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1. Hecht JR, Patnaik A, Berlin J, Venook A, Malik I, Tchekmedyian S, Navale L, Amado RG, Meropol NJ: Panitumumab monotherapy in patients with previously treated metastatic colorectal cancer. Cancer; 2007 Sep 1;110(5):980-8
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  • [Title] Panitumumab monotherapy in patients with previously treated metastatic colorectal cancer.
  • BACKGROUND: The safety and efficacy of the fully human antibody panitumumab was evaluated in patients with metastatic colorectal cancer refractory to available therapies.
  • METHODS: This phase 2 open-label, multicenter study of panitumumab enrolled patients with metastatic colorectal cancer who had progressed on chemotherapy that included a fluoropyrimidine and irinotecan or oxaliplatin, or both.
  • Patients were stratified into 2 strata (high or low staining intensity) and received intravenous panitumumab 2.5 mg/kg weekly 8 of every 9 weeks until disease progression or unacceptable toxicity.
  • RESULTS: In all, 148 patients received panitumumab, 105 in the high EGFr stratum, 43 in the low EGFr stratum.
  • Toxicities were manageable, with skin toxicity reported in 95% of patients (5% grade 3 or 4).
  • Four patients discontinued therapy because of toxicity.
  • One patient had an infusion reaction but was able to continue therapy.
  • CONCLUSIONS: Panitumumab given weekly was well tolerated and had single-agent activity in previously treated patients with colorectal cancer.
  • Ongoing studies will determine panitumumab activity earlier in the course of treatment for colorectal cancer and in combination with other antineoplastic agents.
  • [MeSH-major] Adenocarcinoma / drug therapy. Antibodies, Monoclonal / therapeutic use. Colorectal Neoplasms / drug therapy
  • [MeSH-minor] Adult. Aged. Aged, 80 and over. Antineoplastic Agents / administration & dosage. Antineoplastic Agents / adverse effects. Antineoplastic Agents / therapeutic use. Camptothecin / analogs & derivatives. Camptothecin / therapeutic use. Diarrhea / chemically induced. Drug Administration Schedule. Fatigue / chemically induced. Female. Humans. Immunohistochemistry. Infusions, Intravenous. Male. Middle Aged. Nausea / chemically induced. Neoplasm Metastasis. Organoplatinum Compounds / therapeutic use. Receptor, Epidermal Growth Factor / analysis. Receptor, Epidermal Growth Factor / immunology. Skin Diseases / chemically induced. Survival Analysis. Time Factors. Treatment Outcome

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  • (PMID = 17671985.001).
  • [ISSN] 0008-543X
  • [Journal-full-title] Cancer
  • [ISO-abbreviation] Cancer
  • [Language] eng
  • [Publication-type] Clinical Trial, Phase II; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Antibodies, Monoclonal; 0 / Antineoplastic Agents; 0 / Organoplatinum Compounds; 0 / panitumumab; 04ZR38536J / oxaliplatin; 7673326042 / irinotecan; EC 2.7.10.1 / Receptor, Epidermal Growth Factor; XT3Z54Z28A / Camptothecin
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2. Oliva C, Pochettino P, Bergnolo P, Boglione A, Cutin SC, Inguì M, Dal Canton O, Garetto F, Biscardi M, Berno E, Comandone A, Italian Group for Rare Tumors: Weekly irinotecan plus protracted venous fluorouracil infusion (WI-FI) in advanced colorectal cancer: a phase II study. Anticancer Res; 2008 Jul-Aug;28(4C):2327-32
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  • [Title] Weekly irinotecan plus protracted venous fluorouracil infusion (WI-FI) in advanced colorectal cancer: a phase II study.
  • BACKGROUND: Irinotecan (IRI) is a topoisomerase I inhibitor active as first- or second-line chemotherapy in advanced colorectal cancer (ACRC).
  • In order to identify a new effective and less toxic schedule of administration, we planned this phase II study with weekly IRI and protracted venous infusion of FU (WI-FI regimen).
  • The treatment was repeated every 35 days.
  • Toxicity was low: neutropenia G3 and asthenia G3 were the most observed toxicities (5 pts each).
  • No other grade 3-4 toxic side-effects were seen.
  • CONCLUSION: The WI-FI regimen is an active treatment with a good safety profile in patients with CRC.
  • The low incidence of grade 3-4 toxicities justifies further evaluation of this combination.
  • [MeSH-major] Adenocarcinoma / drug therapy. Antineoplastic Combined Chemotherapy Protocols / administration & dosage. Colorectal Neoplasms / drug therapy
  • [MeSH-minor] Adolescent. Adult. Aged. Camptothecin / administration & dosage. Camptothecin / adverse effects. Camptothecin / analogs & derivatives. Catheterization, Central Venous. Drug Administration Schedule. Female. Fluorouracil / administration & dosage. Fluorouracil / adverse effects. Humans. Infusions, Intravenous. Male. Middle Aged

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  • (PMID = 18751414.001).
  • [ISSN] 0250-7005
  • [Journal-full-title] Anticancer research
  • [ISO-abbreviation] Anticancer Res.
  • [Language] eng
  • [Publication-type] Clinical Trial, Phase II; Journal Article
  • [Publication-country] Greece
  • [Chemical-registry-number] 7673326042 / irinotecan; U3P01618RT / Fluorouracil; XT3Z54Z28A / Camptothecin
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3. Health Quality Ontario: Epidermal Growth Factor Receptor Mutation (EGFR) Testing for Prediction of Response to EGFR-Targeting Tyrosine Kinase Inhibitor (TKI) Drugs in Patients with Advanced Non-Small-Cell Lung Cancer: An Evidence-Based Analysis. Ont Health Technol Assess Ser; 2010;10(24):1-48
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  • [Title] Epidermal Growth Factor Receptor Mutation (EGFR) Testing for Prediction of Response to EGFR-Targeting Tyrosine Kinase Inhibitor (TKI) Drugs in Patients with Advanced Non-Small-Cell Lung Cancer: An Evidence-Based Analysis.
  • Within the PEPP, subgroup committees were developed for each disease area.
  • For each technology, an economic analysis was also completed by the Toronto Health Economics and Technology Assessment Collaborative (THETA) and is summarized within the reports.THE FOLLOWING REPORTS CAN BE PUBLICLY ACCESSED AT THE MAS WEBSITE AT: http://www.health.gov.on.ca/mas or at www.health.gov.on.ca/english/providers/program/mas/mas_about.htmlGENE EXPRESSION PROFILING FOR GUIDING ADJUVANT CHEMOTHERAPY DECISIONS IN WOMEN WITH EARLY BREAST CANCER: An Evidence-Based AnalysisEpidermal Growth Factor Receptor Mutation (EGFR) Testing for Prediction of Response to EGFR-Targeting Tyrosine Kinase Inhibitor (TKI) Drugs in Patients with Advanced Non-Small-Cell Lung Cancer: an Evidence-Based AnalysisK-RAS testing in Treatment Decisions for Advanced Colorectal Cancer: an Evidence-Based Analysis OBJECTIVE: The Medical Advisory Secretariat undertook a systematic review of the evidence on the clinical effectiveness and cost-effectiveness of epidermal growth factor receptor (EGFR) mutation testing compared with no EGFR mutation testing to predict response to tyrosine kinase inhibitors (TKIs), gefitinib (Iressa(®)) or erlotinib (Tarceva(®)) in patients with advanced non-small cell lung cancer (NSCLC).
  • Those with unresectable or advanced disease are commonly treated with concurrent chemoradiation or platinum-based combination chemotherapy.
  • Although response rates to cytotoxic chemotherapy for advanced NSCLC are approximately 30 to 40%, all patients eventually develop resistance and have a median survival of only 8 to 10 months.
  • Treatment for refractory or relapsed disease includes single-agent treatment with docetaxel, pemetrexed or EGFR-targeting TKIs (gefitinib, erlotinib).
  • Gefitinib and erlotinib have been shown to be either non-inferior or superior to chemotherapy in the first- or second-line setting (gefitinib), or superior to placebo in the second- or third-line setting (erlotinib).
  • Certain patient characteristics (adenocarcinoma, non-smoking history, Asian ethnicity, female gender) predict for better survival benefit and response to therapy with TKIs.
  • In addition, the current body of evidence shows that somatic mutations in the EGFR gene are the most robust biomarkers for EGFR-targeting therapy selection.
  • Drugs used in this therapy, however, can be costly, up to C$ 2000 to C$ 3000 per month, and they have only approximately a 10% chance of benefiting unselected patients.
  • Other techniques have been developed for the simple, but highly sensitive detection of specific EGFR mutations, such as the amplification refractory mutations system (ARMS) and the peptide nucleic acid-locked PCR clamping.
  • Others selectively digest wild-type DNA templates with restriction endonucleases to enrich mutant alleles by PCR.
  • RESEARCH QUESTIONS: In patients with locally-advanced or metastatic NSCLC, what is the clinical effectiveness of EGFR mutation testing for prediction of response to treatment with TKIs (gefitinib, erlotinib) in terms of progression-free survival (PFS), objective response rates (ORR), overall survival (OS), and quality of life (QoL)?What is the impact of EGFR mutation testing on overall clinical decision-making for patients with advanced or metastatic NSCLC?What is the cost-effectiveness of EGFR mutation testing in selecting patients with advanced NSCLC for treatment with gefitinib or erlotinib in the first-line setting?What is the budget impact of EGFR mutation testing in selecting patients with advanced NSCLC for treatment with gefitinib or erlotinib in the second- or third-line setting?
  • The quality of evidence was assessed as high, moderate, low or very low according to GRADE methodology.
  • The inclusion criteria were as follows: POPULATION: patients with locally advanced or metastatic NSCLC (stage IIIB or IV)PROCEDURE: EGFR mutation testing before treatment with gefitinib or erlotinibLANGUAGE: publication in EnglishPublished health technology assessments, guidelines, and peer-reviewed literature (abstracts, full text, conference abstract) OUTCOMES: progression-free survival (PFS), Objective response rate (ORR), overall survival (OS), quality of life (QoL).The exclusion criteria were as follows: Studies lacking outcomes specific to those of interestStudies focused on erlotinib maintenance therapyStudies focused on gefitinib or erlotinib use in combination with cytotoxic agents or any other drugGrey literature, where relevant, was also reviewed.
  • OUTCOMES OF INTEREST: PFSORR determined by means of the Response Evaluation Criteria in Solid Tumours (RECIST)OSQoL QUALITY OF EVIDENCE: The quality of the Phase II trials and observational studies was based on the method of subject recruitment and sampling, possibility of selection bias, and generalizability to the source population.
  • The overall quality of evidence was assessed as high, moderate, low or very low according to the GRADE Working Group criteria.
  • SUMMARY OF FINDINGS: Since the last published health technology assessment by Blue Cross Blue Shield Association in 2007 there have been a number of phase III trials which provide evidence of predictive value of EGFR mutation testing in patients who were treated with gefitinib compared to chemotherapy in the first- or second-line setting.
  • The Iressa Pan Asian Study (IPASS) trial showed the superiority of gefitinib in terms of PFS in patients with EGFR mutations versus patients with wild-type EGFR (Hazard ratio [HR], 0.48, 95%CI; 0.36-0.64 versus HR, 2.85; 95%CI, 2.05-3.98).
  • Moreover, there was a statistically significant increased ORR in patients who received gefitinib and had EGFR mutations compared to patients with wild-type EGFR (71% versus 1%).
  • The First-SIGNAL trial in patients with similar clinical characteristics as IPASS as well as the NEJ002 and WJTOG3405 trials that included only patients with EGFR mutations, provide confirmation that gefitinib is superior to chemotherapy in terms of improved PFS or higher ORR in patients with EGFR mutations.
  • The BR.21 trial randomized 731 patients with NSCLC who were refractory or intolerant to prior first- or second-line chemotherapy to receive erlotinib or placebo.

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  • (PMID = 23074402.001).
  • [ISSN] 1915-7398
  • [Journal-full-title] Ontario health technology assessment series
  • [ISO-abbreviation] Ont Health Technol Assess Ser
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] Canada
  • [Other-IDs] NLM/ PMC3377519
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4. Rankovic VI, Masirevic VP, Pavlov MJ, Ceranic MS, Milenkovic MG, Simic AP, Kecmanovic DM: Hemodynamic and cardiovascular problems during modified hyperthermic intraperitoneal perioperative chemotherapy. Hepatogastroenterology; 2007 Mar;54(74):364-6
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  • [Title] Hemodynamic and cardiovascular problems during modified hyperthermic intraperitoneal perioperative chemotherapy.
  • BACKGROUND/AIMS: Cytoreductive surgery and hyperthermic intraperitoneal perioperative chemotherapy (HIPEC) significantly improves patients survival with peritoneal carcinomatosis especially in low-grade tumor e.g. ovarian and appendiceal adenocarcinoma, peritoneal pseudomyxoma and grade I gastric and colorectal cancer.
  • METHODOLOGY: During a period of nine years, hemodynamic and cardiac functions combined with urinary output during hyperthermic intraoperative intraperitoneal chemotherapy were prospectively measured in 60 patients.
  • RESULTS: Statistically significant hemodynamic and cardiac parameters were characterized by an increased heart rate and cardiac output as well as decreased systemic vascular resistance associated with an increased body temperature and decreased effective circulating volume.
  • The tendency of urinary output was to decrease as the therapy progressed.
  • [MeSH-major] Antineoplastic Agents / administration & dosage. Blood Pressure / physiology. Cardiac Output / physiology. Chemotherapy, Cancer, Regional Perfusion / adverse effects. Colorectal Neoplasms / drug therapy. Colorectal Neoplasms / surgery. Heart Rate / physiology. Hyperthermia, Induced / adverse effects. Ovarian Neoplasms / drug therapy. Ovarian Neoplasms / surgery. Peritoneal Neoplasms / drug therapy. Peritoneal Neoplasms / surgery. Postoperative Complications / physiopathology. Pseudomyxoma Peritonei / drug therapy. Pseudomyxoma Peritonei / surgery
  • [MeSH-minor] Blood Volume / physiology. Body Temperature / physiology. Chemotherapy, Adjuvant. Combined Modality Therapy. Electrocardiography. Female. Humans. Male. Vascular Resistance / physiology

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  • (PMID = 17523275.001).
  • [ISSN] 0172-6390
  • [Journal-full-title] Hepato-gastroenterology
  • [ISO-abbreviation] Hepatogastroenterology
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] Greece
  • [Chemical-registry-number] 0 / Antineoplastic Agents
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5. Nozoe Y, Ogata Y, Miyagi Y, Nakagawa M, Matono K, Sasatomi T, Araki Y, Shirouzu K: [Efficacy of postoperative adjuvant chemotherapy for colorectal cancer]. Gan To Kagaku Ryoho; 2002 Jan;29(1):67-72
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  • [Title] [Efficacy of postoperative adjuvant chemotherapy for colorectal cancer].
  • We attempted postoperative adjuvant chemotherapy for stage II or III colorectal cancer.
  • To investigate the efficacy of the adjuvant chemotherapy, we retrospectively reviewed all 293 colorectal cancer patients who underwent curative resection between 1990 and 1996 in Kurume University Hospital.
  • The patients were divided into two groups according to whether or not they received postoperative adjuvant chemotherapy.
  • Findings were similar between the two groups for those with stage II, stage IIIa, a low grade of lymphatic and venous invasion, and well-differentiated adenocarcinoma.
  • Postoperative adjuvant chemotherapy in colorectal cancer might reduce the risk of recurrence, particularly in cases of rectal cancer.
  • However, postoperative adjuvant chemotherapy was insufficient for those with highly advanced cancer or a biologically aggressive tumor.
  • [MeSH-major] Colonic Neoplasms / drug therapy. Rectal Neoplasms / drug therapy
  • [MeSH-minor] Aged. Antibiotics, Antineoplastic / administration & dosage. Antimetabolites, Antineoplastic / administration & dosage. Chemotherapy, Adjuvant. Female. Fluorouracil / administration & dosage. Humans. Male. Middle Aged. Mitomycin / administration & dosage. Postoperative Care. Retrospective Studies. Survival Rate

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  • (PMID = 11816480.001).
  • [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
  • [Publication-country] Japan
  • [Chemical-registry-number] 0 / Antibiotics, Antineoplastic; 0 / Antimetabolites, Antineoplastic; 50SG953SK6 / Mitomycin; U3P01618RT / Fluorouracil
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6. Laudani A, Gebbia V, Leonardi V, Savio G, Borsellino N, Cusimano MP, Calabria C, Stefano R, Agostara B: Activity and toxicity of oxaliplatin plus raltitrexed in 5-fluorouracil refractory metastatic colorectal adeno-carcinoma. Anticancer Res; 2004 Mar-Apr;24(2C):1139-42
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  • [Title] Activity and toxicity of oxaliplatin plus raltitrexed in 5-fluorouracil refractory metastatic colorectal adeno-carcinoma.
  • BACKGROUND: This study evaluated the antitumor efficacy and safety of a novel oxaliplatin/raltitrexed combination in pretreated advanced colorectal cancer patients.
  • PATIENTS AND METHODS: Forty-five patients with 5-fluorouracil-refractory metastatic colorectal cancer received raltitrexed 3.0 mg/m2 as a 15-minute intravenous (i.v.) infusion, followed 45 min later by l-OHP 130 mg/m2 i.v. as 2-h venous infusion on 1 day every 3 weeks.
  • All patients had histologically proven metastatic colorectal cancer, age 18-75, measurable disease and normal baseline biological values.
  • The median time to progression was 4 months (range 1-12+) and median overall survival was 9 months (range 1-29+).
  • CONCLUSION: These data confirm that this oxaliplatin/raltitrexed combination is effective against metastatic colorectal carcinoma, well tolerated with low grade toxicity and easy to administer.
  • [MeSH-major] Adenocarcinoma / drug therapy. Antineoplastic Combined Chemotherapy Protocols / adverse effects. Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Colorectal Neoplasms / drug therapy
  • [MeSH-minor] Adult. Aged. Drug Resistance, Neoplasm. Female. Fluorouracil / administration & dosage. Humans. Leucovorin / administration & dosage. Male. Middle Aged. Neoplasm Metastasis. Organoplatinum Compounds / administration & dosage. Organoplatinum Compounds / adverse effects. Quinazolines / administration & dosage. Quinazolines / adverse effects. Thiophenes / administration & dosage. Thiophenes / adverse effects

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  • (PMID = 15154638.001).
  • [ISSN] 0250-7005
  • [Journal-full-title] Anticancer research
  • [ISO-abbreviation] Anticancer Res.
  • [Language] eng
  • [Publication-type] Clinical Trial; Journal Article
  • [Publication-country] Greece
  • [Chemical-registry-number] 0 / Organoplatinum Compounds; 0 / Quinazolines; 0 / Thiophenes; 04ZR38536J / oxaliplatin; FCB9EGG971 / raltitrexed; Q573I9DVLP / Leucovorin; U3P01618RT / Fluorouracil
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7. Sinicrope F, Foster NR, Sargent DJ, Thibodeau SN, Smyrk TC, O'Connell MJ, North Central Cancer Treatment Group: Model-based prediction of defective DNA mismatch repair using clinicopathological variables in sporadic colon cancer patients. Cancer; 2010 Apr 1;116(7):1691-8
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  • BACKGROUND: : Colon cancers with defective DNA mismatch repair (MMR) have a favorable prognosis and may lack benefit from 5-fluorouracil-based adjuvant chemotherapy.
  • The authors developed models to predict MMR deficiency in sporadic colon cancer patients using routine clinical and pathological data.
  • METHODS: : TNM stage II and III colon carcinomas (n = 982) from 6 5-fluorouracil-based adjuvant therapy trials were analyzed for microsatellite instability and/or MMR protein expression.
  • Tumor site and histologic grade were the most important predictors of MMR status.
  • Distal tumors had a low likelihood of defective MMR (3%; 13 of 468); proximal tumors had a greater likelihood (26%; 130 of 506).
  • By using tumor site, grade, and sex, the logistic regression model showed excellent discrimination (c statistic = 0.81).
  • CONCLUSIONS: : Defective MMR is rare in distal, sporadic colon cancers, which should generally not undergo MMR testing.
  • Proximal site, poor differentiation, and female sex detect 51% of tumors with defective MMR; substituting TILs for grade increases the PPV to 81%.

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  • (PMID = 20186699.001).
  • [ISSN] 0008-543X
  • [Journal-full-title] Cancer
  • [ISO-abbreviation] Cancer
  • [Language] ENG
  • [Grant] United States / NCI NIH HHS / CA / CA15083; United States / NCI NIH HHS / CA / CA104683-02; United States / NCI NIH HHS / CA / P30 CA015083; United States / NCI NIH HHS / CA / R01 CA104683; United States / NCI NIH HHS / CA / K05 CA142885; United States / NCI NIH HHS / CA / R01 CA104683-02; United States / NCI NIH HHS / CA / N01 CA015083
  • [Publication-type] Journal Article; Research Support, N.I.H., Extramural
  • [Publication-country] United States
  • [Other-IDs] NLM/ NIHMS163421; NLM/ PMC2855300
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8. Stratford JK, Bentrem DJ, Anderson JM, Fan C, Volmar KA, Marron JS, Routh ED, Caskey LS, Samuel JC, Der CJ, Thorne LB, Calvo BF, Kim HJ, Talamonti MS, Iacobuzio-Donahue CA, Hollingsworth MA, Perou CM, Yeh JJ: A six-gene signature predicts survival of patients with localized pancreatic ductal adenocarcinoma. PLoS Med; 2010 Jul 13;7(7):e1000307
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] A six-gene signature predicts survival of patients with localized pancreatic ductal adenocarcinoma.
  • BACKGROUND: Pancreatic ductal adenocarcinoma (PDAC) remains a lethal disease.
  • We then applied this cut-point to an independent test set of 67 patients with localized and resected PDAC and found that our signature was independently predictive of survival and superior to established clinical prognostic factors such as grade, tumor size, and nodal status, with a hazard ratio of 4.1 (95% confidence interval [CI] 1.7-10.0).
  • Patients defined to be high-risk patients by the six-gene signature had a 1-year survival rate of 55% compared to 91% in the low-risk group.
  • CONCLUSIONS: Our six-gene signature may be used to better stage PDAC patients and assist in the difficult treatment decisions of surgery and to select patients whose tumor biology may benefit most from neoadjuvant therapy.
  • Genes in this signature, or the pathways that they fall into, may represent new therapeutic targets.

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  • (PMID = 20644708.001).
  • [ISSN] 1549-1676
  • [Journal-full-title] PLoS medicine
  • [ISO-abbreviation] PLoS Med.
  • [Language] ENG
  • [Grant] United States / NIEHS NIH HHS / ES / P30 ES010126; United States / NCI NIH HHS / CA / R01 CA140424; United States / NCI NIH HHS / CA / 5-P50-CA58223-15; United States / NCRR NIH HHS / RR / UL1 RR025741; United States / NCI NIH HHS / CA / P50 CA058223; United States / NCI NIH HHS / CA / K08 CA106610; United States / NCI NIH HHS / CA / T32 CA106610; United States / NCI NIH HHS / CA / P50 CA106991
  • [Publication-type] Evaluation Studies; Journal Article; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't; Validation Studies
  • [Publication-country] United States
  • [Other-IDs] NLM/ PMC2903589
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9. Oñate-Ocaña LF, Montesdeoca R, López-Graniel CM, Aiello-Crocifoglio V, Mondragón-Sánchez R, Cortina-Borja M, Herrera-Goepfert R, Oros-Ovalle C, Gallardo-Rincón D: Identification of patients with high-risk lymph node-negative colorectal cancer and potential benefit from adjuvant chemotherapy. Jpn J Clin Oncol; 2004 Jun;34(6):323-8
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  • [Title] Identification of patients with high-risk lymph node-negative colorectal cancer and potential benefit from adjuvant chemotherapy.
  • BACKGROUND: Adjuvant chemotherapy is not indicated in lymph node-negative colorectal adenocarcinoma (CRC), even though some cases will present recurrent disease.
  • It is important to identify a subgroup of patients with the highest risk of relapse because of the potential benefit of adjuvant chemotherapy.
  • T classification of the primary tumor, differentiation grade, carcinoembryonic antigen level, gender and the presence of neural invasion were significant prognostic factors according to the multivariate analysis (final model P=0.00001).
  • Using risk ratios for these prognostic factors, we defined a high-risk group of 78 patients and a low-risk group of 46 patients with 24 and 5 recurrences, respectively (recurrence rates of 30.8% and 10.9% respectively, P=0.011).
  • CONCLUSIONS: Using these factors, a prognostic scale was developed to predict high risk of recurrence in cases of completely resected CRC and to identify them as a subgroup of patients with potential benefit of adjuvant chemotherapy.
  • [MeSH-major] Adenocarcinoma / drug therapy. Chemotherapy, Adjuvant / methods. Chemotherapy, Adjuvant / nursing. Colorectal Neoplasms / drug therapy
  • [MeSH-minor] Adult. Aged. Cohort Studies. Female. Humans. Lymphatic Metastasis. Male. Middle Aged. Neoplasm Recurrence, Local. Prognosis. Proportional Hazards Models. Retrospective Studies. Time Factors

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  • (PMID = 15333684.001).
  • [ISSN] 0368-2811
  • [Journal-full-title] Japanese journal of clinical oncology
  • [ISO-abbreviation] Jpn. J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] Japan
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10. Méndez M, Alfonso PG, Pujol E, González E, Castañon C, Cerezuela P, López-Mateos Y, Cruz JJ: Weekly irinotecan plus UFT and leucovorin as first-line chemotherapy of patients with advanced colorectal cancer. Invest New Drugs; 2005 Jun;23(3):243-51
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  • [Title] Weekly irinotecan plus UFT and leucovorin as first-line chemotherapy of patients with advanced colorectal cancer.
  • We evaluated the antitumoral efficacy and safety of CPT-11 125 mg/m2 (weekly 90 min i.v. infusion; days 1, 8 and 15) combined with UFT (oral combination of tegafur and uracil) 200 mg/m2/day plus leucovorin (LV) 45 mg/m2/day (both divided into three separate oral doses every 8 h, days 1-21) every 4 weeks as first-line chemotherapy of metastatic colorectal cancer (CRC).
  • The median time to progression and overall survival were 7.9 and 18.2 months, respectively (1-year rate = 74%; 2-years rate = 26%).
  • CPT-11/UFT/LV treatment was well tolerated: the most reported grade 3/4 toxicities were neutropenia (11% of patients) and delayed diarrhea (28% of patients).
  • Weekly CPT-11 plus UFT/LV was found effective and safe as first-line chemotherapy for metastatic CRC.
  • The addition of CPT-11 to UFT/LV doubled the response rate compared to the results previously reported with UFT/LV, while myelosuppression remained low.
  • [MeSH-major] Adenocarcinoma / drug therapy. Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Colorectal Neoplasms / drug therapy
  • [MeSH-minor] Adult. Aged. Aged, 80 and over. Camptothecin / administration & dosage. Camptothecin / analogs & derivatives. Female. Humans. Leucovorin / administration & dosage. Male. Middle Aged. Tegafur / administration & dosage. Tegafur / adverse effects. Tegafur / therapeutic use. Uracil / administration & dosage. Uracil / adverse effects. Uracil / therapeutic use

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  • (PMID = 15868381.001).
  • [ISSN] 0167-6997
  • [Journal-full-title] Investigational new drugs
  • [ISO-abbreviation] Invest New Drugs
  • [Language] eng
  • [Publication-type] Clinical Trial; Clinical Trial, Phase II; Journal Article
  • [Publication-country] United States
  • [Chemical-registry-number] 0H43101T0J / irinotecan; 1548R74NSZ / Tegafur; 56HH86ZVCT / Uracil; Q573I9DVLP / Leucovorin; XT3Z54Z28A / Camptothecin; 1-UFT protocol
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11. Funahashi K, Miki T, Koike J, Washizawa N, Shibata Y, Matsumoto H, Tokuyama T, Ryu M, Shiokawa H, Goto T, Teramoto T: [A case of metastatic liver tumor of colorectal cancer responding to low-dose CPT-11 chemotherapy]. Gan To Kagaku Ryoho; 2003 Mar;30(3):419-21
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  • [Title] [A case of metastatic liver tumor of colorectal cancer responding to low-dose CPT-11 chemotherapy].
  • We report a case in which low-dose CPT-11 chemotherapy was effective for metastatic liver tumor of sigmoid colon cancer.
  • A 49-year-old male with metastatic liver tumor, who had undergone sigmoidectomy with D2 lymphadenectomy, was treated by low-dose CPT-11 chemotherapy (CPT-11 30 mg/m2 x 3 days, every 2 weeks).
  • After 7 courses of this chemotherapy, CT and ultrasound examinations showed a reduction of tumor size in the liver.
  • This chemotherapy also showed no high grade toxicities.
  • Therefore, low-dose CPT-11 chemotherapy seems to be effective for metastatic colorectal cancer, and safe in view of toxicities.
  • [MeSH-major] Adenocarcinoma / drug therapy. Antineoplastic Agents, Phytogenic / administration & dosage. Camptothecin / administration & dosage. Camptothecin / analogs & derivatives. Colorectal Neoplasms / drug therapy. Liver Neoplasms / drug therapy
  • [MeSH-minor] Dose-Response Relationship, Drug. Drug Administration Schedule. Humans. Male. Middle Aged

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  • (PMID = 12669404.001).
  • [ISSN] 0385-0684
  • [Journal-full-title] Gan to kagaku ryoho. Cancer & chemotherapy
  • [ISO-abbreviation] Gan To Kagaku Ryoho
  • [Language] jpn
  • [Publication-type] Case Reports; English Abstract; Journal Article
  • [Publication-country] Japan
  • [Chemical-registry-number] 0 / Antineoplastic Agents, Phytogenic; 7673326042 / irinotecan; XT3Z54Z28A / Camptothecin
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12. Tsuji A, Morita S, Horimi T, Takasaki M, Takahashi I, Shirasaka T: Combination chemotherapy of continuous 5-FU infusion and low-dose cisplatin infusion for the treatment of advanced and recurrent gastric and colorectal adenocarcinomas. Gan To Kagaku Ryoho; 2000 May;27 Suppl 2:528-34
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  • [Title] Combination chemotherapy of continuous 5-FU infusion and low-dose cisplatin infusion for the treatment of advanced and recurrent gastric and colorectal adenocarcinomas.
  • We evaluate the efficacy and toxicities of low-dose FP therapy in the treatment of advanced and recurrent gastric and colorectal adenocarcinomas.
  • 104 patients (gastric adenocarcinoma: 52, colorectal adenocarcinoma: 52) were enrolled.
  • Low-dose FP therapy consisted of 5-FU (160 mg/m2/day every day by continuous infusion) and cisplatin (3 mg/m2/day in 100 ml of normal saline by infusion over 30 minutes on days 1-5/W).
  • Ninety-four of 104 patients completed this therapy, and the treatment accomplishment rate was 90%; 82% in gastric adenocarcinomas, 96% in colorectal adenocarcinomas.
  • Response rates, 50% survival time, 1-year survival rates, and 2-year survival rates were 65.9%, 249 days, 33.7%, 19.7% in gastric adenocarcinomas, and 40.0%, 466 days, 56.7%, 29.4% in colorectal adenocarcinomas, respectively.
  • Nausea/vomiting was the most common toxicity, occurring in 44.2% of patients treated and was predominantly mild to moderate (up to Grade 2).
  • In 5 cases Grade 3 toxicity was observed.
  • Low-dose FP therapy has a high antineoplastic effect and low-grade toxicity, and this therapy should become the first-choice chemotherapy for the treatment of advanced and recurrent gastric and colorectal adenocarcinomas.
  • [MeSH-major] Adenocarcinoma / drug therapy. Antineoplastic Combined Chemotherapy Protocols / administration & dosage. Colorectal Neoplasms / drug therapy. Neoplasm Recurrence, Local / drug therapy. Stomach Neoplasms / drug therapy
  • [MeSH-minor] Adult. Aged. Aged, 80 and over. Cisplatin / administration & dosage. Cisplatin / adverse effects. Drug Administration Schedule. Female. Fluorouracil / administration & dosage. Fluorouracil / adverse effects. Humans. Infusions, Intravenous. Male. Middle Aged. Nausea / chemically induced. Survival Rate. Vomiting, Anticipatory / etiology

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  • (PMID = 10895205.001).
  • [ISSN] 0385-0684
  • [Journal-full-title] Gan to kagaku ryoho. Cancer & chemotherapy
  • [ISO-abbreviation] Gan To Kagaku Ryoho
  • [Language] eng
  • [Publication-type] Clinical Trial; Journal Article
  • [Publication-country] JAPAN
  • [Chemical-registry-number] Q20Q21Q62J / Cisplatin; U3P01618RT / Fluorouracil; CF regimen
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13. Lee JJ, Kim TM, Yu SJ, Kim DW, Joh YH, Oh DY, Kwon JH, Kim TY, Heo DS, Bang YJ, Kim NK: Single-agent capecitabine in patients with metastatic colorectal cancer refractory to 5-fluorouracil/leucovorin chemotherapy. Jpn J Clin Oncol; 2004 Jul;34(7):400-4
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  • [Title] Single-agent capecitabine in patients with metastatic colorectal cancer refractory to 5-fluorouracil/leucovorin chemotherapy.
  • OBJECTIVE: The effectiveness of capecitabine, an oral fluoropyrimidine carbamate, is well documented in previously untreated metastatic colorectal cancer patients (overall response rate: 25%).
  • However, its efficacy in patients with metastatic colorectal cancer refractory to 5-fluorouracil/leucovorin (5-FU/LV) has not been determined.
  • This study was performed to evaluate the efficacy and to identify the side-effects of capecitabine in patients with metastatic colorectal cancer showing progression despite 5-FU/LV-based combination chemotherapy.
  • METHODS: Fifty-one metastatic colorectal cancer patients who showed progressive disease in 5-FU/LV-containing regimens (median: two regimes) were treated with capecitabine 1,250 mg/m(2) twice daily (days 1-14 repeated every 3 weeks).
  • The median time to disease progression of either a partial response or stable disease was 3.4 months.
  • Hand-foot syndrome was the main toxicity of capecitabine and occurred in 35% of cases (grade 3 or 4 in 6%).
  • CONCLUSION: The response rate to capecitabine was low in metastatic colorectal cancers that were refractory to 5-FU/LV-containing chemotherapy.
  • [MeSH-major] Adenocarcinoma / drug therapy. Adenocarcinoma / pathology. Antimetabolites, Antineoplastic / therapeutic use. Colorectal Neoplasms / drug therapy. Colorectal Neoplasms / pathology. Deoxycytidine / analogs & derivatives. Deoxycytidine / therapeutic use. Neoplasm Metastasis
  • [MeSH-minor] Administration, Oral. Adult. Aged. Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Capecitabine. Disease Progression. Drug Resistance, Neoplasm. Female. Fluorouracil / administration & dosage. Humans. Leucovorin / administration & dosage. Male. Middle Aged. Peripheral Nervous System Diseases / chemically induced. Treatment Outcome

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  • (PMID = 15342667.001).
  • [ISSN] 0368-2811
  • [Journal-full-title] Japanese journal of clinical oncology
  • [ISO-abbreviation] Jpn. J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Clinical Trial; Journal Article
  • [Publication-country] Japan
  • [Chemical-registry-number] 0 / Antimetabolites, Antineoplastic; 0W860991D6 / Deoxycytidine; 6804DJ8Z9U / Capecitabine; Q573I9DVLP / Leucovorin; U3P01618RT / Fluorouracil
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14. Shimada S, Yagi Y, Shiomori K, Kuramoto M, Aoki N, Ogawa M: Outpatient therapy with irinotecan and low-dose cisplatin for metastatic colorectal cancer resistant to 5-fluorouracil. Oncol Rep; 2002 Jul-Aug;9(4):783-7
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  • [Title] Outpatient therapy with irinotecan and low-dose cisplatin for metastatic colorectal cancer resistant to 5-fluorouracil.
  • Chemotherapy with irinotecan hydrochloride and low-dose cisplatin was tested for the treatment of metastatic colorectal cancer showing resistance to 5-fluorouracil.
  • Eleven consecutive patients with advanced metastatic colorectal cancer (performance status: 0 to 2), who had shown tumor progression on chemotherapy with 5-fluorouracil/leucovorin, were treated with irinotecan (60 mg/m2) plus cisplatin (6 mg/m2) by 90-min intravenous infusion.
  • Treatment was repeated weekly for 3 weeks during admission and then fortnightly on an outpatient basis.
  • The time to disease progression was longer in the no change group (7.0+/-3.6 months: mean +/- SD) than in the responder group (5.5+/-1.9 months), and there was no difference of median survival between the two groups (10.0 versus 10.3 months).
  • This treatment was well tolerated.
  • Six patients experienced grade 1 or 2 leucopenia, while grade I diarrhea and nausea occurred in three and five patients, respectively.
  • Based on the good response, excellent quality of life, and convenience, the present regimen seems to be reasonable second-line outpatient chemotherapy for patients with metastatic colorectal cancer showing resistance to 5-fluorouracil.
  • [MeSH-major] Adenocarcinoma / drug therapy. Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Camptothecin / analogs & derivatives. Colorectal Neoplasms / drug therapy. Drug Resistance, Neoplasm. Fluorouracil / therapeutic use

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  • (PMID = 12066209.001).
  • [ISSN] 1021-335X
  • [Journal-full-title] Oncology reports
  • [ISO-abbreviation] Oncol. Rep.
  • [Language] eng
  • [Publication-type] Journal Article; Research Support, Non-U.S. Gov't
  • [Publication-country] Greece
  • [Chemical-registry-number] 7673326042 / irinotecan; Q20Q21Q62J / Cisplatin; Q573I9DVLP / Leucovorin; U3P01618RT / Fluorouracil; XT3Z54Z28A / Camptothecin
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15. Yanagisawa Y, Maruta F, Iinuma N, Ishizone S, Koide N, Nakayama J, Miyagawa S: Modified Irinotecan/5FU/Leucovorin therapy in advanced colorectal cancer and predicting therapeutic efficacy by expression of tumor-related enzymes. Scand J Gastroenterol; 2007 Apr;42(4):477-84
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  • [Title] Modified Irinotecan/5FU/Leucovorin therapy in advanced colorectal cancer and predicting therapeutic efficacy by expression of tumor-related enzymes.
  • OBJECTIVE: To evaluate the efficacy and safety of a regimen using Irinotecan, 5FU and Leucovorin for patients with advanced or recurrent colorectal cancer.
  • RESULTS: The 21 consecutive patients subjected to this regimen showed a good response rate (43%) with minimal toxicity (incidence of grade 3/4: leukopenia and neutropenia, 5%, respectively, and vomiting, 10%).
  • The mean survival time of all 21 patients was 15.7 months.
  • This regimen could be a valid option for patients with advanced colorectal cancer, especially those seeking a good QoL (quality of life) for the remainder of their lives.
  • We evaluated the expression of thymidylate synthase (TS), dihydropyrimidine dehydrogenase (DPD), thymidine phosphorylase (TP) and orotate phosphoribosyl transferase (OPRT) mRNAs, and sialyl Lewis X on formalin-fixed, paraffin-embedded colorectal tumor samples.
  • Expression of TS mRNA or sialyl Lewis X was negatively correlated with the response from chemotherapy.
  • Patients with low DPD mRNA expression in the tumor showed a significant longer survival than those with high expression.
  • CONCLUSIONS: Some predictive factors elucidated in this study could contribute to the progress of the tumor-biology based, individualized chemotherapy for colorectal cancer patients.
  • [MeSH-major] Adenocarcinoma / drug therapy. Adenocarcinoma / enzymology. Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Biomarkers, Tumor / analysis. Colorectal Neoplasms / drug therapy. Colorectal Neoplasms / enzymology

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  • (PMID = 17454858.001).
  • [ISSN] 0036-5521
  • [Journal-full-title] Scandinavian journal of gastroenterology
  • [ISO-abbreviation] Scand. J. Gastroenterol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] Norway
  • [Chemical-registry-number] 0 / 5-acetylneuraminyl-(2-3)-galactosyl-(1-4)-(fucopyranosyl-(1-3))-N-acetylglucosamine; 0 / Antigens, CD15; 0 / Antigens, Tumor-Associated, Carbohydrate; 0 / Biomarkers, Tumor; 0 / Oligosaccharides; 0 / ST 439 antigen, human; 12001-76-2 / Vitamin B Complex; 7673326042 / irinotecan; EC 1.3.1.2 / Dihydrouracil Dehydrogenase (NADP); EC 2.1.1.45 / Thymidylate Synthase; EC 2.4.2.10 / Orotate Phosphoribosyltransferase; EC 2.4.2.4 / Thymidine Phosphorylase; Q573I9DVLP / Leucovorin; U3P01618RT / Fluorouracil; XT3Z54Z28A / Camptothecin
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16. Müller H, Nakchbandi V, Chatzisavvidis I, von Voigt C: Repetitive chemoembolization with melphalan plus intra-arterial immuno-chemotherapy within 5-fluorouracil and granulocyte-macrophage colony-stimulating factor (GM-CSF) as effective first- and second-line treatment of disseminated colorectal liver metastases. Hepatogastroenterology; 2003 Nov-Dec;50(54):1919-26
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  • [Title] Repetitive chemoembolization with melphalan plus intra-arterial immuno-chemotherapy within 5-fluorouracil and granulocyte-macrophage colony-stimulating factor (GM-CSF) as effective first- and second-line treatment of disseminated colorectal liver metastases.
  • BACKGROUND/AIMS: In order to improve local and systemic efficacy of chemotherapeutic interventions we have used a combination of high concentrated plus low continuous regional chemotherapy modulated by GM-CSF cytokine in the treatment of inoperable colorectal liver metastases.
  • METHODOLOGY: Sixty-six patients with disseminated inoperable colorectal liver metastases received continuous intra-arterial chemotherapy with 5-FU plus GM-CSF short time application plus chemoembolization Melphalan via an angiographically positioned hepatic artery catheter.
  • Fifty-four percent of these patients had received prior systemic chemotherapy.
  • Side effects were manifested in all patients, mainly upper abdominal pain lasting one to four days and grade 1 or 2 vomiting.
  • Systemic side effects were mild and transient with a very low rate of leukopenia.
  • Time to progression was 8 months.
  • Median survival has not been reached after an observation time of 28 months.
  • There was no statistically significant difference between chemonaive patients and patients pretreated by any kind of systemic therapy.
  • CONCLUSIONS: Repetitive high concentrated regional chemotherapy by use of chemoembolization combined with continuous administered 5-FU and supplemented with GM-CSF is an effective tool in the therapy of disseminated colorectal liver metastases as front line as well as a second-line treatment.
  • [MeSH-major] Adenocarcinoma / secondary. Antimetabolites, Antineoplastic / administration & dosage. Antineoplastic Agents, Alkylating / administration & dosage. Chemoembolization, Therapeutic / methods. Colorectal Neoplasms / therapy. Fluorouracil / administration & dosage. Granulocyte-Macrophage Colony-Stimulating Factor / administration & dosage. Infusions, Intra-Arterial. Liver Neoplasms / secondary. Melphalan / administration & dosage
  • [MeSH-minor] Aged. Combined Modality Therapy. Dose-Response Relationship, Drug. Drug Administration Schedule. Feasibility Studies. Female. Follow-Up Studies. Hepatic Artery. Humans. Leucovorin / administration & dosage. Leucovorin / adverse effects. Male. Middle Aged. Survival Rate. Treatment Outcome

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  • (PMID = 14696433.001).
  • [ISSN] 0172-6390
  • [Journal-full-title] Hepato-gastroenterology
  • [ISO-abbreviation] Hepatogastroenterology
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] Greece
  • [Chemical-registry-number] 0 / Antimetabolites, Antineoplastic; 0 / Antineoplastic Agents, Alkylating; 83869-56-1 / Granulocyte-Macrophage Colony-Stimulating Factor; Q41OR9510P / Melphalan; Q573I9DVLP / Leucovorin; U3P01618RT / Fluorouracil
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17. Hochster H, Chachoua A, Speyer J, Escalon J, Zeleniuch-Jacquotte A, Muggia F: Oxaliplatin with weekly bolus fluorouracil and low-dose leucovorin as first-line therapy for patients with colorectal cancer. J Clin Oncol; 2003 Jul 15;21(14):2703-7
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  • [Title] Oxaliplatin with weekly bolus fluorouracil and low-dose leucovorin as first-line therapy for patients with colorectal cancer.
  • PURPOSE: To determine the activity of biweekly oxaliplatin, combined with weekly bolus fluorouracil (FU) and low-dose leucovorin (LV) chemotherapy (bFOL), as first-line therapy for patients with metastatic colorectal cancer.
  • PATIENTS AND METHODS: Patients with measurable metastatic colorectal cancer; no previous therapy for advanced disease (adjuvant therapy allowed if >6 months since completion); and performance status 0, 1, or 2 were eligible and were treated with oxaliplatin 85 mg/m2 days 1 and 15 plus LV 20 mg/m2 over 10 to 20 minutes, followed by a 500 mg/m2 bolus dose of FU on days 1, 8, and 15 every 28 days.
  • RESULTS: Forty-two patients were entered, and 41 patients were treated, including 20 men and 22 women, nine with previous adjuvant chemotherapy and four with radiation therapy.
  • Major toxicities included cumulative neuropathy grade 2 (24%) and grade 3 (12%; requiring discontinuation of oxaliplatin), diarrhea grade 3 to 4 (29%) and grade 3 to 4 hematologic toxicity (10%).
  • Median time to progression was 9.0 months (95% confidence interval, 7.1 to 10.8 months) with median survival of 15.9 months (95% confidence interval, 11.4 to 19.7 months).
  • [MeSH-major] Adenocarcinoma / drug therapy. Colorectal Neoplasms / drug therapy. Fluorouracil / administration & dosage. Leucovorin / administration & dosage. Organoplatinum Compounds / administration & dosage
  • [MeSH-minor] Adult. Aged. Aged, 80 and over. Antineoplastic Combined Chemotherapy Protocols. Confidence Intervals. Disease-Free Survival. Dose-Response Relationship, Drug. Drug Administration Schedule. Female. Follow-Up Studies. Humans. Male. Middle Aged. Neoplasm Metastasis. Neoplasm Staging. Probability. Remission Induction. Risk Assessment. Survival Rate. Treatment Outcome

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  • (PMID = 12860947.001).
  • [ISSN] 0732-183X
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Grant] United States / NCI NIH HHS / CA / CA16087
  • [Publication-type] Clinical Trial; Clinical Trial, Phase II; Comparative Study; 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 / Organoplatinum Compounds; 04ZR38536J / oxaliplatin; Q573I9DVLP / Leucovorin; U3P01618RT / Fluorouracil
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18. Petrioli R, Bargagli G, Lazzi S, Pascucci A, Francini E, Bellan C, Conca R, Martellucci I, Fiaschi AI, Lorenzi B, Francini G, Multidisciplinary Oncology Group in Gastrointestinal Tumors: Thymidine phosphorylase expression in metastatic sites is predictive for response in patients with colorectal cancer treated with continuous oral capecitabine and biweekly oxaliplatin. Anticancer Drugs; 2010 Mar;21(3):313-9
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  • [Title] Thymidine phosphorylase expression in metastatic sites is predictive for response in patients with colorectal cancer treated with continuous oral capecitabine and biweekly oxaliplatin.
  • The primary objective of this study was to determine the activity and safety profile of biweekly oxaliplatin combined with continuous oral capecitabine in the first-line treatment of metastatic colorectal cancer.
  • A secondary endpoint was to investigate the correlation between thymidylate synthase and thymidine phosphorylase (TP) expression in metastatic tissues and tumor response.
  • There were no grade 4 toxicities, and grade 3 toxicity was also uncommon.
  • High TP expression in metastatic tissue was significantly associated with response to treatment (P=0.019), and also with a trend towards a better median progression-free survival and overall survival compared with patients expressing low TP (P=0.056; P=0.073).
  • This study suggests that biweekly oxaliplatin and continuous oral capecitabine is an active and well-tolerated chemotherapy regimen in the first-line treatment of metastatic colorectal cancer.
  • Moreover, these findings add to a growing body of evidence that patients with high levels of intratumoral TP expression are the ideal candidates for capecitabine-based chemotherapy.
  • [MeSH-major] Antineoplastic Combined Chemotherapy Protocols. Colorectal Neoplasms / drug therapy. Deoxycytidine / analogs & derivatives. Fluorouracil / analogs & derivatives. Organoplatinum Compounds / administration & dosage. Thymidine Phosphorylase / biosynthesis
  • [MeSH-minor] Adenocarcinoma / drug therapy. Adenocarcinoma / enzymology. Aged. Aged, 80 and over. Capecitabine. Drug Administration Schedule. Female. Humans. Longitudinal Studies. Male. Middle Aged. Neoplasm Metastasis. Prognosis. Thymidylate Synthase / biosynthesis

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  • (PMID = 20016369.001).
  • [ISSN] 1473-5741
  • [Journal-full-title] Anti-cancer drugs
  • [ISO-abbreviation] Anticancer Drugs
  • [Language] eng
  • [Publication-type] Clinical Trial; Journal Article
  • [Publication-country] England
  • [Chemical-registry-number] 0 / Organoplatinum Compounds; 04ZR38536J / oxaliplatin; 0W860991D6 / Deoxycytidine; 6804DJ8Z9U / Capecitabine; EC 2.1.1.45 / Thymidylate Synthase; EC 2.4.2.4 / Thymidine Phosphorylase; U3P01618RT / Fluorouracil
  • [Investigator] Bernini A; Civitelli S; Calomino; De Martino A; Tani F; Marzocca G; Lorenzi M; Roviello F; Marrelli D; Intrivici C; Paolelli L; Giusti G
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19. Ohnishi T, Kanoh T, Kimura Y, Iwazawa T, Tono T, Nakano Y, Yano K, Monden T: [Successful low-dose TS-1 administration in an elderly colon cancer patient with liver metastasis]. Gan To Kagaku Ryoho; 2007 Apr;34(4):623-5
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  • [Title] [Successful low-dose TS-1 administration in an elderly colon cancer patient with liver metastasis].
  • TS-1 administration at a dose of 80 mg/day induced grade 3 anorexia, and after complete recovery from the adverse reaction, it was converted to a low-dose TS-1 administration at 40 mg/day.
  • This treatment reduced the diameter of the liver metastasis and was continued for ten months without any adverse reaction.
  • Pharmacokinetic analysis in this patient on low-dose TS-1 showed that Cmax and AUC of 5-chloro-2,4-dihydroxypyridine (CDHP) were equivalent to the values reported in cancer patients with normal renal function receiving standard-dose administration.
  • TS-1 therapy may provide a safe and effective alternative to chemotherapy for elderly patients with advanced colorectal carcinoma.
  • [MeSH-major] Adenocarcinoma / drug therapy. Antimetabolites, Antineoplastic / administration & dosage. Appendiceal Neoplasms / secondary. Colonic Neoplasms / drug therapy. Liver Neoplasms / secondary. Oxonic Acid / administration & dosage. Tegafur / administration & dosage
  • [MeSH-minor] Aged, 80 and over. Dose-Response Relationship, Drug. Drug Administration Schedule. Drug Combinations. Humans. Male

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  • (PMID = 17431353.001).
  • [ISSN] 0385-0684
  • [Journal-full-title] Gan to kagaku ryoho. Cancer & chemotherapy
  • [ISO-abbreviation] Gan To Kagaku Ryoho
  • [Language] jpn
  • [Publication-type] Case Reports; English Abstract; Journal Article
  • [Publication-country] Japan
  • [Chemical-registry-number] 0 / Antimetabolites, Antineoplastic; 0 / Drug Combinations; 150863-82-4 / S 1 (combination); 1548R74NSZ / Tegafur; 5VT6420TIG / Oxonic Acid
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20. Jakobsen A, Mortensen JP, Bisgaard C, Lindebjerg J, Hansen JW, Rafaelsen SR: Preoperative chemoradiation of locally advanced T3 rectal cancer combined with an endorectal boost. Int J Radiat Oncol Biol Phys; 2006 Feb 1;64(2):461-5
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  • PURPOSE: To investigate the effect and feasibility of concurrent radiation and chemotherapy combined with endorectal brachytherapy in T3 rectal cancer with complete pathologic remission as end point.
  • METHODS AND MATERIALS: The study included 50 patients with rectal adenocarcinoma.
  • Clinical target volume 1 (CTV1) received 60 Gy/30 fractions, and CTV2 received 48.6 Gy/27 fractions.
  • The tumor dose was raised to 65 Gy with endorectal brachytherapy 5 Gy/1 fraction to the tumor bed.
  • On treatment days, the patients received uracil and tegafur 300 mg/m2 concurrently with radiotherapy.
  • Histopathologic tumor regression was assessed by the Tumor Regression Grade (TRG) system.
  • The toxicity was low.
  • CONCLUSION: The results indicate that high-dose radiation with concurrent chemotherapy and endorectal brachytherapy is feasible with a high rate of complete response, but further trials are needed to define its possible role as treatment option.
  • [MeSH-major] Adenocarcinoma / drug therapy. Adenocarcinoma / radiotherapy. Brachytherapy / methods. Rectal Neoplasms / drug therapy. Rectal Neoplasms / radiotherapy
  • [MeSH-minor] Antimetabolites, Antineoplastic / therapeutic use. Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Combined Modality Therapy. Feasibility Studies. Female. Fluorouracil / administration & dosage. Humans. Male. Middle Aged. Neoplasm Staging. Radiotherapy Dosage. Remission Induction. Tegafur / administration & dosage

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  • (PMID = 16226396.001).
  • [ISSN] 0360-3016
  • [Journal-full-title] International journal of radiation oncology, biology, physics
  • [ISO-abbreviation] Int. J. Radiat. Oncol. Biol. Phys.
  • [Language] eng
  • [Publication-type] Evaluation Studies; Journal Article
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Antimetabolites, Antineoplastic; 1548R74NSZ / Tegafur; U3P01618RT / Fluorouracil
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21. Shibaki T, Morimoto N: [Advanced rectal cancer in an older patient, in whom metastatic liver lesions were effectively controlled with oral UFT+LV and venous CPT-11 administration--case report]. Gan To Kagaku Ryoho; 2006 Jun;33(6):825-8
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • One month after the operation, adjuvant chemotherapy with oral administration of tegafur/uracil compound (UFT) and Leucovorin (LV), and drip venous infusion of irinotecan hydrochloride (CPT-11) was initiated (UFT 300 mg/day for 14 days, LV 75 mg/day for 14 days, CPT-11 90 mg/m(2) on the 1 st day, with 1 course consisting of 21 days).
  • The levels of tumor markers, CA19-9 and CEA, and the size of metastases on CT were reduced remarkably after one and 4 courses of this therapy, respectively.
  • Although the administration was temporarily discontinued due to low-grade nausea, we continued the treatment.
  • Adjuvant chemotherapy with an oral administering agent is favorable for older patients with advanced colorectal cancer to reduce side effects and preserve the quality of life.
  • [MeSH-major] Adenocarcinoma / drug therapy. Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Liver Neoplasms / secondary. Rectal Neoplasms / drug therapy
  • [MeSH-minor] Administration, Oral. Aged, 80 and over. Camptothecin / administration & dosage. Camptothecin / analogs & derivatives. Colon, Sigmoid / surgery. Colostomy. Drug Administration Schedule. Drug Combinations. Humans. Infusions, Intra-Arterial. Leucovorin / administration & dosage. Male. Omentum / pathology. Peritoneal Neoplasms / secondary. Remission Induction. Tegafur / administration & dosage. Uracil / administration & dosage

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  • (PMID = 16770106.001).
  • [ISSN] 0385-0684
  • [Journal-full-title] Gan to kagaku ryoho. Cancer & chemotherapy
  • [ISO-abbreviation] Gan To Kagaku Ryoho
  • [Language] jpn
  • [Publication-type] Case Reports; English Abstract; Journal Article
  • [Publication-country] Japan
  • [Chemical-registry-number] 0 / Drug Combinations; 0 / UFT(R) drug; 1548R74NSZ / Tegafur; 56HH86ZVCT / Uracil; 7673326042 / irinotecan; Q573I9DVLP / Leucovorin; XT3Z54Z28A / Camptothecin
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22. Chung KY, Kelsen D: Adjuvant Therapy for Stage II Colorectal Cancer: Who and with What? Curr Treat Options Gastroenterol; 2006 Jun;9(3):272-80

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Adjuvant Therapy for Stage II Colorectal Cancer: Who and with What?
  • The role of adjuvant chemotherapy for patients with stage II colon adenocarcinoma remains controversial.
  • The high surgical cure rate for patients with "low-risk" stage II colon cancer, ranging from 75% to 80%, and the available clinical trials and meta-analyses provide conflicting recommendations for or against adjuvant chemotherapy for this group of patients.
  • For fit "high-risk" stage II patients with clinical obstruction or perforation at presentation, in which the 5-year survival rate is 60% to 70%, there is little controversy, as these patients are routinely treated with adjuvant chemotherapy.
  • Other potential high-risk factors, including high histologic grade, microsatellite instability, and loss of 18q, have yet to be validated in prospective trials.
  • These patients may have stage III disease and should receive adjuvant therapy.
  • The decision to use adjuvant chemotherapy to treat low-risk stage II colon cancer patients (no obstruction or perforation) should be an informed decision weighing the magnitude of a net 2% to 5% survival benefit, a 0.5% to 1.0% risk of mortality with chemotherapy in addition to 6 months of chemotherapy-related toxicities, other coexisting patient morbidities, and the anticipated life expectancy of each patient.
  • As adjuvant chemotherapy is therapy addressing local or metastatic microscopic disease, and the effectiveness of systemic and biologically targeted therapy for advanced macroscopic colon cancer continues to improve rapidly, it remains to be determined by clinical trials whether therapies including newer agents such as cetuximab and bevacizumab administered in the adjuvant setting may affect survival for stage II cancer patients.

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  • (PMID = 16901391.001).
  • [ISSN] 1092-8472
  • [Journal-full-title] Current treatment options in gastroenterology
  • [ISO-abbreviation] Curr Treat Options Gastroenterol
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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23. Akasu T, Takawa M, Yamamoto S, Ishiguro S, Yamaguchi T, Fujita S, Moriya Y, Nakanishi Y: Intersphincteric resection for very low rectal adenocarcinoma: univariate and multivariate analyses of risk factors for recurrence. Ann Surg Oncol; 2008 Oct;15(10):2668-76

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Intersphincteric resection for very low rectal adenocarcinoma: univariate and multivariate analyses of risk factors for recurrence.
  • BACKGROUND: The aim of this study was to analyze the risk factors for local and distant recurrence after intersphincteric resection (ISR) for very low rectal adenocarcinoma.
  • RESULTS: Fifty patients had disease categorized as stage I, 21 as stage II, 46 as stage III, and 3 as stage IV on the basis of International Union Against Cancer tumor, node, metastasis staging system.
  • Median follow-up time was 3.5 years.
  • Univariate analysis of the risk factors for distant recurrence indicated tumor location, combined resection, tumor annularity, pathologic N, lateral pelvic lymph node metastasis, pathologic stage, histologic grade, lymphovascular invasion, perineural invasion, and adjuvant chemotherapy to be significant.
  • Multivariate analysis identified pathologic N, histologic grade, and tumor location to be independently significant.
  • For distant recurrence, the lymph node status, histologic grade, and tumor location need to be taken into account.
  • [MeSH-major] Adenocarcinoma / surgery. Anal Canal / surgery. Neoplasm Recurrence, Local / diagnosis. Rectal Neoplasms / surgery
  • [MeSH-minor] Adult. Aged. CA-19-9 Antigen / blood. Disease-Free Survival. Female. Follow-Up Studies. Humans. Lymph Nodes / pathology. Lymph Nodes / surgery. Lymphatic Metastasis. Male. Middle Aged. Neoplasm Staging. Prospective Studies. Retrospective Studies. Risk Factors. Survival Rate. Treatment Outcome

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  • (PMID = 18618181.001).
  • [ISSN] 1534-4681
  • [Journal-full-title] Annals of surgical oncology
  • [ISO-abbreviation] Ann. Surg. Oncol.
  • [Language] eng
  • [Publication-type] Comparative Study; Journal Article; Research Support, Non-U.S. Gov't
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / CA-19-9 Antigen
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24. Jantscheff P, Terracciano L, Lowy A, Glatz-Krieger K, Grunert F, Micheel B, Brümmer J, Laffer U, Metzger U, Herrmann R, Rochlitz C: Expression of CEACAM6 in resectable colorectal cancer: a factor of independent prognostic significance. J Clin Oncol; 2003 Oct 1;21(19):3638-46
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Expression of CEACAM6 in resectable colorectal cancer: a factor of independent prognostic significance.
  • PURPOSE: CEACAM6, CEACAM1, and human carcinoembryonic antigen (CEA) are coexpressed in normal colorectal epithelia, but show deregulated expression in colorectal cancers (CRC).
  • Upregulation of CEACAM6 expression in hyperplastic polyps and early adenomas represents one of the earliest observable molecular events leading to colorectal tumors.
  • The aim of our study was to evaluate the prognostic relevance of CEACAM6, CEACAM1, and CEA tissue expression in patients with CRC.
  • PATIENTS AND METHODS: Immunohistochemical analysis was carried out on tissue microarrays from 243 paraffin-embedded biopsies from a randomized controlled clinical trial (Swiss Group for Clinical Cancer Research [SAKK] 40/81) of adjuvant fluorouracil-based chemotherapy with CEACAM-specific monoclonal antibodies.
  • RESULTS: Tissue expression of CEACAM6, CEACAM1, and CEA was enhanced in 55%, 58%, and 94% of patients, respectively.
  • Multivariate Cox analysis including sex, age, tumor site, stage, differentiation grade, treatment, and nodal status as covariates showed that CEACAM6 overexpression independently predicted poor OS (HR, 1.86; P =.0100) and DFS (HR, 2.00; P =.0028), whereas CEACAM1 or CEA were not significantly related to these outcomes.
  • The data did not provide evidence for or against the hypothesis that the CEACAM6 effect on survival differs according to treatment.
  • CONCLUSION: Expression of the cell adhesion molecule CEACAM6 in CRC is an independent prognostic factor allowing subdivision of patients into low- and high-risk groups.
  • Whether CEACAM6 or CEA and CEACAM1 might be useful as predictive markers of chemotherapy benefit remains unclear.
  • [MeSH-major] Adenocarcinoma / genetics. Adenocarcinoma / pathology. Antigens, Neoplasm / biosynthesis. Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Cell Adhesion Molecules / biosynthesis. Colorectal Neoplasms / genetics. Colorectal Neoplasms / pathology. Gene Expression Regulation, Neoplastic. Genetic Markers

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  • (PMID = 14512395.001).
  • [ISSN] 0732-183X
  • [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; Research Support, Non-U.S. Gov't
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Antigens, CD; 0 / Antigens, Differentiation, Myelomonocytic; 0 / Antigens, Neoplasm; 0 / CEACAM6 protein, human; 0 / Cell Adhesion Molecules; 0 / GPI-Linked Proteins; 0 / Genetic Markers; U3P01618RT / Fluorouracil
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25. Bruin SC, Verwaal VJ, Vincent A, van't Veer LJ, van Velthuysen ML: A clinicopathologic analysis of peritoneal metastases of colorectal and appendiceal origin. Ann Surg Oncol; 2010 Sep;17(9):2330-40
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] A clinicopathologic analysis of peritoneal metastases of colorectal and appendiceal origin.
  • OBJECTIVE: To predict clinical outcome by classification of peritoneal metastases (PM) of colorectal or appendiceal origin.
  • BACKGROUND: This study investigates whether standardized histological classification can predict outcome for PM of colorectal or appendiceal origin treated with cytoreduction and hyperthermic intraperitoneal chemotherapy (HIPEC).
  • Covariates included tumor, patient, and treatment characteristics.
  • RESULTS: PM could be categorized into four groups: low-grade, well-differentiated mucinous tumor (DPAM); intermediated-grade mucinous carcinoma (PMCA-i); high-grade mucinous carcinoma (PMCA); and high-grade nonmucinous carcinoma (PCA).
  • Multivariate analysis showed that histological classification, gender, number of segments affected, completeness of cytoreduction, and HIPEC as primary treatment were significant related to OS and DFS.
  • Of PM originating from an appendix tumor, 29% were of non-DPAM type.
  • Of primary colorectal tumors, 37% resulted in mucinous PM, and another 26% of PM of colorectal origin had partly mucinous histology.
  • Low-grade PM (DPAM) should be regarded as a separate entity because of its clearly different clinical course.
  • High-grade mucinous PM has significant better prognosis than nonmucinous PM and should thus be distinguished.
  • [MeSH-major] Adenocarcinoma, Mucinous / secondary. Appendiceal Neoplasms / pathology. Colorectal Neoplasms / pathology. Peritoneal Neoplasms / secondary
  • [MeSH-minor] Aged. Combined Modality Therapy. Female. Humans. Male. Middle Aged. Neoplasm Staging. Prognosis. Survival Rate

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  • (PMID = 20232161.001).
  • [ISSN] 1534-4681
  • [Journal-full-title] Annals of surgical oncology
  • [ISO-abbreviation] Ann. Surg. Oncol.
  • [Language] eng
  • [Publication-type] Clinical Trial; Journal Article
  • [Publication-country] United States
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26. Myerson RJ, Singh A, Birnbaum EH, Fry RD, Fleshman JW, Kodner IJ, Lockett MA, Picus J, Walz BJ, Read TE: Pretreatment clinical findings predict outcome for patients receiving preoperative radiation for rectal cancer. Int J Radiat Oncol Biol Phys; 2001 Jul 1;50(3):665-74
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • BACKGROUND: As a sole modality, preoperative radiation for rectal carcinoma achieves a local control comparable to that of postoperative radiation plus chemotherapy.
  • Although the addition of chemotherapy to preoperative treatment improves the pathologic complete response rate, there is also a substantial increase in acute and perioperative morbidity.
  • Identification of subsets of patients who are at low or high risk for recurrence can help to optimize treatment.
  • METHODS: During the period 1977-95, 384 patients received preoperative radiation therapy for localized adenocarcinoma of the rectum.
  • Preoperative treatment consisted of conventionally fractionated radiation to 3600-5040 cGy (median 4500 cGy) 6-8 weeks before surgery in 293 cases or low doses of <3000 cGy (median 2000 cGy) immediately before surgery in 91 cases.
  • Concurrent preoperative chemotherapy was given to only 14 cases in this study period.
  • Postoperative chemotherapy was delivered to 55 cases.
  • Local failures were scored if they occurred at any time, not just as first site of failure.
  • Size, grade, age, gender, ultrasound stage, CEA, radiation dose, and the use of chemotherapy were not associated with outcome.
  • Background of the surgeon was significantly associated with outcome, colorectal specialists achieving better results than nonspecialist surgeons.
  • For colorectal specialists (251 cases), the 5-year LC is 100%, 94%, and 78% for scores of 0, 1, and 2, respectively (p = 0.004).
  • CONCLUSIONS: For many patients with rectal cancer, adjuvant treatment can be administered in a well-tolerated sequential fashion-moderate doses of preoperative radiation followed by surgery followed by postoperative chemotherapy to address the risk of occult metastatic disease.
  • A clinical scoring system has been presented here that would suggest that the local control is excellent for lesions with a score of 0 or (if the surgeon is experienced) 1, and therefore sequential treatment could be considered.
  • Cases with a clinical score of 2 should be strongly considered for protocols evaluating more aggressive preoperative treatment, such as combined modality preoperative treatment.
  • [MeSH-major] Adenocarcinoma / radiotherapy. Rectal Neoplasms / radiotherapy
  • [MeSH-minor] Adult. Aged. Aged, 80 and over. Analysis of Variance. Combined Modality Therapy. Disease-Free Survival. Female. Humans. Intraoperative Care. Male. Middle Aged. Neoplasm Recurrence, Local. Neoplasm Staging. Predictive Value of Tests. Risk Factors. Treatment Outcome

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  • (PMID = 11395234.001).
  • [ISSN] 0360-3016
  • [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
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27. Sasaki K, Takasaka H, Kawasaki H, Matsunaga T, Nakagawa N, Shibata K, Yabana T, Yasojima T, Furuhata T, Hata F, Hirata K: [Weekly low-dose CPT-11 and HCFU for advanced colorectal cancer on an outpatient treatment basis]. Gan To Kagaku Ryoho; 2000 Jun;27(6):915-9
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] [Weekly low-dose CPT-11 and HCFU for advanced colorectal cancer on an outpatient treatment basis].
  • We attempted a new outpatient treatment using weekly low-dose CPT-11 for advanced colorectal cancer patients.
  • A 73-year-old female with para-aortic lymph node metastases from advanced rectal cancer was given outpatient treatment for more than 5 months with weekly low-dose CPT-11 and HCFU.
  • There were no adverse effects except leukopenia (grade 2).
  • These results suggest that weekly low-dose CPT-11 and oral HCFU may be an effective therapy on an outpatient basis in cases of advanced colorectal cancer.
  • [MeSH-major] Adenocarcinoma / drug therapy. Ambulatory Care. Antineoplastic Combined Chemotherapy Protocols / administration & dosage. Colorectal Neoplasms / drug therapy
  • [MeSH-minor] Administration, Oral. Aged. Camptothecin / administration & dosage. Camptothecin / analogs & derivatives. Drug Administration Schedule. Female. Fluorouracil / administration & dosage. Fluorouracil / analogs & derivatives. Humans. Infusions, Intravenous. Lymph Node Excision. Lymphatic Metastasis

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  • (PMID = 10897221.001).
  • [ISSN] 0385-0684
  • [Journal-full-title] Gan to kagaku ryoho. Cancer & chemotherapy
  • [ISO-abbreviation] Gan To Kagaku Ryoho
  • [Language] jpn
  • [Publication-type] Case Reports; English Abstract; Journal Article
  • [Publication-country] JAPAN
  • [Chemical-registry-number] 7673326042 / irinotecan; HA82M3RAB2 / 1-hexylcarbamoyl-5-fluorouracil; U3P01618RT / Fluorouracil; XT3Z54Z28A / Camptothecin
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28. Yamaguchi Y, Sawamura A, Minami K: Clinical trial of low-dose leucovorin plus 5-fluorouracil for patients with metastatic colorectal cancer. Hepatogastroenterology; 2007 Jul-Aug;54(77):1394-7
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Clinical trial of low-dose leucovorin plus 5-fluorouracil for patients with metastatic colorectal cancer.
  • BACKGROUND/AIMS: To establish an effective and practical treatment of Japanese patients with metastatic colorectal cancer in an outpatient setting, we conducted a clinical trial using a modified Mayo regimen.
  • METHODOLOGY: A bolus injection of low-dose (20 mg/m2) d,l-leucovorin (LV) was administered, followed one hour later by an intravenous injection of 333 mg/m2 5-fluorouracil (5-FU) for another hour.
  • The two drugs were given on days 1, 2, and 3, and the treatment was repeated every 2 weeks.
  • RESULTS: In the 17 patients enrolled in the study, the tumor response rate was 25%, and time-to-treatment failure and median survival time were 7 and 24 months, respectively.
  • The treatment was well tolerated, with no adverse effects greater than grade 3, and could be completed in all patients in the outpatient setting.
  • CONCLUSIONS: These results suggest that although the sample size studied was too small to allow us to draw definitive conclusions, this regimen may be an effective and practical alternative to the Mayo regimen in an outpatient setting for Japanese patients with metastatic colorectal cancer.
  • [MeSH-major] Adenocarcinoma / drug therapy. Adenocarcinoma / pathology. Antimetabolites, Antineoplastic / therapeutic use. Colorectal Neoplasms / drug therapy. Colorectal Neoplasms / pathology. Fluorouracil / therapeutic use. Leucovorin / administration & dosage. Vitamin B Complex / administration & dosage
  • [MeSH-minor] Aged. Drug Therapy, Combination. Female. Humans. Male. Middle Aged

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  • (PMID = 17708262.001).
  • [ISSN] 0172-6390
  • [Journal-full-title] Hepato-gastroenterology
  • [ISO-abbreviation] Hepatogastroenterology
  • [Language] eng
  • [Publication-type] Case Reports; Clinical Trial; Journal Article
  • [Publication-country] Greece
  • [Chemical-registry-number] 0 / Antimetabolites, Antineoplastic; 12001-76-2 / Vitamin B Complex; Q573I9DVLP / Leucovorin; U3P01618RT / Fluorouracil
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29. Cassinello J, Alvarez JV, López MJ, Pujol E, Colmenarejo A, Segovia F, Marcos F, Filipovich E, Arcediano A, Castro IG: Multicenter phase II study of fixed sequences of capecitabine combined with oxaliplatin or irinotecan in patients with previously untreated metastatic colorectal cancer. Clin Colorectal Cancer; 2006 Mar;5(6):429-35
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Multicenter phase II study of fixed sequences of capecitabine combined with oxaliplatin or irinotecan in patients with previously untreated metastatic colorectal cancer.
  • PURPOSE: The purpose of this study was to evaluate the antitumor activity and toxicity of fixed sequences of capecitabine/oxaliplatin followed by capecitabine/irinotecan in patients with previously untreated metastatic colorectal cancer.
  • PATIENTS AND METHODS: Adult patients with histologically confirmed, previously untreated, nonresectable, locally advanced or metastatic colorectal adenocarcinoma were enrolled in the study.
  • With a median follow-up of 9.5 months, the median time to disease progression and overall survival were 7.4 months and 16.4 months, respectively.
  • Treatment was well tolerated, with only 6% of the patients developing grade 3/4 neurotoxicity.
  • However, the low number of patients treated beyond 4 cycles limits the interpretation of the data.
  • [MeSH-major] Adenocarcinoma / drug therapy. Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Colorectal Neoplasms / drug therapy
  • [MeSH-minor] Adult. Aged. Camptothecin / administration & dosage. Camptothecin / analogs & derivatives. Capecitabine. Deoxycytidine / administration & dosage. Deoxycytidine / analogs & derivatives. Disease-Free Survival. Dose-Response Relationship, Drug. Drug Administration Schedule. Drug-Related Side Effects and Adverse Reactions. Female. Fluorouracil / analogs & derivatives. Humans. Male. Middle Aged. Organoplatinum Compounds / administration & dosage. Survival Rate

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  • (PMID = 16635282.001).
  • [ISSN] 1533-0028
  • [Journal-full-title] Clinical colorectal cancer
  • [ISO-abbreviation] Clin Colorectal Cancer
  • [Language] eng
  • [Publication-type] Clinical Trial, Phase II; Journal Article; Multicenter Study
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Organoplatinum Compounds; 04ZR38536J / oxaliplatin; 0H43101T0J / irinotecan; 0W860991D6 / Deoxycytidine; 6804DJ8Z9U / Capecitabine; U3P01618RT / Fluorouracil; XT3Z54Z28A / Camptothecin
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30. Cassinello J, Escudero P, Salud A, Marcos F, Pujol E, Pérez-Carrión R, Colmenarejo A, González del Val R, Valero J, Oruezábal MJ, Guillem V, García I, Arcediano A, Marfà X: Activity and safety of oxaliplatin with weekly 5-fluorouracil bolus and low-dose leucovorin as first-line treatment for advanced colorectal cancer. Clin Colorectal Cancer; 2003 Aug;3(2):108-12
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Activity and safety of oxaliplatin with weekly 5-fluorouracil bolus and low-dose leucovorin as first-line treatment for advanced colorectal cancer.
  • This study was designed to evaluate the safety and tolerability of oxaliplatin combined with weekly boluses of 5-fluorouracil (5-FU) and low doses of leucovorin (LV) and to determine objective response, progression-free survival, and overall survival of patients with previously untreated advanced colorectal cancer.
  • Seventy-nine patients enrolled in an observational, multicenter, prospective, open-label phase II study received intravenous (I.V.) infusions of oxaliplatin 85 mg/m2 over the course of 2 hours on days 1 and 14 and LV 20 mg/m2 over the course of 2 hours and 5-FU 500 mg/m2 as a bolus on days 1, 7, and 14 every 4 weeks until disease progression or unacceptable toxicity occurred.
  • The median time to progression was 7.13 months (range, 6.28-7.72 months), and median overall survival time was 15 months (range, 12.32-18.37 months).
  • Acute dose-limiting toxicities were grade 3/4 diarrhea and neutropenia, which occurred in 10.5% and 3.9% of patients, respectively.
  • Among the 70 patients who experienced neurosensory toxicity, it was estimated that only 1.3% had grade 3 symptoms.
  • [MeSH-major] Adenocarcinoma / drug therapy. Antineoplastic Agents / pharmacology. Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Colorectal Neoplasms / drug therapy. Organoplatinum Compounds / pharmacology
  • [MeSH-minor] Adult. Aged. Diarrhea / chemically induced. Disease Progression. Drug Administration Schedule. Female. Fluorouracil / administration & dosage. Humans. Infusions, Intravenous. Injections, Intravenous. Leucovorin / administration & dosage. Male. Middle Aged. Neutropenia / chemically induced. Treatment Outcome

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  • (PMID = 12952567.001).
  • [ISSN] 1533-0028
  • [Journal-full-title] Clinical colorectal cancer
  • [ISO-abbreviation] Clin Colorectal Cancer
  • [Language] eng
  • [Publication-type] Clinical Trial; Clinical Trial, Phase II; Journal Article
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Antineoplastic Agents; 0 / Organoplatinum Compounds; 04ZR38536J / oxaliplatin; Q573I9DVLP / Leucovorin; U3P01618RT / Fluorouracil
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31. Luna-Pérez P, Rodríguez-Ramírez S, Rodriguez-Coria DF, Fernández A, Labastida S, Silva A, López MJ: Preoperative chemoradiation therapy and anal sphincter preservation with locally advanced rectal adenocarcinoma. World J Surg; 2001 Aug;25(8):1006-11

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Preoperative chemoradiation therapy and anal sphincter preservation with locally advanced rectal adenocarcinoma.
  • Preoperative irradiation has been used to produce tumor regression and allow complete resection of rectal cancer with a sphincter-saving procedure.
  • To evaluate the associated toxicity, the response in the primary tumor, and the postsurgical morbidity in a group of patients with locally advanced rectal cancer treated with preoperative chemoradiation therapy and low anterior resection, 120 patients were treated with 45 Gy of preoperative radiotherapy and a bolus infusion of 5-fluorouracil 450 mg/m2 on days 1 to 5 and 28 to 32 of radiotherapy.
  • Four to six weeks later, 16 lesions were found unresectable; 36 patients underwent abdominoperineal resection or pelvic exenteration, and in the remaining 68 a low anterior resection was performed.
  • Gastrointestinal and hematologic acute toxicity grade 3 to 4 occurred in 12 and 7 patients, respectively.
  • The postsurgical stages were as follows: no tumor in the specimen, 17 (25%); T1, 4 (6%); T2, 12 (17%); T3, 17 (25%); T4, 5 (7%); any T with N+, 9 (13%); and any T, N with M+, 4 (6%).
  • The administration of preoperative chemoradiation therapy for locally advanced rectal cancer is associated with tolerable toxicity, a high rate of response in the primary tumor that allowed anal sphincter preservation, and a low rate of local recurrence.
  • [MeSH-major] Adenocarcinoma / drug therapy. Adenocarcinoma / radiotherapy. Rectal Neoplasms / drug therapy. Rectal Neoplasms / radiotherapy
  • [MeSH-minor] Anal Canal. Combined Modality Therapy. Digestive System Surgical Procedures / methods. Female. Humans. Male. Middle Aged. Preoperative Care

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  • (PMID = 11571965.001).
  • [ISSN] 0364-2313
  • [Journal-full-title] World journal of surgery
  • [ISO-abbreviation] World J Surg
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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32. Glimelius B, Ristamäki R, Kjaer M, Pfeiffer P, Skovsgaard T, Tveit KM, Linné T, Frödin JE, Boussard B, Oulid-Aïssa D, Pyrhönen S: Irinotecan combined with bolus 5-fluorouracil and folinic acid Nordic schedule as first-line therapy in advanced colorectal cancer. Ann Oncol; 2002 Dec;13(12):1868-73
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Irinotecan combined with bolus 5-fluorouracil and folinic acid Nordic schedule as first-line therapy in advanced colorectal cancer.
  • BACKGROUND: This multicentre phase II study evaluated the efficacy and safety of irinotecan combined with the Nordic schedule of 5-fluorouracil (5-FU) and folinic acid (FA) as first-line therapy in patients with advanced colorectal cancer.
  • The estimated median time to progression and survival were 6.4 months (95% CI 5.4-9.0) and 15.6 months (95% CI 13.3-19.0), respectively, in the intention-to-treat population.
  • Neutropenia was the main adverse event with grade 3-4 toxicity in 66% of patients and 17.5% of cycles.
  • Grade 3-4 non-haematological toxicities were infrequent and included diarrhoea in 16% of patients and 2% of cycles and nausea/vomiting in 10% of patients and 1% of cycles.
  • CONCLUSIONS: Irinotecan combined with the bolus Nordic schedule of 5-FU/FA is active in advanced colorectal cancer with an easily managed safety profile which ensures good schedule compliance.
  • The low incidence of grade 3-4 non-haematological toxicity justifies the further evaluation of this combination in the context of randomised clinical trials.

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  • (PMID = 12453854.001).
  • [ISSN] 0923-7534
  • [Journal-full-title] Annals of oncology : official journal of the European Society for Medical Oncology
  • [ISO-abbreviation] Ann. Oncol.
  • [Language] ENG
  • [Publication-type] Clinical Trial; Clinical Trial, Phase II; Comparative Study; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't
  • [Publication-country] England
  • [Chemical-registry-number] 7673326042 / irinotecan; Q573I9DVLP / Leucovorin; U3P01618RT / Fluorouracil; XT3Z54Z28A / Camptothecin
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33. Elshazly WG, Farouk M, Samy M: Preoperative concomitant radiotherapy with oral capecitabine in advanced rectal cancer within 6 cm from anal verge. Int J Colorectal Dis; 2009 Apr;24(4):401-7
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • AIM: This study aimed to evaluate the role preoperative chemo-radiotherapy with oral capacitabine for advanced low rectal cancer within 6 cm of anal verge.
  • PATIENTS AND METHODS: Twenty-six patients with rectal adenocarcinoma were treated with preoperative radiotherapy, and oral capecitabine administrated at 5 days/week.
  • RESULTS: Oral capecitabine was well tolerated in all patients; grade 3 toxicity was seen in only one patient (3.85%) in the form of febrile neutropenia, and diarrhea.
  • Combining such a regimen with intersphincteric resection led to the achievement of distal and radial negative margins, allowing a low local recurrence rate.
  • [MeSH-major] Anal Canal / pathology. Antimetabolites, Antineoplastic / therapeutic use. Deoxycytidine / analogs & derivatives. Fluorouracil / analogs & derivatives. Preoperative Care. Rectal Neoplasms / drug therapy. Rectal Neoplasms / radiotherapy
  • [MeSH-minor] Administration, Oral. Adult. Capecitabine. Combined Modality Therapy. Female. Humans. Male. Middle Aged. Neoplasm Staging. Patient Compliance. Survival Analysis. Treatment Outcome

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  • (PMID = 19084971.001).
  • [ISSN] 1432-1262
  • [Journal-full-title] International journal of colorectal disease
  • [ISO-abbreviation] Int J Colorectal Dis
  • [Language] eng
  • [Publication-type] Clinical Trial; Journal Article; Research Support, Non-U.S. Gov't
  • [Publication-country] Germany
  • [Chemical-registry-number] 0 / Antimetabolites, Antineoplastic; 0W860991D6 / Deoxycytidine; 6804DJ8Z9U / Capecitabine; U3P01618RT / Fluorouracil
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34. Hospers GA, Punt CJ, Tesselaar ME, Cats A, Havenga K, Leer JW, Marijnen CA, Jansen EP, Van Krieken HH, Wiggers T, Van de Velde CJ, Mulder NH: Preoperative chemoradiotherapy with capecitabine and oxaliplatin in locally advanced rectal cancer. A phase I-II multicenter study of the Dutch Colorectal Cancer Group. Ann Surg Oncol; 2007 Oct;14(10):2773-9
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Preoperative chemoradiotherapy with capecitabine and oxaliplatin in locally advanced rectal cancer. A phase I-II multicenter study of the Dutch Colorectal Cancer Group.
  • BACKGROUND: We studied the maximum tolerated dose (MTD) and efficacy of oxaliplatin added to capecitabine and radiotherapy (Capox-RT) as neoadjuvant therapy for rectal cancer.
  • METHODS: T3-4 rectal cancer patients received escalating doses of oxaliplatin (day 1 and 29) with a fixed dose of capecitabine of 1000 mg/m(2) twice daily (days 1-14, 25-38) added to RT with 50.4 Gy and surgery after 6-8 weeks.
  • The MTD, determined during phase I, was used in the subsequent phase II, in which R0 resection rate (a negative circumferential resection margin) was the primary end point.
  • In phase II, the main toxicity was grade III diarrhea (18%).
  • However the pCR rate was low.
  • [MeSH-major] Adenocarcinoma / drug therapy. Adenocarcinoma / radiotherapy. Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Neoadjuvant Therapy. Rectal Neoplasms / drug therapy. Rectal Neoplasms / radiotherapy
  • [MeSH-minor] Adult. Aged. Capecitabine. Deoxycytidine / administration & dosage. Deoxycytidine / analogs & derivatives. Deoxycytidine / toxicity. Dose-Response Relationship, Drug. Drug Administration Schedule. Female. Fluorouracil / administration & dosage. Fluorouracil / analogs & derivatives. Fluorouracil / toxicity. Humans. Male. Maximum Tolerated Dose. Middle Aged. Neoplasm Staging. Organoplatinum Compounds / administration & dosage. Organoplatinum Compounds / toxicity. Pain Measurement. Particle Accelerators. Quality of Life. Radiotherapy Dosage. Rectum / pathology. Rectum / surgery

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  • (PMID = 17653805.001).
  • [ISSN] 1068-9265
  • [Journal-full-title] Annals of surgical oncology
  • [ISO-abbreviation] Ann. Surg. Oncol.
  • [Language] eng
  • [Publication-type] Clinical Trial, Phase I; Clinical Trial, Phase II; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Organoplatinum Compounds; 04ZR38536J / oxaliplatin; 0W860991D6 / Deoxycytidine; 6804DJ8Z9U / Capecitabine; U3P01618RT / Fluorouracil
  • [Other-IDs] NLM/ PMC2039827
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35. Carraro S, Roca EL, Cartelli C, Rafailovici L, Castillo Odena S, Wasserman E, Gualdrini U, Huertas E, Barugel M, Ballarino G, Rodriguez MC, Masciangioli G: Radiochemotherapy with short daily infusion of low-dose oxaliplatin, leucovorin, and 5-FU in T3-T4 unresectable rectal cancer: a phase II IATTGI study. Int J Radiat Oncol Biol Phys; 2002 Oct 1;54(2):397-402
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  • [Title] Radiochemotherapy with short daily infusion of low-dose oxaliplatin, leucovorin, and 5-FU in T3-T4 unresectable rectal cancer: a phase II IATTGI study.
  • PURPOSE: Oxaliplatin (OXA)/5-fluorouracil (5-FU) have confirmed their preclinical synergy in advanced colorectal cancer patients.
  • Chemoradiotherapy with 5-FU + leucovorin (LV) is considered the standard treatment in unresectable rectal cancer patients.
  • All drugs were given on 4 days during Weeks 1 and 5 of a standard radiotherapy cycle (50.4 Gy).
  • The following RTOG Grade 3-4 toxicities were reported: diarrhea, 6 patients; cutaneous, 3 patients; neutropenia-leukopenia, 2 patients; and thrombocytopenia, 1 patient; 1 treatment-related death resulted (febrile neutropenia-sepsis after chemoradiotherapy).
  • Only 1 patient had neurosensory Grade 2 (OXA-specific Levi's scale) toxicity.
  • Nine patients had PS worsening during treatment.
  • Median follow-up was 15 months (range: 3.0-43.4 months), median time to progression was 15.7 months (CI 95%, 0, 31.7), and median overall survival was 19.5 months (CI 95%, 18.0, 21).
  • CONCLUSIONS: Outpatient treatment with low-dose, 30-min daily OXA infusion was feasible and very active, with acceptable toxicity.
  • [MeSH-major] Adenocarcinoma / drug therapy. Adenocarcinoma / radiotherapy. Antineoplastic Combined Chemotherapy Protocols / administration & dosage. Rectal Neoplasms / drug therapy. Rectal Neoplasms / radiotherapy
  • [MeSH-minor] Adult. Aged. Combined Modality Therapy. Drug Administration Schedule. Female. Fluorouracil / administration & dosage. Fluorouracil / adverse effects. Follow-Up Studies. Humans. Leucovorin / administration & dosage. Leucovorin / adverse effects. Male. Middle Aged. Neoplasm Staging. Organoplatinum Compounds / administration & dosage. Organoplatinum Compounds / adverse effects. Prognosis

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  • (PMID = 12243813.001).
  • [ISSN] 0360-3016
  • [Journal-full-title] International journal of radiation oncology, biology, physics
  • [ISO-abbreviation] Int. J. Radiat. Oncol. Biol. Phys.
  • [Language] eng
  • [Publication-type] Clinical Trial; Clinical Trial, Phase II; Journal Article; Research Support, Non-U.S. Gov't
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Organoplatinum Compounds; 04ZR38536J / oxaliplatin; Q573I9DVLP / Leucovorin; U3P01618RT / Fluorouracil
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36. Seong J, Cho JH, Kim NK, Min JS, Suh CO: Preoperative chemoradiotherapy with oral doxifluridine plus low-dose oral leucovorin in unresectable primary rectal cancer. Int J Radiat Oncol Biol Phys; 2001 Jun 1;50(2):435-9
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Preoperative chemoradiotherapy with oral doxifluridine plus low-dose oral leucovorin in unresectable primary rectal cancer.
  • Doxifluridine, an oral 5-FU prodrug, has been shown to be effective in colorectal cancer.
  • We attempted a Phase II trial of preoperative chemoradiotherapy with doxifluridine plus a low-dose oral leucovorin in unresectable primary rectal cancer patients.
  • The patients were treated with oral doxifluridine (900 mg/day) plus oral leucovorin (30 mg/day) from days 1 to 35, and pelvic radiation of 45 Gy over 5 weeks.
  • Surgical resection was performed 5-6 weeks after the treatment.
  • All were in Grade 1/2, except diarrhea, which was not only the most frequent (7 patients, 33.3%), but also the only toxicity of Grade 3 (2 patients).
  • CONCLUSION: This study demonstrated the efficacy and low toxicity of chemoradiotherapy with doxifluridine.
  • Currently, a Phase III randomized trial of chemoradiotherapy is ongoing at our institute to compare the therapeutic efficacy of oral 5-FU with respect to i.v.
  • [MeSH-major] Adenocarcinoma / drug therapy. Adenocarcinoma / radiotherapy. Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Rectal Neoplasms / drug therapy. Rectal Neoplasms / radiotherapy
  • [MeSH-minor] Administration, Oral. Adult. Aged. Combined Modality Therapy. Diarrhea / chemically induced. Diarrhea / etiology. Female. Floxuridine / administration & dosage. Floxuridine / adverse effects. Humans. Leucovorin / administration & dosage. Leucovorin / adverse effects. Male. Middle Aged. Preoperative Care. Radiotherapy / adverse effects. Thrombocytopenia / chemically induced. Thrombocytopenia / etiology

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  • (PMID = 11380231.001).
  • [ISSN] 0360-3016
  • [Journal-full-title] International journal of radiation oncology, biology, physics
  • [ISO-abbreviation] Int. J. Radiat. Oncol. Biol. Phys.
  • [Language] eng
  • [Publication-type] Clinical Trial; Clinical Trial, Phase II; Journal Article
  • [Publication-country] United States
  • [Chemical-registry-number] 039LU44I5M / Floxuridine; Q573I9DVLP / Leucovorin; V1JK16Y2JP / doxifluridine
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37. Hochster HS, Hart LL, Ramanathan RK, Childs BH, Hainsworth JD, Cohn AL, Wong L, Fehrenbacher L, Abubakr Y, Saif MW, Schwartzberg L, Hedrick E: Safety and efficacy of oxaliplatin and fluoropyrimidine regimens with or without bevacizumab as first-line treatment of metastatic colorectal cancer: results of the TREE Study. J Clin Oncol; 2008 Jul 20;26(21):3523-9
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Safety and efficacy of oxaliplatin and fluoropyrimidine regimens with or without bevacizumab as first-line treatment of metastatic colorectal cancer: results of the TREE Study.
  • PURPOSE: To evaluate the safety and efficacy of three oxaliplatin and fluoropyrimidine regimens, with or without bevacizumab, as first-line treatment for metastatic colorectal cancer (CRC).
  • PATIENTS AND METHODS: Patients with histologically documented metastatic or recurrent CRC and no prior treatment for advanced disease were randomly assigned to mFOLFOX6 (bolus and infusion fluorouracil [FU] and leucovorin [LV] with oxaliplatin), bFOL (bolus FU and low-dose LV with oxaliplatin), or CapeOx (capecitabine with oxaliplatin), respectively (Three Regimens of Eloxatin Evaluation [TREE-1]).
  • Incidence of grade 3/4 treatment-related adverse events during the first 12 weeks of treatment were 59%, 36%, and 67% for mFOLFOX6, bFOL, and CapeOx, respectively, (TREE-1) and 59%, 51%, and 56% for the corresponding treatments plus bevacizumab (TREE-2; primary end point).
  • CapeOx toxicity in TREE-1 included grade 3/4 diarrhea (31%) and dehydration (27%); capecitabine dose reduction to 1,700 mg/m(2)/d in TREE-2 resulted in improved tolerance.
  • CONCLUSION: The addition of bevacizumab to oxaliplatin and fluoropyrimidine regimens is well tolerated as first-line treatment of mCRC and does not markedly change overall toxicity.
  • First-line oxaliplatin and fluoropyrimidine-based therapy plus bevacizumab resulted in a median OS of approximately 2 years.
  • [MeSH-major] Adenocarcinoma / drug therapy. Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Colorectal Neoplasms / drug therapy

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  • [ErratumIn] J Clin Oncol. 2008 Oct 1;26(28): 4697
  • (PMID = 18640933.001).
  • [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; Multicenter Study; Randomized Controlled Trial
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Antibodies, Monoclonal; 0 / Antibodies, Monoclonal, Humanized; 0 / Organoplatinum Compounds; 04ZR38536J / oxaliplatin; 0W860991D6 / Deoxycytidine; 2S9ZZM9Q9V / Bevacizumab; 6804DJ8Z9U / Capecitabine; Q573I9DVLP / Leucovorin; U3P01618RT / Fluorouracil
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38. Clarke S, Goldstein D, Mitchell P, Michael M, Beale P, Friedlander M, Zalcberg J, White S: Modification of leucovorin dose within a simplified FOLFOX regimen improves tolerability without compromising efficacy. Clin Colorectal Cancer; 2007 Jul;6(8):578-82
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  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • BACKGROUND: This analysis assesses the efficacy and safety of a modified FOLFOX (oxaliplatin/leucovorin [LV]/5-fluorouracil [5-FU]) regimen given with a low dose of LV.
  • PATIENTS AND METHODS: Forty patients with previously untreated metastatic colorectal cancer were enrolled to receive every-2-week cycles of oxaliplatin 100 mg/m(2) intravenously administered over 2 hours concurrently with LV 20 mg/m(2) bolus and 5-FU 400 mg/m(2) bolus, followed by a 46-hour infusion of 5-FU 2.4 g/m(2).
  • RESULTS: Thirty-nine patients received > or = 1 oxaliplatin dose and a median of 10 treatment cycles (range, 1-13 cycles).
  • Thirteen patients (34%) experienced grade 3/4 neutropenia, whereas 21% of patients experienced grade 3 neurotoxicity.
  • [MeSH-major] Adenocarcinoma / drug therapy. Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Colonic Neoplasms / drug therapy. Rectal Neoplasms / drug therapy
  • [MeSH-minor] Adult. Dose-Response Relationship, Drug. Female. Fluorouracil / therapeutic use. Humans. Leucovorin / therapeutic use. Male. Neoplasm Staging. Organoplatinum Compounds / therapeutic use. Survival Rate

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  • (PMID = 17681104.001).
  • [ISSN] 1533-0028
  • [Journal-full-title] Clinical colorectal cancer
  • [ISO-abbreviation] Clin Colorectal Cancer
  • [Language] eng
  • [Publication-type] Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Organoplatinum Compounds; Q573I9DVLP / Leucovorin; U3P01618RT / Fluorouracil; Folfox protocol
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39. Bertolini F, Chiara S, Bengala C, Antognoni P, Dealis C, Zironi S, Malavasi N, Scolaro T, Depenni R, Jovic G, Sonaglio C, Rossi A, Luppi G, Conte PF: Neoadjuvant treatment with single-agent cetuximab followed by 5-FU, cetuximab, and pelvic radiotherapy: a phase II study in locally advanced rectal cancer. Int J Radiat Oncol Biol Phys; 2009 Feb 1;73(2):466-72
Hazardous Substances Data Bank. FLUOROURACIL .

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Neoadjuvant treatment with single-agent cetuximab followed by 5-FU, cetuximab, and pelvic radiotherapy: a phase II study in locally advanced rectal cancer.
  • Cetuximab has proved activity in advanced colorectal cancer, and its incorporation in preoperative treatment may increase tumor downstaging.
  • Sample size was calculated according to Bryant and Day test, a two-stage design with at least 10 pathologic complete remissions observed in 60 patients (pts) able to complete the treatment plan.
  • Thirty-five pts completed neoadjuvant treatment; 5 (12%) withdrew therapy after one cetuximab administration: three for hypersensitivity reactions, one for rapid progression, and one for purulent arthritis.
  • Thirty-one pts (77%) presented with acnelike rash; dose reduction/interruption of treatment was necessary in six pts (15%): two for Grade 3 acnelike rash, two for Grade 3 gastrointestinal toxicity, and two for refusal.
  • Thirty-eight pts were evaluable for pathological response (one patient refused surgery, and one was progressed during neoadjuvant treatment).
  • CONCLUSIONS: Preoperative treatment with 5-FU, cetuximab, and pelvic RT is feasible with acceptable toxicities; however, the rate of pathologic responses is disappointingly low.
  • [MeSH-major] Adenocarcinoma / drug therapy. Adenocarcinoma / radiotherapy. Antineoplastic Combined Chemotherapy Protocols / administration & dosage. Neoadjuvant Therapy / methods. Rectal Neoplasms / drug therapy. Rectal Neoplasms / radiotherapy
  • [MeSH-minor] Adult. Aged. Aged, 80 and over. Antibodies, Monoclonal / administration & dosage. Antibodies, Monoclonal / adverse effects. Antibodies, Monoclonal, Humanized. Cetuximab. Combined Modality Therapy / adverse effects. Combined Modality Therapy / methods. Female. Fluorouracil / administration & dosage. Fluorouracil / adverse effects. Humans. Male. Middle Aged. Neoplasm Staging

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  • (PMID = 19004567.001).
  • [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] Clinical Trial, Phase II; Journal Article; Multicenter Study
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Antibodies, Monoclonal; 0 / Antibodies, Monoclonal, Humanized; PQX0D8J21J / Cetuximab; U3P01618RT / Fluorouracil
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40. Ferreira F, Lopes S, Macedo G: Colon cancer after infliximab therapy for Crohn's disease. BioDrugs; 2010 Dec 14;24 Suppl 1:18-21
Hazardous Substances Data Bank. Infliximab .

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Colon cancer after infliximab therapy for Crohn's disease.
  • Infliximab is an effective agent in the treatment of patients with Crohn's disease.
  • Therapy with infliximab is generally well tolerated but there are concerns about its effects on the incidence of cancer.
  • This case report refers to a 47-year-old patient with long-standing Crohn's disease, without a family history of colorectal cancer, who had a previous diagnosis of low-grade dysplasia that was not confirmed in subsequent studies, and was diagnosed with adenocarcinoma of the colon with peritoneal invasion after the fourth infusion of infliximab.
  • [MeSH-major] Adenocarcinoma / etiology. Anti-Inflammatory Agents / adverse effects. Antibodies, Monoclonal / adverse effects. Colonic Neoplasms / etiology. Crohn Disease / drug therapy

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  • (PMID = 21175230.001).
  • [ISSN] 1179-190X
  • [Journal-full-title] BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy
  • [ISO-abbreviation] BioDrugs
  • [Language] eng
  • [Publication-type] Case Reports; Journal Article; Research Support, Non-U.S. Gov't
  • [Publication-country] New Zealand
  • [Chemical-registry-number] 0 / Anti-Inflammatory Agents; 0 / Antibodies, Monoclonal; B72HH48FLU / Infliximab
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