevent the further development of carcinoma in situ or invasive breast cancer, whereas tamoxifen was highly effective (p = 0.001).
  • TNP-470 therapy, unlike tamoxifen, did not inhibit the angiogenic potential of DMBA-treated normal mammary organoids, supporting its lack of a direct effect on the epithelium.
  • These data provide proof-in-principle that inhibition of angiogenesis early in mammary tumorigenesis prevents mammary tumor formation in a hormone-sensitive model, indicating that angiogenesis is a potential target for cancer chemoprevention.
  • [MeSH-major] Angiogenesis Inhibitors / therapeutic use. Antibiotics, Antineoplastic / therapeutic use. Carcinoma in Situ / prevention & control. Carcinoma, Intraductal, Noninfiltrating / prevention & control. Mammary Neoplasms, Experimental / prevention & control. Precancerous Conditions / prevention & control. Sesquiterpenes / therapeutic use. Tamoxifen / therapeutic use
  • [MeSH-minor] 9,10-Dimethyl-1,2-benzanthracene / toxicity. Animals. Carcinogens / toxicity. Cyclohexanes. Disease Models, Animal. Drug Interactions. Female. Neovascularization, Pathologic. Rats. Rats, Sprague-Dawley

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  • (PMID = 12861040.001).
  • [ISSN] 0023-6837
  • [Journal-full-title] Laboratory investigation; a journal of technical methods and pathology
  • [ISO-abbreviation] Lab. Invest.
  • [Language] eng
  • [Grant] United States / NCI NIH HHS / CA / R01-CA82996
  • [Publication-type] Journal Article; Research Support, U.S. Gov't, P.H.S.
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Angiogenesis Inhibitors; 0 / Antibiotics, Antineoplastic; 0 / Carcinogens; 0 / Cyclohexanes; 0 / Sesquiterpenes; 094ZI81Y45 / Tamoxifen; 129298-91-5 / O-(chloroacetylcarbamoyl)fumagillol; 57-97-6 / 9,10-Dimethyl-1,2-benzanthracene
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81. Jakse G, Hall R, Bono A, Höltl W, Carpentier P, Spaander JP, van der Meijden AP, Sylvester R: Intravesical BCG in patients with carcinoma in situ of the urinary bladder: long-term results of EORTC GU Group phase II protocol 30861. Eur Urol; 2001 Aug;40(2):144-50
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  • [Title] Intravesical BCG in patients with carcinoma in situ of the urinary bladder: long-term results of EORTC GU Group phase II protocol 30861.
  • OBJECTIVES: This phase II study was designed to assess the response rate, side effects and long-term efficacy of BCG in the treatment of carcinoma in situ (Cis) of the urinary bladder.
  • METHODS: 103 eligible patients with Cis were treated with 6 consecutive weekly intravesical instillations of 120 mg BCG-Connaught.
  • After a median follow-up of 7.6 years, 39 of the 77 CR patients (50%) are still alive and have retained their bladder, 31 (40%) without tumor recurrence.
  • Another 7 patients underwent cystectomy and are still alive while 16 (20%) have died due to bladder cancer.
  • Ten patients stopped treatment due to toxicity.
  • Drug cystitis, bacterial cystitis and fever occurred in 45, 15 and 15% of the patients, respectively.
  • Severe drug cystitis was noted in 3 out of 10 patients receiving more than 6 instillations, necessitating cystectomy in 1 case.
  • CONCLUSION: Intravesical short-term BCG is an effective treatment modality in Cis, yielding a high CR rate.
  • This therapy may however be suboptimal in some patients as the 5-year disease-free rate in complete responders drops to 60%.
  • [MeSH-major] Adjuvants, Immunologic / administration & dosage. BCG Vaccine / administration & dosage. Carcinoma in Situ / drug therapy. Urinary Bladder Neoplasms / drug therapy
  • [MeSH-minor] Administration, Intravesical. Adult. Aged. Aged, 80 and over. Female. Humans. Male. Middle Aged. Time Factors

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  • (PMID = 11528191.001).
  • [ISSN] 0302-2838
  • [Journal-full-title] European urology
  • [ISO-abbreviation] Eur. Urol.
  • [Language] eng
  • [Grant] United States / NCI NIH HHS / CA / 3U10-CA11488-18S1; United States / NCI NIH HHS / CA / 5U10-CA11488-18; United States / NCI NIH HHS / CA / 5U10-CA11488-18S2; United States / NCI NIH HHS / CA / 5U10-CA11488-19; United States / NCI NIH HHS / CA / 5U10-CA11488-20
  • [Publication-type] Clinical Trial; Clinical Trial, Phase II; Journal Article; Research Support, U.S. Gov't, P.H.S.
  • [Publication-country] Switzerland
  • [Chemical-registry-number] 0 / Adjuvants, Immunologic; 0 / BCG Vaccine
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82. Jurincic-Winkler CD, Metz KA, Beuth J, Klippel KF: Keyhole limpet hemocyanin for carcinoma in situ of the bladder: a long-term follow-up study. Eur Urol; 2000;37 Suppl 3:45-9
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  • [Title] Keyhole limpet hemocyanin for carcinoma in situ of the bladder: a long-term follow-up study.
  • OBJECTIVE: Keyhole limpet hemocyanin (KLH) is a nonspecific immunomodulator, demonstrated to be clinically effective in superficial bladder cancer.
  • The present study investigated the clinical efficacy of intravesical KLH in patients with carcinoma in situ (CIS) with a long-term follow-up.
  • METHODS: Thirteen patients with CIS grade III were treated with intravesical instillations of KLH, 20 mg for 6 weeks, then monthly for 1 year and bimonthly for 2 subsequent years.
  • Two patients were free of tumor after KLH instillations with a follow-up of 66 and 82 months, respectively.
  • All patients who did not respond to the primary KLH course, but to the 'rescue' instillation of BCG, experienced recurrences after 42, 48, 56 and 60 months after the first KLH instillation treatment.
  • Three patients with recurrent CIS and who were not cystectomized had recurrences after prolonged remission (4-5 years).
  • CONCLUSIONS: KLH demonstrates efficacy and induces long- term remissions against CIS in a limited number of cases.
  • In the present study, most patients with CIS progressed over time whatever the substance instilled, whether KLH or BCG.
  • CIS remains a very aggressive neoplasm requiring a lifelong follow-up.
  • Further studies are necessary to define the precise role of KLH in patients with CIS.
  • [MeSH-major] Adjuvants, Immunologic / therapeutic use. Carcinoma in Situ / drug therapy. Hemocyanin / therapeutic use. Urinary Bladder Neoplasms / drug therapy
  • [MeSH-minor] Aged. Aged, 80 and over. Female. Follow-Up Studies. Humans. Male. Middle Aged. Time Factors

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  • [Copyright] Copyright 2000 S. Karger AG, Basel
  • (PMID = 10828687.001).
  • [ISSN] 0302-2838
  • [Journal-full-title] European urology
  • [ISO-abbreviation] Eur. Urol.
  • [Language] eng
  • [Publication-type] Clinical Trial; Journal Article
  • [Publication-country] SWITZERLAND
  • [Chemical-registry-number] 0 / Adjuvants, Immunologic; 9013-72-3 / Hemocyanin; FV4Y0JO2CX / keyhole-limpet hemocyanin
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83. D'Ugo D, Persiani R, Pende V, Picciocchi A: [Neoadjuvant chemotherapy in gastric carcinoma]. Ann Ital Chir; 2001 Jan-Feb;72(1):47-53
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  • [Title] [Neoadjuvant chemotherapy in gastric carcinoma].
  • [Transliterated title] La chemioterapia neoadiuvante nel cancro gastrico.
  • A complete surgical resection currently represents the only curative treatment option for gastric carcinoma, but as regards locally advanced cancer the possibility of local or distant recurrence remains extremely high even following a R0 resection.
  • As far as T3-4/N+ tumors are concerned, unsatisfying results of surgery alone have stressed the need for multimodal treatments: in the recent past adjuvant chemotherapy has represented a common complementary treatment for locally advanced gastric cancer, but conclusive results of most randomized trials did not show a significant impact on long term survival.
  • Literature review shows a growing trend throughout the 90's towards the adoption of a preoperative chemotherapy, initially evaluated as a form of "salvage" palliative treatment for unresectable patients.
  • To date a number of phase II study suggests the efficacy of neo-adjuvant treatment administered to resectable patients with the purpose of inducing tumor downstaging, increasing the rate of R0 resections and controlling recurrencies.
  • From March 1996 the Authors have started a controlled study on neo-adjuvant therapy for locally advanced gastric cancer.
  • In this ongoing study, patients are administered two preoperative cycles of EEP chemotherapy (Etoposide, Epirubicin, cis-Platin).
  • Restaging has not shown progression of the disease in 13/14 cases; a macroscopic response was evidenced in 7/14 patients; 14/14 patients could undergo a successful D2 surgical resection following neo-adjuvant therapy.
  • Pathological staging confirmed tumor downstaging in 7 out of 14 cases; 12/14 patients in this group (85.7%) could benefit a R0 resection.
  • [MeSH-major] Adenocarcinoma / drug therapy. Adenocarcinoma / surgery. Stomach Neoplasms / drug therapy. Stomach Neoplasms / surgery
  • [MeSH-minor] Chemotherapy, Adjuvant. Humans

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  • (PMID = 11464495.001).
  • [ISSN] 0003-469X
  • [Journal-full-title] Annali italiani di chirurgia
  • [ISO-abbreviation] Ann Ital Chir
  • [Language] ita
  • [Publication-type] Clinical Trial; Clinical Trial, Phase II; English Abstract; Journal Article; Review
  • [Publication-country] Italy
  • [Number-of-references] 22
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84. Goh MS: Invasive squamous cell carcinoma after treatment of carcinoma in situ with 5% imiquimod cream. Australas J Dermatol; 2006 Aug;47(3):186-8
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  • [Title] Invasive squamous cell carcinoma after treatment of carcinoma in situ with 5% imiquimod cream.
  • Squamous cell carcinoma in situ has the potential to progress to invasive squamous cell carcinoma.
  • This report presents two cases of punch biopsy-proven squamous cell carcinoma in situ, treated with once-daily application of 5% imiquimod cream for 6 weeks.
  • Both patients developed moderate local inflammatory reactions during treatment.
  • The first patient demonstrated clinical clearance of the scalp lesion after treatment.
  • Two months later, he re-presented with a subcutaneous nodule at the same site.
  • Histology was consistent with recurrent squamous cell carcinoma.
  • Five months following excision of the recurrent tumour, he presented with metastatic squamous cell carcinoma to a cervical lymph node.
  • The second patient had low-grade chronic lymphocytic leukaemia and presented with squamous cell carcinoma in situ of the leg that failed to clear clinically after treatment with imiquimod.
  • He presented 4 months later with a focus of invasive squamous cell carcinoma within the lesion.
  • [MeSH-major] Aminoquinolines / administration & dosage. Antineoplastic Agents / administration & dosage. Carcinoma in Situ / drug therapy. Carcinoma, Squamous Cell / drug therapy. Neoplasms, Second Primary / diagnosis. Skin Neoplasms / drug therapy
  • [MeSH-minor] Administration, Topical. Aged, 80 and over. Disease Progression. Head and Neck Neoplasms / diagnosis. Head and Neck Neoplasms / drug therapy. Head and Neck Neoplasms / surgery. Humans. Leg. Lymph Node Excision. Lymphatic Metastasis. Male. Middle Aged. Scalp. Treatment Outcome

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  • (PMID = 16867000.001).
  • [ISSN] 0004-8380
  • [Journal-full-title] The Australasian journal of dermatology
  • [ISO-abbreviation] Australas. J. Dermatol.
  • [Language] eng
  • [Publication-type] Case Reports; Journal Article
  • [Publication-country] Australia
  • [Chemical-registry-number] 0 / Aminoquinolines; 0 / Antineoplastic Agents; 99011-02-6 / imiquimod
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85. Palou Redorta J, Schatteman P, Huguet Pérez J, Segarra Tomás J, Rosales Bordes A, Algaba F, Villavicencio Mavrich H: Intravesical instillations with bacillus calmette-guérin for the treatment of carcinoma in situ involving prostatic ducts. Eur Urol; 2006 May;49(5):834-8; discussion 838
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  • [Title] Intravesical instillations with bacillus calmette-guérin for the treatment of carcinoma in situ involving prostatic ducts.
  • OBJECTIVES: Bacillus Calmette-Guérin (BCG) has proven its efficacy in the treatment of carcinoma in situ (CIS) of the prostatic urethra.
  • We performed a retrospective study to evaluate the use of intravesical instillations of BCG in patients with carcinoma in situ involving prostatic ducts after complete transurethral resection (TUR).
  • MATERIAL AND METHODS: Eligibility for the study was CIS of the prostatic urethra involving prostatic ducts.
  • TUR loop biopsies of the prostate were performed only when a macroscopic tumor was present.
  • RESULTS: In this retrospective study of 11 patients, 8 (73%) presented with macroscopic tumor in the prostatic urethra.
  • Ten patients (91%) had a simultaneous superficial bladder carcinoma.
  • After a median follow-up of 27 mo (n=10 patients), the response in the prostatic urethra was 82%, and the response in the bladder due to superficial tumor recurrence was 64%.
  • Two patients with residual ductal disease in the prostatic urethra were subsequently treated with cystoprostatectomy and are currently free of disease.
  • Another patient developed distant metastatic disease and died a few months after diagnosis.
  • Currently, 90% of patients are alive without evidence of disease and 72.7% have benefitted from this bladder preservation strategy.
  • CONCLUSION: Intravesical BCG is a feasible treatment option for patients with CIS involving prostatic ducts.
  • Obviously, these patients need a careful follow-up with cystoscopy and cytology to detect either recurrence or progression and in those with persistent disease after the initial BCG induction therapy, prompt cystectomy is indicated.
  • [MeSH-major] Adjuvants, Immunologic / administration & dosage. BCG Vaccine / administration & dosage. Carcinoma in Situ / drug therapy. Prostatic Neoplasms / drug therapy. Urethral Neoplasms / drug therapy
  • [MeSH-minor] Administration, Intravesical. Aged. Aged, 80 and over. Biopsy. Cystectomy. Cystoscopy. Diagnosis, Differential. Follow-Up Studies. Humans. Instillation, Drug. Male. Middle Aged. Neoplasm Staging. Retrospective Studies. Transurethral Resection of Prostate. Treatment Outcome

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  • (PMID = 16426729.001).
  • [ISSN] 0302-2838
  • [Journal-full-title] European urology
  • [ISO-abbreviation] Eur. Urol.
  • [Language] eng
  • [Publication-type] Comparative Study; Journal Article
  • [Publication-country] Switzerland
  • [Chemical-registry-number] 0 / Adjuvants, Immunologic; 0 / BCG Vaccine
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86. Kochs C, Hanneken S, Schulte KW, Reifenberger J: [Treatment of carcinoma in situ of erythema ab igne with photodynamic therapy]. Hautarzt; 2008 Oct;59(10):777-9
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  • [Title] [Treatment of carcinoma in situ of erythema ab igne with photodynamic therapy].
  • [Transliterated title] Behandlung eines Carcinoma in situ bei Erythema ab igne mittels photodynamischer Therapie.
  • The clinical picture of EAI is characterized by reticulate erythema, desquamation, and teleangiectasias.
  • Complications of EAI include increasing cutaneous atrophy and predisposition to malignant tumors.
  • The paramount goal of therapy is to eliminate the cause.
  • Individual case reports of EAI with established epithelial dysplasia in the sense of carcinoma in situ have described good response of the neoplastic alterations to topical application of 5-fluorouracil or imiquimod.
  • In our case we achieved successful results with photodynamic therapy.
  • [MeSH-major] Carcinoma in Situ / drug therapy. Erythema / drug therapy. Photochemotherapy / methods. Photosensitizing Agents / therapeutic use. Skin Neoplasms / drug therapy. Valerates / therapeutic use

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  • [Cites] J Am Acad Dermatol. 2004 Jun;50(6):973-4 [15153907.001]
  • [Cites] J Drugs Dermatol. 2008 May;7(5):488-9 [18505146.001]
  • [Cites] Int J Dermatol. 1999 May;38(5):361-6 [10369546.001]
  • [Cites] CMAJ. 2000 Jan 11;162(1):77-8 [11216204.001]
  • [Cites] Cutis. 2007 Oct;80(4):319-20 [18038695.001]
  • [Cites] Arch Dermatol. 1979 Oct;115(10):1226-8 [507871.001]
  • (PMID = 18773179.001).
  • [ISSN] 1432-1173
  • [Journal-full-title] Der Hautarzt; Zeitschrift fur Dermatologie, Venerologie, und verwandte Gebiete
  • [ISO-abbreviation] Hautarzt
  • [Language] ger
  • [Publication-type] Case Reports; English Abstract; Journal Article
  • [Publication-country] Germany
  • [Chemical-registry-number] 0 / Photosensitizing Agents; 0 / Valerates
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87. Adamczewski Z, Makarewicz J, Mikosiński S, Knapska-Kucharska M, Gunerska-Szadkowska A, Oszukowska L, Karwowska A, Lewiński A: [Application of 13-cis-retinoic acid in patients with 131I scintigraphically-negative metastases of differentiated thyroid carcinoma]. Endokrynol Pol; 2006 Jul-Aug;57(4):403-6
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  • [Title] [Application of 13-cis-retinoic acid in patients with 131I scintigraphically-negative metastases of differentiated thyroid carcinoma].
  • [Transliterated title] Zastosowanie kwasu 13-cis-retinowego u pacjentów z nieniejodochwytnymi przerzutami zrózcowanego raka tarczycy.
  • INTRODUCTION: The loss of iodine uptake by differentiated thyroid carcinoma (DTC) cells is a major therapeutic problem especially in patients with nonsurgical metastatic foci or local recurrence.
  • Using 13-cis-retinoic acid, it was attempted to retain iodine uptake as a result of redifferentiation (influence by retinoic acid receptors present in DTC cells).
  • MATERIAL AND METHODS: Between 1999 and 2005, 13-cis-retinoic acid was used in 11 patients with disseminated PTC and high serum level of thyroglobulin (Tg) before (131)I treatment (2 patients were treated twice - 13 treatment cycles in total).
  • Side effects in skin and mucous membranes were observed in all the patients, however, their intensity did not require termination of the therapy.
  • CONCLUSIONS: 13-cis-retinoic acid causes an increase of radioiodine uptake in around half of treated patients, however, the follow-up of these patients indicates that this increase does not result in either full remission or even stabilisation of neoplastic disease.
  • The possibility should be considered to use cis-retinoic acid as an independent therapeutic approach in patients with radioiodine non-avid foci of thyroid carcinoma especially those showing high expression of RARb and RXRg receptors.
  • [MeSH-major] Carcinoma, Papillary / drug therapy. Carcinoma, Papillary / radiotherapy. Iodine Radioisotopes / pharmacokinetics. Isotretinoin / therapeutic use. Thyroid Neoplasms / drug therapy. Thyroid Neoplasms / radiotherapy
  • [MeSH-minor] Adult. Aged. Female. Humans. Male. Middle Aged. Neoplasm Recurrence, Local / diagnostic imaging. Neoplasm Recurrence, Local / drug therapy. Neoplasm Recurrence, Local / radiotherapy. Radionuclide Imaging. Thyroglobulin / blood. Treatment Outcome. Whole-Body Counting

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  • (PMID = 17006844.001).
  • [ISSN] 0423-104X
  • [Journal-full-title] Endokrynologia Polska
  • [ISO-abbreviation] Endokrynol Pol
  • [Language] pol
  • [Publication-type] Journal Article
  • [Publication-country] Poland
  • [Chemical-registry-number] 0 / Iodine Radioisotopes; 9010-34-8 / Thyroglobulin; EH28UP18IF / Isotretinoin
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88. Morvan A, de Korvin B, Bouriel C, Carsin A, Tas P, Bendavid C, Dupré PF, Kerbrat P, Mesbah H, Poree P, Levêque J: [MRI evaluation of residual breast carcinoma after neoadjuvant chemotherapy]. J Radiol; 2010 Jun;91(6):693-9
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  • [Title] [MRI evaluation of residual breast carcinoma after neoadjuvant chemotherapy].
  • [Transliterated title] Cancer du sein traité par chimiothérapie néoadjuvante: évaluation du reliquat tumoral par l'IRM mammaire.
  • PURPOSE: This study aims to evaluate the sensibility and specificity of MRI in the detection and size measuring of residual breast cancer in patients treated with neoadjuvant chemotherapy before surgery.
  • PATIENTS AND METHODS: This is a retrospective study of 32 women, who underwent breast MRI before and after neoadjuvant treatment.
  • RESULTS: The sensibility of MRI to assess pathologic Complete Response (no invasive residual tumor) was excellent (100%) but the specificity was low (55,5%).
  • There was no false negative case and four false positive cases (Two ductal carcinomas in situ and two scars-like fibrosis).
  • When MRI outcomes were compared with the presence or absence of invasive or in situ residual carcinoma, only one false negative case was noticed (one "in situ" residual tumor).
  • The correlation between tumor size measured by MRI and histopathology was low (r=0,32).
  • Underestimations of tumor size were due to non-continuous tumor regression or invasive lobular carcinoma or association of invasive carcinoma and intra ductal breast cancer.
  • Over estimations of tumor size were due to chemotherapy-induced changes.
  • CONCLUSION: MRI is a sensitive but poorly specific method to assess the pathological complete response after neoadjuvant chemotherapy.
  • Estimation of tumor size and detection of isolated residual in situ carcinoma are fare.
  • [MeSH-major] Breast Neoplasms / diagnosis. Breast Neoplasms / drug therapy. Magnetic Resonance Imaging. Neoplasm, Residual / diagnosis
  • [MeSH-minor] Adult. Chemotherapy, Adjuvant. Female. Humans. Middle Aged. Neoadjuvant Therapy. Retrospective Studies

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  • (PMID = 20808270.001).
  • [ISSN] 0221-0363
  • [Journal-full-title] Journal de radiologie
  • [ISO-abbreviation] J Radiol
  • [Language] fre
  • [Publication-type] English Abstract; Journal Article
  • [Publication-country] France
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89. Gaya JM, Palou J, Algaba F, Arce J, Rodríguez-Faba O, Villavicencio H: The case for conservative management in the treatment of patients with non-muscle-invasive micropapillary bladder carcinoma without carcinoma in situ. Can J Urol; 2010 Oct;17(5):5370-6
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  • [Title] The case for conservative management in the treatment of patients with non-muscle-invasive micropapillary bladder carcinoma without carcinoma in situ.
  • INTRODUCTION: Micropapillary carcinoma is a rare pathologic variant of urothelial cell carcinoma.
  • Intravesical bacillus Calmette-Guérin (BCG) has been reported to be ineffective and to entail an increased risk of development of non-organ-confined, metastatic disease.
  • We assess the treatment response and disease progression in patients with micropapillary carcinoma of the bladder.
  • MATERIALS AND METHODS: The study comprised 18 patients with micropapillary carcinoma of the bladder who underwent transurethral resection of a bladder tumor and multiple random biopsies between 1997 and 2003.
  • We retrospectively analyzed treatment response and clinical and pathological cancer evolution related to cancer stage and the percentage of the micropapillary component of the cancer.
  • RESULTS: Seven of the 18 patients (38.8%) had carcinoma in situ.
  • At diagnosis, 8 of the 18 patients had non-muscle-invasive bladder cancer; 6 of these patients were treated with intravesical BCG therapy and were alive and free of disease at a median follow up of more than 5 years.
  • Ten of the 18 patients had muscle-invasive bladder cancer; 8 of these patients underwent radical cystectomy, and 7 of the 8 patients (87.5%) had non-organ-confined disease in cystectomy specimens.
  • Seventy percent of patients with muscle-invasive disease at diagnosis had a micropapillary carcinoma component of more than 50% in transurethral resection of the bladder specimens, compared with only 25% of patients with non-muscle-invasive disease.
  • Patients treated successfully with intravesical BCG therapy had a low micropapillary carcinoma component.
  • The 5-year disease-specific survival rate was significantly lower in patients with muscle-invasive disease (30%) than in patients with non-muscle-invasive disease (87.5%) after a median follow up of 52 months (p = 0.001), and it was also significantly lower in patients with a high percentage of the micropapillary component of the carcinoma.
  • CONCLUSIONS: This retrospective study of 18 patients with micropapillary carcinoma of the bladder suggests that tumor stage and patient outcome may be related to the percentage of the micropapillary component of the carcinoma.
  • Radical surgery is mandatory in muscle-invasive disease, even though patients with lymph node involvement die from the disease.
  • In non-muscle-invasive disease and in the absence of associated carcinoma in situ, intravesical BCG treatment may be offered when the micropapillary component of the carcinoma component is a small percentage.
  • [MeSH-major] Adjuvants, Immunologic / therapeutic use. BCG Vaccine / therapeutic use. Carcinoma in Situ / drug therapy. Carcinoma in Situ / pathology. Carcinoma, Papillary / drug therapy. Carcinoma, Papillary / pathology. Urinary Bladder Neoplasms / drug therapy. Urinary Bladder Neoplasms / pathology
  • [MeSH-minor] Aged. Aged, 80 and over. Cystectomy. Disease Progression. Female. Humans. Kaplan-Meier Estimate. Male. Middle Aged. Neoplasm Invasiveness. Neoplasm Staging. Retrospective Studies. Statistics, Nonparametric. Survival Analysis. Treatment Outcome. Urothelium / pathology

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  • (PMID = 20974029.001).
  • [ISSN] 1195-9479
  • [Journal-full-title] The Canadian journal of urology
  • [ISO-abbreviation] Can J Urol
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] Canada
  • [Chemical-registry-number] 0 / Adjuvants, Immunologic; 0 / BCG Vaccine
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90. Handkiewicz-Junak D, Roskosz J, Turska M, Wygoda Z, Jarzab B: [Use of 13-cis retinoic acid for treatment of advanced differentiated thyroid cancer]. Wiad Lek; 2001;54 Suppl 1:301-6
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  • [Title] [Use of 13-cis retinoic acid for treatment of advanced differentiated thyroid cancer].
  • [Transliterated title] Zastosowanie kwasu 13-cis-retinowego w leczeniu zaawansowanego zróznicowanego raka tarczycy.
  • Retinoids, a large group of compounds structurally related to vitamin A, are able to induce redifferentiation of thyroid cancer cells.
  • The aim of the study is to present our early results of retinoids redifferentiation therapy of thyroid cancer patients.
  • In 15 patients with advanced thyroid cancer, whose cancer foci did not concentrate radioiodine, 13-cis retinoic acid (Roaccutan) was given for 6 weeks before radioiodine treatment.
  • Radioiodine therapy was performed under exogenous TSH stimulation (Thyrogen).
  • In post-therapeutic scintigraphy radioiodine uptake was visible in two out of seven patients (29%) with lung metastases, in 5 out of 9 (56%) with locoregional disease and in two with bone metastases.
  • Thyroglobulin concentration before and after retinoids therapy did not differ significantly.
  • CONCLUSIONS: In a subgroup of patients 13-cis retinoic acid can induce radioiodine uptake, however, prospective studies in larger groups of patients are necessary to prove its clinical application.
  • [MeSH-major] Isotretinoin / administration & dosage. Premedication. Thyroid Neoplasms / drug therapy. Thyroid Neoplasms / radiotherapy
  • [MeSH-minor] Adult. Aged. Bone Neoplasms / drug therapy. Bone Neoplasms / metabolism. Bone Neoplasms / radiotherapy. Bone Neoplasms / secondary. Female. Humans. Iodine Radioisotopes / pharmacokinetics. Lung Neoplasms / drug therapy. Lung Neoplasms / metabolism. Lung Neoplasms / radiotherapy. Lung Neoplasms / secondary. Male. Middle Aged. Thyroglobulin / metabolism

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  • (PMID = 12182039.001).
  • [ISSN] 0043-5147
  • [Journal-full-title] Wiadomości lekarskie (Warsaw, Poland : 1960)
  • [ISO-abbreviation] Wiad. Lek.
  • [Language] pol
  • [Publication-type] Clinical Trial; English Abstract; Journal Article
  • [Publication-country] Poland
  • [Chemical-registry-number] 0 / Iodine Radioisotopes; 9010-34-8 / Thyroglobulin; EH28UP18IF / Isotretinoin
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91. Koga H, Ozono S, Tsushima T, Tomita K, Horiguchi Y, Usami M, Hirao Y, Akaza H, Naito S, BCG Tokyo Strain Study Group: Maintenance intravesical bacillus Calmette-Guérin instillation for Ta, T1 cancer and carcinoma in situ of the bladder: randomized controlled trial by the BCG Tokyo Strain Study Group. Int J Urol; 2010 Sep;17(9):759-66
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Maintenance intravesical bacillus Calmette-Guérin instillation for Ta, T1 cancer and carcinoma in situ of the bladder: randomized controlled trial by the BCG Tokyo Strain Study Group.
  • OBJECTIVES: We carried out a prospective, randomized, controlled trial to investigate the efficacy and safety of both induction and maintenance therapy with intravesical instillation of bacillus Calmette-Guérin (BCG) for high-risk non-muscle invasive bladder cancer (NMIBC).
  • METHODS: Intravesical instillation of 80 mg Tokyo strain was given to patients with high-risk NMIBC, including carcinoma in situ (CIS), once weekly for eight consecutive weeks as induction therapy.
  • After induction therapy, 75% of the patients achieved CR and 53 of them were enrolled in the randomized comparative phase.
  • Univariate analysis identified maintenance therapy as a significant factor influencing recurrence.
  • During induction therapy, 82.2% of patients experienced urination-related adverse drug reactions, but most events were not serious.
  • There were fewer adverse drug reactions with maintenance therapy than with induction therapy.
  • Neither induction therapy nor maintenance therapy reduced patients' quality of life (QOL).
  • CONCLUSIONS: These findings show high levels of efficacy and safety of BCG induction treatment for high-risk NMIBC, and suggest that the number of maintenance instillations could probably be reduced without reducing treatment efficacy or influencing QOL.
  • [MeSH-major] Adjuvants, Immunologic / administration & dosage. BCG Vaccine / administration & dosage. Carcinoma in Situ / drug therapy. Urinary Bladder Neoplasms / drug therapy

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  • [CommentIn] Int J Urol. 2010 Sep;17(9):766-7 [20727047.001]
  • (PMID = 20604814.001).
  • [ISSN] 1442-2042
  • [Journal-full-title] International journal of urology : official journal of the Japanese Urological Association
  • [ISO-abbreviation] Int. J. Urol.
  • [Language] eng
  • [Publication-type] Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
  • [Publication-country] Australia
  • [Chemical-registry-number] 0 / Adjuvants, Immunologic; 0 / BCG Vaccine
  • [Investigator] Tsukamoto T; Suzuki T; Arai Y; Kitamura Y; Miyanaga N; Tobe T; Fukui I; Tomita K; Horiguchi Y; Asano K; Baba S; Furuse H; Sakagami H; Ono Y; Tozawa K; Fujimoto K; Nishiyama H; Nomoto T; Usami M; Shinka T; Kamidono S; Tsushima T; Terai A; Sumiyoshi Y; Naito K; Naito S; Yamaguchi A; Nomata K; Koiso K; Matsumura Y; Hinotsu S
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92. Wasserberg N, Morgenstern S, Schachter J, Fenig E, Lelcuk S, Gutman H: Risk factors for lymph node metastases in breast ductal carcinoma in situ with minimal invasive component. Arch Surg; 2002 Nov;137(11):1249-52
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Risk factors for lymph node metastases in breast ductal carcinoma in situ with minimal invasive component.
  • HYPOTHESIS: Clinical and pathological variables may be predictors of axillary dissemination in T1mic and T1a breast carcinoma.
  • PATIENTS: All patients diagnosed as having ductal carcinoma in situ (DCIS) with microinvasion between January 1, 1988, and December 30, 1998.
  • MAIN OUTCOME MEASURES: Pathology slides were reviewed according to the 1997 Cancer Staging Manual put forth by the American Joint Committee on Cancer.
  • Patients with no invasive component or invasive components larger than 5 mm were excluded.
  • Pathological and clinical variables were analyzed for their effect on axillary lymph node metastases.
  • RESULTS: The study group included 57 women aged 37 to 71 years (median, 60 years), 37 with T1mic disease and 20 with T1a.
  • Forty-seven patients received adjuvant therapy (radiotherapy alone, or with hormones or chemotherapy).
  • One patient was unavailable for follow-up, another died of disseminated disease, and a third developed contralateral primary carcinoma.
  • [MeSH-major] Breast Neoplasms / pathology. Carcinoma, Intraductal, Noninfiltrating / pathology. Lymph Node Excision. Lymphatic Metastasis / diagnosis

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  • (PMID = 12413311.001).
  • [ISSN] 0004-0010
  • [Journal-full-title] Archives of surgery (Chicago, Ill. : 1960)
  • [ISO-abbreviation] Arch Surg
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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93. Lin CC, Hsu CH, Cheng JC, Huang CY, Tsai YC, Hsu FM, Huang KH, Cheng AL, Pu YS: Induction cisplatin and fluorouracil-based chemotherapy followed by concurrent chemoradiation for muscle-invasive bladder cancer. Int J Radiat Oncol Biol Phys; 2009 Oct 1;75(2):442-8
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Induction cisplatin and fluorouracil-based chemotherapy followed by concurrent chemoradiation for muscle-invasive bladder cancer.
  • PURPOSE: To evaluate a multimodality bladder-preserving therapy in patients with muscle-invasive bladder cancer.
  • METHODS AND MATERIALS: Patients with stages T2-4aN0M0 bladder cancer suitable for cystectomy underwent radical transurethral resection and induction chemotherapy, followed by concurrent chemoradiotherapy (CCRT).
  • Patients with a Karnofsky performance status (KPS) <80 or age > or =70 years underwent Protocol A: induction chemotherapy with three cycles of the cisplatin and 5-fluorouracil (CF) regimen, and CCRT with six doses of weekly cisplatin and 64.8 Gy radiotherapy given with the shrinking-field technique.
  • Patients with KPS > or =80 and age <70 years underwent Protocol B: induction chemotherapy with three cycles of weekly paclitaxel plus the CF regimen, and CCRT with six doses of weekly paclitaxel and cisplatin plus 64.8 Gy radiotherapy.
  • Interval cystoscopy was employed after induction chemotherapy and when radiotherapy reached 43.2 Gy.
  • After induction chemotherapy, 23 patients achieved CR.
  • Overall, 28 patients (93%) completed the protocol treatment.
  • Of 22 patients who completed CCRT, 1 had recurrence with carcinoma in situ and 3 had distant metastases.
  • [MeSH-major] Urinary Bladder Neoplasms / drug therapy. Urinary Bladder Neoplasms / radiotherapy
  • [MeSH-minor] Aged. Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Cisplatin / administration & dosage. Clinical Protocols. Combined Modality Therapy / adverse effects. Combined Modality Therapy / methods. Cystectomy. Drug Administration Schedule. Female. Fluorouracil / administration & dosage. Follow-Up Studies. Humans. Karnofsky Performance Status. Male. Paclitaxel / administration & dosage. Radiotherapy Dosage. Remission Induction. Salvage Therapy. Survival Rate

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  • (PMID = 19307067.001).
  • [ISSN] 1879-355X
  • [Journal-full-title] International journal of radiation oncology, biology, physics
  • [ISO-abbreviation] Int. J. Radiat. Oncol. Biol. Phys.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
  • [Chemical-registry-number] P88XT4IS4D / Paclitaxel; Q20Q21Q62J / Cisplatin; U3P01618RT / Fluorouracil
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94. Feneley MR, Mellon JK: Management dilemmas in bladder cancer: radical TUR +/- systemic chemotherapy in the treatment of muscle-invasive bladder cancer. Semin Urol Oncol; 2000 Nov;18(4):300-7
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Management dilemmas in bladder cancer: radical TUR +/- systemic chemotherapy in the treatment of muscle-invasive bladder cancer.
  • This case report follows the course of a highly aggressive bladder cancer that presented with carcinoma in situ and illustrates the rapid rate of progression from superficial to invasive disease that may be observed in some individuals.
  • This discussion focuses on the combination of radical transurethral resection (TUR) and systemic chemotherapy as a therapeutic alternative to cystectomy.
  • The concept, technique, indications, and contraindications of radical TUR, and the rationale for combination systemic chemotherapy are discussed with reference to this case.
  • We consider the value of radical TUR and systemic chemotherapy as an alternative to cystectomy and the reasons why this patient would not have been a suitable candidate for this bladder-sparing approach.
  • [MeSH-major] Antineoplastic Agents / therapeutic use. Carcinoma in Situ / drug therapy. Carcinoma in Situ / surgery. Carcinoma, Papillary / drug therapy. Carcinoma, Papillary / surgery. Urinary Bladder Neoplasms / drug therapy. Urinary Bladder Neoplasms / surgery
  • [MeSH-minor] Combined Modality Therapy. Female. Humans. Middle Aged. Neoplasm Invasiveness. Urinary Bladder / pathology. Urinary Bladder / surgery

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  • (PMID = 11101094.001).
  • [ISSN] 1081-0943
  • [Journal-full-title] Seminars in urologic oncology
  • [ISO-abbreviation] Semin. Urol. Oncol.
  • [Language] eng
  • [Publication-type] Case Reports; Journal Article; Review
  • [Publication-country] UNITED STATES
  • [Chemical-registry-number] 0 / Antineoplastic Agents
  • [Number-of-references] 33
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95. Oliver RT, Ong J, Berney D, Nargund V, Badenoch D, Shamash J: Testis conserving chemotherapy in germ cell cancer: its potential to increase understanding of the biology and treatment of carcinoma-in-situ. APMIS; 2003 Jan;111(1):86-91; discussion 91-2
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Testis conserving chemotherapy in germ cell cancer: its potential to increase understanding of the biology and treatment of carcinoma-in-situ.
  • Prompted by recognition of the potential of chemotherapy to increase the success of testis conserving surgery in patients with germ cell cancer, background and outcome data are reviewed and their contribution to the ongoing debate about how germ cell cancer develops discussed.
  • The review is based on three previous studies of: a) time trends in tumour size in 578 personal series of all stages of testis cancer treated since 1978;.
  • b) impact of chemotherapy on actuarial risk of tumours in contralateral testis examined on 1221 patients treated in trials through the Anglian Germ Cell Cancer Consortium; and c) testes conservation attempted using chemotherapy in 78 patients.
  • Since 1978 tumour size has decreased from 4.8 to 3.0 cms while cure has gone from 77 to 97%.
  • There was no overall long term reduction in second cancers beyond 10 years in stage 1 patients after orchidectomy alone compared to stage 1 or metastatic disease patients receiving chemotherapy though the incidence was non significantly lower up to 10 years particularly in those patients receiving etoposide based combination.
  • An additional 25 (32%) had no viable cancer in orchidectomy specimen.
  • In the 28 primary tumours cured by chemotherapy there was a 26% late relapse rate between 5 and 10 years (all cured by orchidectomy) compared to less than 5% in those cured with established metastases.
  • In conclusion, testis conservation with chemotherapy is safe and feasible, though relapse is too frequent for routine service use.
  • Confirmation of the high frequency of late relapse by others has raised the question whether these recurrences are due to post pubertal events reinducing CIS in intrauterine oestrogen primed germ cells and highlights the potential of testes conservation studies to better understand germ cell cancer development.
  • [MeSH-major] Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Carcinoma in Situ / drug therapy. Neoplasm Recurrence, Local. Neoplasms, Germ Cell and Embryonal / drug therapy. Neoplasms, Second Primary. Testicular Neoplasms / drug therapy. Testis / pathology
  • [MeSH-minor] Bleomycin / administration & dosage. Cisplatin / administration & dosage. Combined Modality Therapy. Etoposide / administration & dosage. Humans. Male. Neoplasm Metastasis. Orchiectomy. Time Factors. Vinblastine / administration & dosage

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  • (PMID = 12752243.001).
  • [ISSN] 0903-4641
  • [Journal-full-title] APMIS : acta pathologica, microbiologica, et immunologica Scandinavica
  • [ISO-abbreviation] APMIS
  • [Language] eng
  • [Publication-type] Comparative Study; Journal Article; Meta-Analysis
  • [Publication-country] Denmark
  • [Chemical-registry-number] 11056-06-7 / Bleomycin; 5V9KLZ54CY / Vinblastine; 6PLQ3CP4P3 / Etoposide; Q20Q21Q62J / Cisplatin
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96. Nieder AM, Simon MA, Kim SS, Manoharan M, Soloway MS: Radical cystectomy after bacillus Calmette-Guérin for high-risk Ta, T1, and carcinoma in situ: defining the risk of initial bladder preservation. Urology; 2006 Apr;67(4):737-41
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Radical cystectomy after bacillus Calmette-Guérin for high-risk Ta, T1, and carcinoma in situ: defining the risk of initial bladder preservation.
  • OBJECTIVES: To critically evaluate the survival of patients with high-grade Ta or T1 urothelial cancer (UC) or carcinoma in situ of the bladder who have received bacillus Calmette-Guérin (BCG) and who have undergone radical cystectomy.
  • The mean time from the first BCG course to the date of cystectomy was 27.9 months.
  • The risk of progression to muscle invasion for those who underwent cystectomy less than or more than 1 year from the time of their first BCG dose was 59% and 36%, respectively (P = 0.05).
  • The disease-specific survival rate was 81% versus 80% for those who underwent early versus delayed cystectomy (P = 0.9).
  • CONCLUSIONS: Patients with high-grade UC are at risk of dying from this cancer, even if they ultimately undergo cystectomy.
  • Patients who receive BCG should be appropriately counseled that they remain at risk for disease progression and death from UC.
  • It is difficult to ascertain the proper time to proceed with cystectomy if an initial bladder conservation approach is used.
  • [MeSH-major] Adjuvants, Immunologic / therapeutic use. BCG Vaccine / therapeutic use. Carcinoma in Situ / drug therapy. Carcinoma in Situ / surgery. Carcinoma, Transitional Cell / drug therapy. Carcinoma, Transitional Cell / surgery. Cystectomy. Urinary Bladder Neoplasms / drug therapy. Urinary Bladder Neoplasms / surgery
  • [MeSH-minor] Aged. Combined Modality Therapy. Female. Humans. Male. Neoplasm Staging. Retrospective Studies. Risk Factors

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  • [CommentIn] Eur Urol. 2006 Aug;50(2):383-4 [18219733.001]
  • (PMID = 16618564.001).
  • [ISSN] 1527-9995
  • [Journal-full-title] Urology
  • [ISO-abbreviation] Urology
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Adjuvants, Immunologic; 0 / BCG Vaccine
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97. de Reijke TM, Kurth KH, Sylvester RJ, Hall RR, Brausi M, van de Beek K, Landsoght KE, Carpentier P, European Organization for the Research and Treatment of Cancer-Genito-Urinary Group: Bacillus Calmette-Guerin versus epirubicin for primary, secondary or concurrent carcinoma in situ of the bladder: results of a European Organization for the Research and Treatment of Cancer--Genito-Urinary Group Phase III Trial (30906). J Urol; 2005 Feb;173(2):405-9
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Bacillus Calmette-Guerin versus epirubicin for primary, secondary or concurrent carcinoma in situ of the bladder: results of a European Organization for the Research and Treatment of Cancer--Genito-Urinary Group Phase III Trial (30906).
  • PURPOSE: We compared the efficacy and side effects of intravesical instillations of bacillus Calmette-Guerin (BCG) and epirubicin in patients with carcinoma in situ (CIS) of the bladder.
  • MATERIALS AND METHODS: Patients with primary, secondary or concurrent CIS of the bladder were randomized to 81 mg BCG-Connaught (6 weekly instillations) or 50 mg epirubicin (8 weekly instillations).
  • When a complete response (CR), defined as no Ta/T1 or CIS on biopsy and negative cytology, was obtained, patients in the 2 groups received maintenance instillations at months 3, 6, 12, 18, 24, 30 and 36.
  • When no complete response was observed, the original treatment was repeated, followed again by cystoscopy and biopsies plus cytology.
  • The majority (52%) had concurrent CIS.
  • Primary and secondary CIS was found in 23% and 24% of cases, respectively.
  • When tumor was found following 2 instillation courses, further treatment was left to the investigator (BCG in 29 cases and epirubicin in 37).
  • Time to bladder tumor recurrence after CR was longer in patients treated with BCG vs epirubicin (median 5.1 vs 1.4 years).
  • CIS recurrences were more frequently observed in complete responders to epirubicin (45% vs 16%).
  • No differences in time to progression or duration of survival were observed.
  • Side effects were more frequently seen in patients on BCG with 26 on BCG and 8 on epirubicin stopping treatment due to side effects.
  • Time to recurrence was significantly longer in patients treated with BCG after having achieved a CR.
  • More CIS recurrences were found in patients treated with epirubicin.
  • For time to progression and survival longer followup is warranted.
  • [MeSH-major] Adjuvants, Immunologic / therapeutic use. Antibiotics, Antineoplastic / therapeutic use. BCG Vaccine / therapeutic use. Carcinoma in Situ / drug therapy. Epirubicin / therapeutic use. Neoplasms, Multiple Primary / drug therapy. Urinary Bladder Neoplasms / drug therapy
  • [MeSH-minor] Aged. Aged, 80 and over. Disease Progression. Female. Humans. Male. Middle Aged. Neoplasm Metastasis. Survival Rate. Time Factors

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  • [CommentIn] J Urol. 2005 Sep;174(3):1151; author reply 1151 [16094088.001]
  • (PMID = 15643181.001).
  • [ISSN] 0022-5347
  • [Journal-full-title] The Journal of urology
  • [ISO-abbreviation] J. Urol.
  • [Language] eng
  • [Publication-type] Clinical Trial; Clinical Trial, Phase III; Comparative Study; Journal Article; Randomized Controlled Trial
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Adjuvants, Immunologic; 0 / Antibiotics, Antineoplastic; 0 / BCG Vaccine; 3Z8479ZZ5X / Epirubicin
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98. Ondo AL, Mings SM, Pestak RM, Shanler SD: Topical combination therapy for cutaneous squamous cell carcinoma in situ with 5-fluorouracil cream and imiquimod cream in patients who have failed topical monotherapy. J Am Acad Dermatol; 2006 Dec;55(6):1092-4
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Topical combination therapy for cutaneous squamous cell carcinoma in situ with 5-fluorouracil cream and imiquimod cream in patients who have failed topical monotherapy.
  • Topical therapeutic options for cutaneous squamous cell carcinoma in situ include 5-fluorouracil cream and imiquimod cream.
  • Such treatment may be preferable to surgical or destructive modalities in certain anatomic locations and in instances where patients are unwilling or poor surgical candidates.
  • We present 4 such patients with cutaneous squamous cell carcinoma in situ involving a digit.
  • Each patient failed treatment with imiquimod cream as monotherapy.
  • In addition, two patients failed treatment with 5-fluorouracil cream as monotherapy.
  • All 4 responded completely to 5-fluorouracil and imiquimod cream as combination therapy.
  • In patients who have failed monotherapy with a topical agent for cutaneous squamous cell carcinoma in situ, combination treatment using both topical 5-fluorouracil cream and imiquimod cream may be considered as an alternative therapeutic strategy.
  • [MeSH-major] Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Carcinoma in Situ / drug therapy. Carcinoma, Squamous Cell / drug therapy. Fingers. Skin Neoplasms / drug therapy
  • [MeSH-minor] Administration, Cutaneous. Aged. Aminoquinolines / administration & dosage. Aminoquinolines / pharmacology. Antimetabolites, Antineoplastic / pharmacology. Cytokines / physiology. Drug Evaluation. Drug Synergism. Fluorouracil / administration & dosage. Fluorouracil / pharmacology. Humans. Male. Middle Aged. Ointments. Prodrugs / pharmacokinetics. Remission Induction. Toll-Like Receptor 7 / antagonists & inhibitors. Toll-Like Receptor 8 / antagonists & inhibitors

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  • (PMID = 17097406.001).
  • [ISSN] 1097-6787
  • [Journal-full-title] Journal of the American Academy of Dermatology
  • [ISO-abbreviation] J. Am. Acad. Dermatol.
  • [Language] eng
  • [Publication-type] Case Reports; Journal Article
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Aminoquinolines; 0 / Antimetabolites, Antineoplastic; 0 / Cytokines; 0 / Ointments; 0 / Prodrugs; 0 / Toll-Like Receptor 7; 0 / Toll-Like Receptor 8; 99011-02-6 / imiquimod; U3P01618RT / Fluorouracil
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99. Kim JC, Steinberg GD: The limits of bacillus Calmette-Guerin for carcinoma in situ of the bladder. J Urol; 2001 Mar;165(3):745-56
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] The limits of bacillus Calmette-Guerin for carcinoma in situ of the bladder.
  • PURPOSE: Historically carcinoma in situ of the bladder has been treated with radical cystectomy based on the aggressive and potentially invasive nature of this disease.
  • The introduction in the late 1970s of intravesical bacillus Calmette-Guerin (BCG) has made this therapy the gold standard in the management of carcinoma in situ.
  • Cases that are refractory or resistant to BCG therapy are a management dilemma with various available treatment options.
  • MATERIALS AND METHODS: A comprehensive literature review of the current management of carcinoma in situ of the bladder was performed using MEDLINE, a review of current urology journals and abstracts from recent urology meetings.
  • Data focused on BCG resistant carcinoma in situ of the bladder and current approaches in use for refractory disease.
  • RESULTS: Complete and durable response rates have been reported in more than 70% of patients with carcinoma in situ who are treated with intravesical BCG.
  • To our knowledge the optimal therapeutic regimen has not been established, although extended periods of treatment beyond the originally described 6-week course have not been shown to improve complete response rates.
  • Various prognostic indicators of recurrence and progression exist that may identify a subset of cases unlikely to respond favorably to a conservative approach, including carcinoma in situ with associated stage T1 bladder lesions, diffuse and multifocal carcinoma in situ, multiple recurrences with intravesical therapy and extravesical involvement.
  • Current molecular markers may also predict the response of carcinoma in situ to therapy.
  • Treatment options available for BCG refractory carcinoma in situ of the bladder include intravesical chemotherapy, combined immuno-chemotherapy and radical cystectomy.
  • Radical cystectomy remains effective therapy for aggressive carcinoma in situ of the bladder.
  • CONCLUSIONS: The current management of carcinoma in situ of the bladder is ill defined due to the variable natural history and unpredictable response of this disease to therapy.
  • Controversy exists as to the optimal treatment of carcinoma in situ of the bladder since different forms of carcinoma in situ may exist that complicate therapeutic decisions for appropriate therapy.
  • Some tumor characteristics are associated with more aggressive behavior and may be predictive of treatment outcome.
  • [MeSH-major] Adjuvants, Immunologic / therapeutic use. BCG Vaccine / therapeutic use. Carcinoma in Situ / drug therapy. Urinary Bladder Neoplasms / drug therapy
  • [MeSH-minor] Algorithms. Biomarkers. Cystectomy. Humans. Prognosis. Treatment Failure

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  • (PMID = 11176460.001).
  • [ISSN] 0022-5347
  • [Journal-full-title] The Journal of urology
  • [ISO-abbreviation] J. Urol.
  • [Language] eng
  • [Publication-type] Journal Article; Research Support, Non-U.S. Gov't; Review
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Adjuvants, Immunologic; 0 / BCG Vaccine; 0 / Biomarkers
  • [Number-of-references] 153
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100. Tamiolakisl D, Venizelos I, Lambropoulou M, Jivannakis T, Seliniotakis E, Tsikouras P, Limberis V, Tsalkidis A, Papadopoulos N: Gains and losses of HLA class II (DR) and CD4 in atypical hyperplasia, carcinoma in situ and infiltrating ductal carcinoma of the breast. Acta Medica (Hradec Kralove); 2004;47(4):257-62
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Gains and losses of HLA class II (DR) and CD4 in atypical hyperplasia, carcinoma in situ and infiltrating ductal carcinoma of the breast.
  • AIM: Breast cancer is a frequent cause of death among women with gynaecologic malignancies despite the introduction of combination chemotherapy.
  • There is therefore a need for new therapeutic strategies for patients with breast cancer, such as cellular immunotherapy.
  • In this immunohistochemical study we analyzed the epithelial expression of major histocompatibility complex (MHC) class II (HLA-DR) on atypical and malignant primary mammary epithelial cells, as well as the magnitude of the stromal T lymphocytes (T4 subset) at the tumor site.
  • EXPERIMENTAL DESIGN: The study was carried out retrospectively in tumor tissue from 82 patients with mammary lesions (31 cases of atypical ductal hyperplasia -ADH-, 12 cases of ductal carcinoma in situ -DCIS- and 39 cases of infiltrating ductal carcinoma not otherwise specified -IDC-NOS).
  • Medullary carcinomas were not included in our investigation.
  • CONCLUSIONS: The results showed decreased epithelial expression of HLA class II (DR) and increased stromal expression of CD4, as the lesion progressed to malignancy.
  • Gradual loss of epithelial HLA class II expression might be a manifestation of cellular differentiation from the atypical form versus the malignant one, signaling simultaneously a selective effect on the response capacity of the immune system.

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  • (PMID = 15844251.001).
  • [ISSN] 1211-4286
  • [Journal-full-title] Acta medica (Hradec Kralove)
  • [ISO-abbreviation] Acta Medica (Hradec Kralove)
  • [Language] ENG
  • [Publication-type] Journal Article
  • [Publication-country] Czech Republic
  • [Chemical-registry-number] 0 / Antigens, CD4; 0 / HLA-DR Antigens
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