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1. Fakhr I, El-Hossieny H, Salama A: Delayed Cystectomy for T1G3 Transitional Cell Carcinoma (TCC) of the Urinary Bladder, NCI Retrospective Case Series. J Egypt Natl Canc Inst; 2008 Dec;20(4):387-94

  • [Source] The source of this record is MEDLINE®, a database of the U.S. National Library of Medicine.
  • [Title] Delayed Cystectomy for T1G3 Transitional Cell Carcinoma (TCC) of the Urinary Bladder, NCI Retrospective Case Series.
  • AIM: We aim to evaluate the National Cancer Institute (NCI) treatment protocol and its outcome regarding recurrence, progression and survival in patients with T1G3 urinary bladder transitional cell carcinoma.
  • PATIENTS AND METHODS: In a retrospective study, between January 2001 and December 2007, all 34 patients with T1G3 bladder transitional cell carcinoma (TCC), after complete transurethral resection (TURBT), received intravesical BCG as adjuvant therapy.
  • Two (20.0%) of them, were staged as TNM stage II, 6 (60.0%) as TNM stage III and 2 (20.0%) patients were TNM stage IV.
  • Eight (72.7%) of these 11 patients had post-cystectomy radiotherapy alone; while the 2 (6.0%) other patients with stage IV had adjuvant concomitant Cisplatin and Gemcitabine chemotherapy.
  • CONCLUSION: Adjuvant intravesical therapy with BCG with repeated cystoscopies, and delayed radical cystectomy until progression to the invasive disease carries a significant risk of mortality from invasive disease.
  • This treatment policy may be acceptable for T1G3 bladder TCC, without concomitant carcinoma in situ (CIS), who don't recur after intravesical BCG, however, patients who progress to invasive disease may skip stage II disease and present with stage III or IV, with consequent poor survival.
  • KEY WORDS: Superficial bladder cancer - T1G3 TCC - Delayed cystectomy - BCG.

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  • (PMID = 20571597.001).
  • [ISSN] 1110-0362
  • [Journal-full-title] Journal of the Egyptian National Cancer Institute
  • [ISO-abbreviation] J Egypt Natl Canc Inst
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] Egypt
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2. Herchenhorn D, Dienstmann R, Peixoto FA, de Campos FS, Santos VO, Moreira DM, Cardoso H, Small IA, Ferreira CG: Phase II trial of neoadjuvant gemcitabine and cisplatin in patients with resectable bladder carcinoma. Int Braz J Urol; 2007 Sep-Oct;33(5):630-8; discussion 638
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  • [Title] Phase II trial of neoadjuvant gemcitabine and cisplatin in patients with resectable bladder carcinoma.
  • OBJECTIVES: Gemcitabine and cisplatin (GC) is an active combination in the treatment of metastatic bladder cancer.
  • We have prospectively analyzed the efficacy and tolerability of GC as neoadjuvant treatment of invasive bladder cancer.
  • MATERIALS AND METHODS: In this single-institution phase II trial, patients with muscle-invasive transitional cell carcinoma received three cycles of gemcitabine 1200 mg/m2 on days 1 and 8 with cisplatin 75 mg/m2 on day 1 prior to surgery.
  • Radiologic response was evaluated by computed tomography and magnetic resonance imaging.
  • All patients were referred to surgery after chemotherapy completion.
  • Initial stage was II (T2) in 11 and III (T3-4) in 11 patients.
  • One patient was excluded due to sarcomatoid carcinoma at definitive pathologic examination.
  • Grade III/IV toxicity was infrequent, with no deaths due to chemotherapy.
  • CONCLUSIONS: The combination of GC is effective and well-tolerated when used as neoadjuvant therapy in muscle-invasive bladder cancer.
  • [MeSH-major] Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Carcinoma, Transitional Cell / drug therapy. Urinary Bladder Neoplasms / drug therapy
  • [MeSH-minor] Adolescent. Adult. Aged. Chemotherapy, Adjuvant. Cisplatin / administration & dosage. Deoxycytidine / administration & dosage. Deoxycytidine / analogs & derivatives. Disease-Free Survival. Female. Follow-Up Studies. Humans. Male. Middle Aged. Prospective Studies. Treatment Outcome

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  • [CommentIn] Int Braz J Urol. 2007 Nov-Dec;33(6):840-1 [18199355.001]
  • (PMID = 17980060.001).
  • [ISSN] 1677-5538
  • [Journal-full-title] International braz j urol : official journal of the Brazilian Society of Urology
  • [ISO-abbreviation] Int Braz J Urol
  • [Language] eng
  • [Publication-type] Clinical Trial, Phase II; Journal Article; Research Support, Non-U.S. Gov't
  • [Publication-country] Brazil
  • [Chemical-registry-number] 0W860991D6 / Deoxycytidine; B76N6SBZ8R / gemcitabine; Q20Q21Q62J / Cisplatin
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3. Sylvester RJ, Brausi MA, Kirkels WJ, Hoeltl W, Calais Da Silva F, Powell PH, Prescott S, Kirkali Z, van de Beek C, Gorlia T, de Reijke TM, EORTC Genito-Urinary Tract Cancer Group: Long-term efficacy results of EORTC genito-urinary group randomized phase 3 study 30911 comparing intravesical instillations of epirubicin, bacillus Calmette-Guérin, and bacillus Calmette-Guérin plus isoniazid in patients with intermediate- and high-risk stage Ta T1 urothelial carcinoma of the bladder. Eur Urol; 2010 May;57(5):766-73
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  • [Title] Long-term efficacy results of EORTC genito-urinary group randomized phase 3 study 30911 comparing intravesical instillations of epirubicin, bacillus Calmette-Guérin, and bacillus Calmette-Guérin plus isoniazid in patients with intermediate- and high-risk stage Ta T1 urothelial carcinoma of the bladder.
  • BACKGROUND: Intravesical chemotherapy and bacillus Calmette-Guérin (BCG) reduce the recurrence rate in patients with stage Ta T1 urothelial bladder cancer; however, the benefit of BCG relative to chemotherapy for long-term end points is controversial, especially in intermediate-risk patients.
  • DESIGN, SETTING, AND PARTICIPANTS: From January 1992 to February 1997, 957 patients with intermediate- or high-risk stage Ta T1 urothelial bladder cancer were randomized after transurethral resection to one of three treatment groups in the European Organization for Research and Treatment of Cancer Genito-Urinary Group phase 3 trial 30911.
  • MEASUREMENTS: End points were time to recurrence, progression, distant metastases, overall survival, and disease-specific survival.
  • RESULTS AND LIMITATIONS: With 837 eligible patients and a median follow-up of 9.2 yr, time to first recurrence (p<0.001), distant metastases (p=0.046), overall survival (p=0.023), and disease-specific survival (p=0.026) were significantly longer in the two BCG arms combined as compared with epirubicin; however, there was no difference for progression.
  • Three hundred twenty-three patients with stage T1 or grade 3 tumors were high risk, and the remaining 497 patients were intermediate risk.
  • The observed treatment benefit was at least as large, if not larger, in the intermediate-risk patients compared with the high-risk patients.
  • CONCLUSIONS: In patients with intermediate- and high-risk stage Ta and T1 urothelial bladder cancer, intravesical BCG with or without INH is superior to intravesical epirubicin not only for time to first recurrence but also for time to distant metastases, overall survival, and disease-specific survival.

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  • [Copyright] Copyright © 2009 European Association of Urology. Published by Elsevier B.V. All rights reserved.
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  • (PMID = 20034729.001).
  • [ISSN] 1873-7560
  • [Journal-full-title] European urology
  • [ISO-abbreviation] Eur. Urol.
  • [Language] ENG
  • [Grant] United States / NCI NIH HHS / CA / U10 CA011488; United States / NCI NIH HHS / CA / U10 CA011488-39; United States / NCI NIH HHS / CA / CA011488-38; United States / NCI NIH HHS / CA / CA011488-37; United States / NCI NIH HHS / CA / CA011488-39; United States / NCI NIH HHS / CA / U10 CA011488-38; United States / NCI NIH HHS / CA / 5U10 CA011488-37; United States / NCI NIH HHS / CA / 5U10 CA011488-39; United States / NCI NIH HHS / CA / U10 CA011488-37
  • [Publication-type] Clinical Trial, Phase III; Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't
  • [Publication-country] Switzerland
  • [Chemical-registry-number] 0 / Adjuvants, Immunologic; 0 / Antibiotics, Antineoplastic; 0 / BCG Vaccine; 3Z8479ZZ5X / Epirubicin; V83O1VOZ8L / Isoniazid
  • [Other-IDs] NLM/ NIHMS167431; NLM/ PMC2889174
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4. Ardavanis A, Tryfonopoulos D, Alexopoulos A, Kandylis C, Lainakis G, Rigatos G: Gemcitabine and docetaxel as first-line treatment for advanced urothelial carcinoma: a phase II study. Br J Cancer; 2005 Feb 28;92(4):645-50
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  • [Title] Gemcitabine and docetaxel as first-line treatment for advanced urothelial carcinoma: a phase II study.
  • The purpose of the study was to investigate the toxicity and efficacy of the combination of gemcitabine and docetaxel in untreated advanced urothelial carcinoma.
  • Patients with previously untreated, locally advanced/recurrent or metastatic urothelial carcinoma stage-IV disease were eligible.
  • Study treatment consisted of docetaxel 75 mg m(-2) (day 8) and gemcitabine 1000 mg m(-2) (days 1+8), every 21 days for a total of six to nine cycles.
  • A total of 31 patients with urothelial bladder cancer, 25 men and six women, aged 42-74 (median 64) years were enrolled.
  • The median time to progression was 8 months (95% CI 5.1-9.2 months) and the median overall survival was 15 months (95% CI 11.2-18.5 months), with 1-year survival rate of 60%.
  • In conclusion, this schedule of gemcitabine and docetaxel is very active and well tolerated as a first-line treatment for advanced/relapsing or metastatic urothelial carcinoma.
  • Although its relative efficacy and tolerance as compared to classic MVAC should be assessed in a phase III setting, the favourable toxicity profile of this regimen may offer an interesting alternative, particularly in patients with compromised renal function or cardiovascular disease.
  • [MeSH-major] Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Carcinoma, Transitional Cell / drug therapy. Deoxycytidine / analogs & derivatives. Urologic Neoplasms / drug therapy
  • [MeSH-minor] Adult. Aged. Antimetabolites, Antineoplastic / administration & dosage. Antineoplastic Agents, Phytogenic / administration & dosage. Drug Administration Schedule. Female. Humans. Male. Middle Aged. Neoplasm Staging. Survival Analysis. Taxoids / administration & dosage. Treatment Outcome. Urothelium / pathology

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  • (PMID = 15685232.001).
  • [ISSN] 0007-0920
  • [Journal-full-title] British journal of cancer
  • [ISO-abbreviation] Br. J. Cancer
  • [Language] eng
  • [Publication-type] Clinical Trial; Clinical Trial, Phase II; Journal Article
  • [Publication-country] England
  • [Chemical-registry-number] 0 / Antimetabolites, Antineoplastic; 0 / Antineoplastic Agents, Phytogenic; 0 / Taxoids; 0W860991D6 / Deoxycytidine; 15H5577CQD / docetaxel; B76N6SBZ8R / gemcitabine
  • [Other-IDs] NLM/ PMC2361881
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5. Kommoss F, Kommoss S, Schmidt D, Trunk MJ, Pfisterer J, du Bois A, Arbeitsgemeinschaft Gynaekologische Onkologie Studiengruppe Ovarialkarzinom: Survival benefit for patients with advanced-stage transitional cell carcinomas vs. other subtypes of ovarian carcinoma after chemotherapy with platinum and paclitaxel. Gynecol Oncol; 2005 Apr;97(1):195-9
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  • [Title] Survival benefit for patients with advanced-stage transitional cell carcinomas vs. other subtypes of ovarian carcinoma after chemotherapy with platinum and paclitaxel.
  • OBJECTIVE: Transitional cell carcinoma (TCC) of the ovary is a less well recognized histological type of ovarian carcinoma resembling TCC of the urinary bladder.
  • It was the aim of the present retrospective study to compare incidence and outcome of patients with TCCs and other subtypes of ovarian carcinoma from a large homogeneous collective of patients with primary advanced-stage ovarian carcinoma.
  • METHODS: H and E-stained sections from a total of 302 cases from a prospective randomized, multi-center, phase III study of patients with ovarian cancer, FIGO-stages IIB-IV, comparing cisplatin plus paclitaxel (PT) with paclitaxel plus carboplatin (TC) were available for histological retyping of ovarian carcinomas applying current WHO criteria.
  • 5-year survival of patients with TCC was 57% as compared to 31% for patients with ovarian carcinomas of other types (P = 0.03).
  • In the current series, TCCs had a significantly better prognosis as compared to all other types of ovarian carcinomas after standardized chemotherapy.
  • [MeSH-major] Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Carcinoma, Transitional Cell / drug therapy. Ovarian Neoplasms / drug therapy

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  • (PMID = 15790458.001).
  • [ISSN] 0090-8258
  • [Journal-full-title] Gynecologic oncology
  • [ISO-abbreviation] Gynecol. Oncol.
  • [Language] eng
  • [Publication-type] Clinical Trial; Clinical Trial, Phase III; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial
  • [Publication-country] United States
  • [Chemical-registry-number] BG3F62OND5 / Carboplatin; P88XT4IS4D / Paclitaxel; Q20Q21Q62J / Cisplatin
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6. Goffin JR, Rajan R, Souhami L: Tolerance of radiotherapy and chemotherapy in elderly patients with bladder cancer. Am J Clin Oncol; 2004 Apr;27(2):172-7
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  • [Title] Tolerance of radiotherapy and chemotherapy in elderly patients with bladder cancer.
  • Bladder-sparing radiotherapy with concurrent chemotherapy may be a reasonable alternative to cystectomy in patients with invasive bladder cancer.
  • The purpose of this study was to determine the tolerance of combined treatment in elderly patients.
  • In this retrospective study, the records of patients 70 or more years of age with stage T2-T4a, N0, M0 disease who were treated with bladder-sparing regimens between 1985 and 2000 were examined for toxicity.
  • Of 149 consecutive patients treated for cancer of the bladder, 14 patients met eligibility criteria.
  • All patients had at least mild toxicity, with 6 of 14 patients having grade III to IV toxicity.
  • Grade III to IV toxicities included one patient with grade IV neutropenia, three with grade III gastrointestinal toxicities, one patient with grade III urinary frequency, one patient with grade IV ureteral obstruction who required stent placement, and one episode of hydration-induced grade III heart failure.
  • Two of 14 patients stopped chemotherapy and 5 patients required dose reductions for toxicity.
  • The observed rates of toxicity compare favorably with studies of bladder-sparing therapy in patients with median ages less than 70 years.
  • Our study shows that bladder-sparing radiotherapy with concurrent chemotherapy is feasible in patients 70 or more years of age, and should be considered for such patients if they are inoperable or strongly wish to avoid cystectomy.
  • [MeSH-major] Urinary Bladder Neoplasms / drug therapy. Urinary Bladder Neoplasms / radiotherapy
  • [MeSH-minor] Aged. Aged, 80 and over. Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Carcinoma, Squamous Cell / drug therapy. Carcinoma, Squamous Cell / radiotherapy. Carcinoma, Transitional Cell / drug therapy. Carcinoma, Transitional Cell / radiotherapy. Cisplatin / administration & dosage. Combined Modality Therapy. Dose Fractionation. Female. Fluorouracil / administration & dosage. Humans. Male. Methotrexate / administration & dosage. Retrospective Studies. Survival Analysis. Treatment Outcome. Vinblastine / administration & dosage

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  • (PMID = 15057157.001).
  • [ISSN] 1537-453X
  • [Journal-full-title] American journal of clinical oncology
  • [ISO-abbreviation] Am. J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article; Research Support, Non-U.S. Gov't
  • [Publication-country] United States
  • [Chemical-registry-number] 5V9KLZ54CY / Vinblastine; Q20Q21Q62J / Cisplatin; U3P01618RT / Fluorouracil; YL5FZ2Y5U1 / Methotrexate
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7. Altay B, Girgin C, Kefi A, Cikili N: The best management of superficial bladder tumours: comparing TUR alone versus TUR combined with intravesical chemotherapy modalities? Int Urol Nephrol; 2000;32(1):53-8
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  • [Title] The best management of superficial bladder tumours: comparing TUR alone versus TUR combined with intravesical chemotherapy modalities?
  • To compare retrospectively the recurrence rates of TUR alone versus different intravesical chemotherapy modalities in superficial bladder cancer cases, 187 patients with stage Ta and T1 bladder tumours were treated with transurethral resection followed by adjuvant intravesical chemotherapy with mitomycin, BCG or epirubicin or by transurethral resection alone.
  • All patients in this study had historically proven transurethrally resectable primary, category Ta and T1 transitional cell carcinoma (TCC) of the bladder.
  • Group I included transurethral resection alone, and the other groups included intravesical mitomycin-C (Group II), BCG (Group III) and epirubicin (Group IV) therapies after transurethral resection.
  • 146 male and 41 female patients (78% male and 22% female patients) in this study were diagnosed as primary TCC bladder tumours.
  • Only 52 of them were stage Ta and 135 of them were stage T1 bladder tumours.
  • Examining the histological grade of the bladder tumours, 88 (47%) of the patients had grade I, 53 (28%) had grade IIa, 30 (16%) had grade IIb and remaining 16 (9%) had grade III bladder cancers.
  • The recurrence rates were 25% for Group I, 23.8% for Group II, 26.2% for Group III and 22.7% for Group IV.
  • These values were given with disregarding the grade and volume of the bladder tumours.
  • For solitary, less than 3 cm low grade tumours (grade I, IIa) recurrence rates were 16% for Group I, 15.4% for Group II, 17.8% for Group III, 17.2% for Group IV (p > 0.05).
  • As a result of this retrospective study, for patients with low grade, stage Ta and T1 tumours TUR alone may be the best treatment modality.
  • Although intravesical chemotherapy is effective in decreasing short-term incidences of tumour recurrence, it has not decreased long-term incidences of tumour recurrence.
  • The high cost and adverse side effects of intravesical chemotherapy should also be taken into consideration in superficial, single, low grade tumours of bladder.
  • [MeSH-major] Carcinoma, Transitional Cell / drug therapy. Carcinoma, Transitional Cell / surgery. Urinary Bladder Neoplasms / drug therapy. Urinary Bladder Neoplasms / surgery
  • [MeSH-minor] Administration, Intravesical. Adult. Aged. Combined Modality Therapy. Female. Humans. Male. Middle Aged. Neoplasm Recurrence, Local / epidemiology. Neoplasm Staging. Retrospective Studies

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  • (PMID = 11057773.001).
  • [ISSN] 0301-1623
  • [Journal-full-title] International urology and nephrology
  • [ISO-abbreviation] Int Urol Nephrol
  • [Language] eng
  • [Publication-type] Comparative Study; Journal Article
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8. David KA, Milowsky MI, Ritchey J, Carroll PR, Nanus DM: Low incidence of perioperative chemotherapy for stage III bladder cancer 1998 to 2003: a report from the National Cancer Data Base. J Urol; 2007 Aug;178(2):451-4
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  • [Title] Low incidence of perioperative chemotherapy for stage III bladder cancer 1998 to 2003: a report from the National Cancer Data Base.
  • PURPOSE: Studies of perioperative chemotherapy for muscle invasive bladder cancer have shown a survival benefit with combined modality therapy.
  • We reviewed chemotherapy use in patients with stage III transitional cell carcinoma of the bladder from 1998 to 2003 to evaluate perioperative chemotherapy treatment patterns.
  • MATERIALS AND METHODS: The National Cancer Data Base collected data on approximately 60% of all newly diagnosed bladder cancer cases in the United States from 1998 to 2003.
  • We queried the National Cancer Data Base for all treatment of male and female patients 18 years old or older with bladder transitional cell carcinoma diagnosed between 1998 and 2003.
  • A total of 224,060 bladder transitional cell carcinoma records were reviewed.
  • Perioperative chemotherapy was defined as chemotherapy given within 4 months before and 4 months after surgery.
  • Of 11,339 cases of stage III bladder cancer treatment, analysis was possible for 7,161.
  • RESULTS: Treatment patterns were analyzed in 7,161 patients with stage III bladder transitional cell carcinoma.
  • Perioperative chemotherapy was administered to 11.6% of patients with stage III bladder transitional cell carcinoma with 10.4% receiving adjuvant chemotherapy and 1.2% receiving neoadjuvant chemotherapy.
  • When comparing perioperative chemotherapy use by diagnosis year in 1998 and 2003, a small statistically significant increase was observed using the Pearson's chi-square test with Bonferroni correction (p <0.05) at 11.3% of patients in 1998 vs 16.8% in 2003.
  • CONCLUSIONS: Perioperative chemotherapy is underused in the management of surgically resectable stage III transitional cell carcinoma of the bladder.
  • This finding may reflect a delay in implementing the results of recently reported randomized trials, a low incidence of referrals by urologists for chemotherapy and/or confidence in salvage chemotherapy as an equivalent alternative.
  • Further followup will determine if this treatment pattern changes in the future.
  • [MeSH-major] Antineoplastic Agents / therapeutic use. Carcinoma, Transitional Cell / drug therapy. Chemotherapy, Adjuvant / utilization. Neoadjuvant Therapy / utilization. Urinary Bladder Neoplasms / drug therapy
  • [MeSH-minor] Adolescent. Adult. Aged. Aged, 80 and over. Combined Modality Therapy / utilization. Cystectomy. Databases, Factual. Female. Humans. Male. Middle Aged. Neoplasm Invasiveness. Neoplasm Staging. Retrospective Studies. United States. Urinary Bladder / pathology. Utilization Review

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  • (PMID = 17561135.001).
  • [ISSN] 0022-5347
  • [Journal-full-title] The Journal of urology
  • [ISO-abbreviation] J. Urol.
  • [Language] eng
  • [Publication-type] Journal Article; Research Support, Non-U.S. Gov't
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Antineoplastic Agents
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9. Andreadis C, Touloupidis S, Galaktidou G, Kortsaris AH, Boutis A, Mouratidou D: Serum CYFRA 21-1 in patients with invasive bladder cancer and its relevance as a tumor marker during chemotherapy. J Urol; 2005 Nov;174(5):1771-5; discussion 1775-6
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  • [Title] Serum CYFRA 21-1 in patients with invasive bladder cancer and its relevance as a tumor marker during chemotherapy.
  • PURPOSE: Previous studies have shown that serum levels of the degradation products of cytokeratins could be used as surrogate markers in the diagnosis and followup of patients with solid tumors, including tumors of the bladder.
  • MATERIALS AND METHODS: The soluble cytokeratin 19 fragment CYFRA 21-1 was measured by solid phase radioimmunoassay in the serum of 142 patients with invasive transitional cell cancer of the bladder.
  • Of the patients 56 had clinical stage I to III locally confined disease (T1-4aN0M0) and 86 had stage IV metastatic disease with lymph node and/or distant metastases.
  • In a subgroup of 49 patients with metastatic disease receiving combined platinum based chemotherapy serum CYFRA 21-1 was determined prior to the initiation of therapy and after the documentation of response.
  • Moreover, in the subgroup of patients with metastatic disease receiving chemotherapy CYFRA 21-1 levels correlated with the response to treatment.
  • CONCLUSIONS: Patients with transitional cell cancer of the bladder with evidence of distant metastases showed a significant increase in serum CYFRA 21-1.
  • During chemotherapy CYFRA 21-1 appears to be a potentially sensitive and useful indicator for monitoring treatment response.
  • [MeSH-major] Antigens, Neoplasm / blood. Biomarkers, Tumor / blood. Carcinoma, Transitional Cell / drug therapy. Neoplasm Invasiveness / pathology. Urinary Bladder Neoplasms / drug therapy
  • [MeSH-minor] Aged. Analysis of Variance. Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Case-Control Studies. Cohort Studies. Female. Humans. Keratin-19. Keratins. Male. Middle Aged. Monitoring, Physiologic / methods. Neoplasm Staging. Prognosis. Reference Values. Risk Assessment. Sensitivity and Specificity. Statistics, Nonparametric. Survival Analysis. Treatment Outcome

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  • (PMID = 16217281.001).
  • [ISSN] 0022-5347
  • [Journal-full-title] The Journal of urology
  • [ISO-abbreviation] J. Urol.
  • [Language] eng
  • [Publication-type] Comparative Study; Journal Article
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Antigens, Neoplasm; 0 / Biomarkers, Tumor; 0 / Keratin-19; 0 / antigen CYFRA21.1; 68238-35-7 / Keratins
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10. García González J, Pérez Fentes D, Aliste Santos C, Suárez Peñaranda JM, León Mateos L, López López R: [Use of M-VAC in the adjuvant treatment of sarcomatoid carcinoma of the bladder]. Actas Urol Esp; 2009 Apr;33(4):447-9
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  • [Title] [Use of M-VAC in the adjuvant treatment of sarcomatoid carcinoma of the bladder].
  • [Transliterated title] Empleo de M-VAC en el tratamiento adyuvante del carcinoma sarcomatoide de vejiga.
  • Sarcomatoid bladder carcinoma is a high-grade neoplasm and accounts for approximately 0,3% of all bladder malignancies.
  • Sarcomatoid carcinoma originates from transitional cells of the bladder.
  • Sarcomatoid carcinoma is charactericed by a epithelial component and a sarcomatoid component, consisting of spindle cells, that is only epithelial marker-positive.
  • We report a 26-year-old woman diagnosed of stage III sarcomatoid bladder carcinoma (T3aN0M0) treated with partial cistectomy followed by 4 cycles of adjuvant chemotherapy with methotrexate, vinblastine, doxorubicin and cisplatin.
  • [MeSH-major] Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Carcinoma, Transitional Cell / drug therapy. Urinary Bladder Neoplasms / drug therapy
  • [MeSH-minor] Adult. Chemotherapy, Adjuvant. Cisplatin / therapeutic use. Doxorubicin / therapeutic use. Female. Humans. Methotrexate / therapeutic use. Vinblastine / therapeutic use

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  • (PMID = 19579900.001).
  • [ISSN] 0210-4806
  • [Journal-full-title] Actas urologicas espanolas
  • [ISO-abbreviation] Actas Urol Esp
  • [Language] spa
  • [Publication-type] Case Reports; English Abstract; Journal Article
  • [Publication-country] Spain
  • [Chemical-registry-number] 5V9KLZ54CY / Vinblastine; 80168379AG / Doxorubicin; Q20Q21Q62J / Cisplatin; YL5FZ2Y5U1 / Methotrexate; M-VAC protocol
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11. Ro JY, Shen SS, Lee HI, Hong EK, Lee YH, Cho NH, Jung SJ, Choi YJ, Ayala AG: Plasmacytoid transitional cell carcinoma of urinary bladder: a clinicopathologic study of 9 cases. Am J Surg Pathol; 2008 May;32(5):752-7
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  • [Title] Plasmacytoid transitional cell carcinoma of urinary bladder: a clinicopathologic study of 9 cases.
  • In this report, we summarized the clinicopathologic features of 9 cases of plasmacytoid transitional cell carcinoma (TCC) of the urinary bladder, a rare variant of TCC.
  • All 9 patients were men with a mean of age 64.3 years (range, 46 to 81 y).
  • One patient had TNM stage I disease, 2 had stage II disease, 3 had stage III disease, and 3 had stage IV disease.
  • Four patients were treated by radical cystectomy with chemotherapy, 2 by radical cystectomy alone, 1 each by chemotherapy or intravesical bacillus Calmette-Guerin infusion alone, and 1 did not receive any further therapy.
  • Eight of 9 cases were associated with high-grade TCC, and transitional cell carcinoma in situ was present in 4 cases.
  • Interestingly, plasmacytoid transitional cell carcinoma in situ was noted in 1 case.
  • The mean follow-up in 8 patients was 24.5 months (range, 5 to 47 mo); the other patient was lost to follow-up.
  • In summary, plasmacytoid TCC tends to present at an advanced stage and to have a poor prognosis.
  • [MeSH-major] Carcinoma, Transitional Cell / pathology. Plasma Cells / pathology. Urinary Bladder Neoplasms / pathology
  • [MeSH-minor] Aged. Aged, 80 and over. Biomarkers, Tumor / analysis. Carcinoma in Situ / pathology. Cell Nucleus / pathology. Combined Modality Therapy. Cystoscopy. Cytoplasm / pathology. Humans. Immunohistochemistry. Male. Middle Aged. Neoplasm Staging. Prognosis. Treatment Outcome

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  • (PMID = 18379419.001).
  • [ISSN] 1532-0979
  • [Journal-full-title] The American journal of surgical pathology
  • [ISO-abbreviation] Am. J. Surg. Pathol.
  • [Language] eng
  • [Publication-type] Case Reports; Journal Article
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Biomarkers, Tumor
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12. Khaled HM, Hamza MR, Mansour O, Gaafar R, Zaghloul MS: A phase II study of gemcitabine plus cisplatin chemotherapy in advanced bilharzial bladder carcinoma. Eur J Cancer; 2000 Jul;36 Suppl 2:34-7
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  • [Title] A phase II study of gemcitabine plus cisplatin chemotherapy in advanced bilharzial bladder carcinoma.
  • Bilharzial bladder cancer represents a distinct clinicopathological entity.
  • To investigate whether gemcitabine-cisplatin is also active against bladder cancer of bilharzial origin, we performed a phase II study of previously untreated patients with stage III/IV disease.
  • Thus, these data suggest that gemcitabine plus cisplatin induces high response rates in patients with bilharzial bladder cancer with a moderate toxicity profile.
  • [MeSH-major] Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Carcinoma, Transitional Cell / drug therapy. Schistosomiasis / drug therapy. Urinary Bladder Neoplasms / drug therapy
  • [MeSH-minor] Adult. Aged. Aged, 80 and over. Cisplatin / administration & dosage. Deoxycytidine / administration & dosage. Deoxycytidine / analogs & derivatives. Female. Humans. Male. Middle Aged. Treatment Outcome

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  • (PMID = 10908847.001).
  • [ISSN] 0959-8049
  • [Journal-full-title] European journal of cancer (Oxford, England : 1990)
  • [ISO-abbreviation] Eur. J. Cancer
  • [Language] eng
  • [Publication-type] Clinical Trial; Clinical Trial, Phase II; Journal Article
  • [Publication-country] ENGLAND
  • [Chemical-registry-number] 0W860991D6 / Deoxycytidine; B76N6SBZ8R / gemcitabine; Q20Q21Q62J / Cisplatin
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13. Harshman LC, Bepler G, Zheng Z, Higgins JP, Allen GI, Tibshirani R, Srinivas S: Correlation of RRM1 expression in muscle invasive locally advanced urothelial cancer with age. J Clin Oncol; 2009 May 20;27(15_suppl):e16021

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  • [Title] Correlation of RRM1 expression in muscle invasive locally advanced urothelial cancer with age.
  • : e16021 Background: RRM1, the regulatory subunit of ribonucleotide reductase, plays a role in DNA repair after chemotherapy damage and in gemcitabine metabolism.
  • Prior studies demonstrated a survival benefit to high expression in resected early stage lung cancer and a trend toward longer time to progression with low expression in advanced bladder cancers treated with gemcitabine and cisplatin.
  • We hypothesized that patients with resected locally advanced (T2-4NxM0) urothelial transitional cell carcinoma (TCC) whose tumors had higher RRM1 expression would have longer overall survival (OS).
  • METHODS: 84 radical cystectomy specimens with muscle invasive TCC were identified from existing tissue microarrays (TMAs) containing 343 specimens.
  • The medical records of these patients were retrospectively reviewed to confirm pathology and stage.
  • There was near equal distribution of stages: 30%, 38%, and 32% for stage II, III, and IV respectively.

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  • (PMID = 27962985.001).
  • [ISSN] 1527-7755
  • [Journal-full-title] Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • [ISO-abbreviation] J. Clin. Oncol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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14. Khaled H, Emara ME, Gaafar RM, Mansour O, Abdel Warith A, Zaghloul MS, El Malt O: Primary chemotherapy with low-dose prolonged infusion gemcitabine and cisplatin in patients with bladder cancer: a Phase II trial. Urol Oncol; 2008 Mar-Apr;26(2):133-6
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  • [Title] Primary chemotherapy with low-dose prolonged infusion gemcitabine and cisplatin in patients with bladder cancer: a Phase II trial.
  • BACKGROUND: Gemcitabine is an active agent in the treatment of bladder cancer.
  • After an infusion during 30 minutes, this enzyme will be saturated, therefore, accumulation of higher intracellular concentrations of the active gemcitabine triphosphate could be achieved by prolonging the infusion time of gemcitabine.
  • PATIENTS AND METHODS: Based on previously published Phase I trials, the efficacy and safety of a combination of cisplatin and gemcitabine given as prolonged infusion were tried in a Phase II study of 57 untreated patients with stage III/IV bladder cancer, which is the most common malignant tumor among Egyptian males.
  • A total of 37 patients had transitional cell, 15 had squamous cell, 2 had adenocarcinoma, and 3 had undifferentiated cell carcinoma.
  • CONCLUSIONS: Prolonged infusion of gemcitabine and cisplatin is an effective treatment for advanced bilharzial-related bladder cancer.
  • [MeSH-major] Antineoplastic Agents / administration & dosage. Antineoplastic Combined Chemotherapy Protocols / administration & dosage. Cisplatin / administration & dosage. Deoxycytidine / analogs & derivatives. Urinary Bladder Neoplasms / drug therapy

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  • (PMID = 18312930.001).
  • [ISSN] 1078-1439
  • [Journal-full-title] Urologic oncology
  • [ISO-abbreviation] Urol. Oncol.
  • [Language] eng
  • [Publication-type] Clinical Trial, Phase II; Journal Article
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Antineoplastic Agents; 0W860991D6 / Deoxycytidine; B76N6SBZ8R / gemcitabine; Q20Q21Q62J / Cisplatin
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15. Lebret T, Bohin D, Kassardjian Z, Herve JM, Molinie V, Barre P, Lugagne PM, Botto H: Recurrence, progression and success in stage Ta grade 3 bladder tumors treated with low dose bacillus Calmette-Guerin instillations. J Urol; 2000 Jan;163(1):63-7
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  • [Title] Recurrence, progression and success in stage Ta grade 3 bladder tumors treated with low dose bacillus Calmette-Guerin instillations.
  • PURPOSE: Bacillus Calmette-Guerin (BCG) therapy is considered to be an effective prophylactic and therapeutic agent for high risk superficial transitional cell carcinoma of the bladder.
  • Nevertheless, in a select uncommon population of stage Ta grade 3 superficial lamina-free tumors the results of this treatment have not yet been well established.
  • We evaluated recurrence and progression rates, and the success of BCG therapy in a population with stage Ta grade 3 transitional cell carcinoma of the bladder.
  • MATERIALS AND METHODS: Of the 605 patients treated at our institution from 1982 to 1996 for the histopathological diagnosis of primary bladder cancer 32 (5.3%) with stage Ta grade 3 noninvasive primary bladder tumor were treated with intravesical instillations of 75 mg.
  • At a followup of 2 to 13 years (mean 58.4 months) patients were evaluated with urinary cytology, cystoscopy, transurethral resection and random mucosal biopsies.
  • Recurrence, grade and stage progression, death and causality were analyzed.
  • RESULTS: Of the 32 patients 9 (28%) responded positively to BCG without recurrence, while disease recurred as stage Ta in 8 (25%) and T1 in 7 (22%), and progressed to muscle layer infiltration in 8 (25%).
  • Four patients (12%) died of bladder cancer.
  • The number of tumors at primary resection, gross examination, the mitotic index or an association with carcinoma in situ did not appear to be predictive factors of progression to muscle invasion.
  • Urine cytology (I to II versus III to IV) appeared to correlate highly with progression and BCG response (p<0.001) with excellent sensitivity (1) but low specificity (0.67).
  • CONCLUSIONS: Our study demonstrates the high progression potential of stage Ta grade 3 tumors, since nearly 50% recurred and 25% progressed to invasive disease.
  • These results may be closely compared with the results of previous trials of stage T1 grade 3 disease.
  • We suggest that recurrence should be detected at an early stage using long-term followup with strict observance of the surveillance protocols during a minimum 5-year tumor-free period.
  • [MeSH-major] Adjuvants, Immunologic / administration & dosage. BCG Vaccine / administration & dosage. Carcinoma, Transitional Cell / drug therapy. Carcinoma, Transitional Cell / pathology. Neoplasm Recurrence, Local / epidemiology. Urinary Bladder Neoplasms / drug therapy. Urinary Bladder Neoplasms / pathology

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  • [CommentIn] J Urol. 2000 Jan;163(1):79-80 [10604318.001]
  • (PMID = 10604315.001).
  • [ISSN] 0022-5347
  • [Journal-full-title] The Journal of urology
  • [ISO-abbreviation] J. Urol.
  • [Language] eng
  • [Publication-type] Clinical Trial; Journal Article
  • [Publication-country] UNITED STATES
  • [Chemical-registry-number] 0 / Adjuvants, Immunologic; 0 / BCG Vaccine
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16. Mack D, Höltl W, Bassi P, Brausi M, Ferrari P, de Balincourt C, Sylvester R, European Organization for Research and Treatment of Cancer Genitourinary Group: The ablative effect of quarter dose bacillus Calmette-Guerin on a papillary marker lesion of the bladder. J Urol; 2001 Feb;165(2):401-3
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  • [Title] The ablative effect of quarter dose bacillus Calmette-Guerin on a papillary marker lesion of the bladder.
  • PURPOSE: Low dose bacillus Calmette-Guerin (BCG) for stage TaT1 transitional cell carcinoma of the bladder has been given in various studies with the aim of decreasing side effects while maintaining the same efficacy as full dose bacillus Calmette-Guerin.
  • We examined the ablative activity and incidence of side effects of intravesical quarter dose BCG given for a papillary marker lesion of the bladder.
  • MATERIALS AND METHODS: Included in our study were 44 patients with primary or recurrent, multiple but no more than 10 lesions of stage pTaT1, grades 1 to 2 transitional cell carcinoma of the bladder.
  • Intravesical treatment begun 14 days after the complete transurethral resection of all visible tumors except 1 marker lesion no larger than 1 cm. consisted of instillations of 30 mg.
  • RESULTS: There was a complete response in 27 of the 44 patients (61%), no response in 12 (27%) and progression to carcinoma in situ in 1 (2%), while the response was not evaluable in 4.
  • CONCLUSIONS: Quarter dose BCG has a clear ablative effect on superficial bladder cancer with a 61% response rate.
  • Phase III trials are now required to compare its efficacy and toxicity to those of full dose BCG.
  • [MeSH-major] Adjuvants, Immunologic / administration & dosage. BCG Vaccine / administration & dosage. Carcinoma, Transitional Cell / drug therapy. Urinary Bladder Neoplasms / drug therapy
  • [MeSH-minor] Adult. Aged. Aged, 80 and over. Female. Humans. Male. Middle Aged. Neoplasm Recurrence, Local / drug therapy. Neoplasm Staging. Postoperative Care

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  • (PMID = 11176382.001).
  • [ISSN] 0022-5347
  • [Journal-full-title] The Journal of urology
  • [ISO-abbreviation] J. Urol.
  • [Language] eng
  • [Grant] United States / NCI NIH HHS / CA / 2U10 CA11488-25; United States / NCI NIH HHS / CA / 2U10 CA11488-28; United States / NCI NIH HHS / CA / 5U10 CA11488-26; United States / NCI NIH HHS / CA / 5U10 CA11488-27
  • [Publication-type] Clinical Trial; Journal Article; Research Support, U.S. Gov't, P.H.S.
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Adjuvants, Immunologic; 0 / BCG Vaccine
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17. Startsev VY: The role of combined method in organ-sparing treatment of muscle-invasive bladder cancer recurrences. Arch Ital Urol Androl; 2002 Jun;74(2):54-6
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  • [Title] The role of combined method in organ-sparing treatment of muscle-invasive bladder cancer recurrences.
  • OBJECTIVE: To determine the local control and survival of patients with bladder cancer recurrences (BCR) treated by operative methods, external beam radiotherapy (EBRT) and adjuvant chemotherapy (ACT).
  • MATERIALS AND METHODS: We have treated 180 patients (114 men, median age 64.5 years, range 56-73) with documented transitional-cell non-metastasized BC recurrences: 90 T2N0M0 and 90 T3aN0M0.
  • All patients received different operations (transurethral resection and partial cystectomies) and definitive EBRT (total dose varied from 50 to 64 Gy with a mean of 60.5 Gy, 5 days a week).
  • In a second group of patients we performed 3 courses of 4-drug regimen ACT administered with EBRT.
  • ACT consisting of cisplatin and adriamycin i.a. and methotrexate and vinblastin i.v. (M-VAC) was administered on the fourth week after radiation therapy.
  • The complete response rates in patients with clinical stage T2 and T3a disease was 64.4 and 44.4%, respectively and it was slightly higher in patients with a non-papillary cancer than in those with a papillary one.
  • The acute toxicity was mild: no hematological and renal toxicity over grade II, 14 (7.8%) cases of bowel or rectal reversible grade II toxicity and 12 (6.7%) cases of reversible grade III cystitis.
  • CONCLUSIONS: Four-drug ACT is feasible without major toxicity and offers a potentially curative and conservative treatment for patients with localized muscle-invasive BC (bladder cancer) recurrences.
  • Bladder conservation therapy may be offered to selected patients with BC recurrences as an alternative option to radical cystectomy, and its use should be limited to teams of uro-oncologists, experienced in multi-modalty treatment.

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  • (PMID = 12161935.001).
  • [ISSN] 1124-3562
  • [Journal-full-title] Archivio italiano di urologia, andrologia : organo ufficiale [di] Societa italiana di ecografia urologica e nefrologica
  • [ISO-abbreviation] Arch Ital Urol Androl
  • [Language] ENG
  • [Publication-type] Journal Article
  • [Publication-country] Italy
  • [Chemical-registry-number] 0 / BCG Vaccine; 5V9KLZ54CY / Vinblastine; 80168379AG / Doxorubicin; Q20Q21Q62J / Cisplatin; YL5FZ2Y5U1 / Methotrexate
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18. Au JL, Badalament RA, Wientjes MG, Young DC, Warner JA, Venema PL, Pollifrone DL, Harbrecht JD, Chin JL, Lerner SP, Miles BJ, International Mitomycin C Consortium: Methods to improve efficacy of intravesical mitomycin C: results of a randomized phase III trial. J Natl Cancer Inst; 2001 Apr 18;93(8):597-604
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  • [Title] Methods to improve efficacy of intravesical mitomycin C: results of a randomized phase III trial.
  • BACKGROUND: Intravesical chemotherapy (i.e., placement of the drug directly in the bladder) with mitomycin C is beneficial for patients with superficial bladder cancer who are at high risk of recurrence, but standard therapy is empirically based and patient response rates have been variable, in part because of inadequate drug delivery.
  • We carried out a prospective, two-arm, randomized, multi-institutional phase III trial to test whether enhancing the drug's concentration in urine would improve its efficacy.
  • METHODS: Patients with histologically proven transitional cell carcinoma and at high risk for recurrence were eligible for the trial.
  • Patients in the optimized-treatment arm (n = 119) received a 40-mg dose of mitomycin C, pharmacokinetic manipulations to increase drug concentration by decreasing urine volume, and urine alkalinization to stabilize the drug.
  • Patients in the standard-treatment arm (n = 111) received a 20-mg dose without pharmacokinetic manipulations or urine alkalinization.
  • Both treatments were given weekly for 6 weeks.
  • Primary endpoints were recurrence and time to recurrence.
  • Treatment outcome was examined by use of Kaplan-Meier analysis with log-rank tests.
  • RESULTS: Patients in the two arms did not differ in demographics or history of intravesical therapy.
  • Dysuria occurred more frequently in the optimized arm but did not lead to more frequent treatment termination.
  • In an intent-to-treat analysis, patients in the optimized arm showed a longer median time to recurrence (29.1 months; 95% confidence interval [CI] = 14.0 to 44.2 months) and a greater recurrence-free fraction (41.0%; 95% CI = 30.9% to 51.1%) at 5 years than patients in the standard arm (11.8 months; 95% CI = 7.2 to 16.4 months) and 24.6% (95% CI = 14.9% to 34.3%) (P =.005, log-rank test for time to recurrence).
  • Improvements were found in all risk groups defined by tumor stage, grade, focality, and recurrence.
  • CONCLUSIONS: This study identified a pharmacologically optimized intravesical mitomycin C treatment with statistically significantly enhanced efficacy.
  • [MeSH-major] Antibiotics, Antineoplastic / administration & dosage. Carcinoma, Transitional Cell / drug therapy. Mitomycin / administration & dosage. Urinary Bladder Neoplasms / drug therapy

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  • [CommentIn] J Natl Cancer Inst. 2001 Apr 18;93(8):572-3 [11309425.001]
  • [CommentIn] J Natl Cancer Inst. 2001 Oct 17;93(20):1574-5 [11604485.001]
  • (PMID = 11309436.001).
  • [ISSN] 0027-8874
  • [Journal-full-title] Journal of the National Cancer Institute
  • [ISO-abbreviation] J. Natl. Cancer Inst.
  • [Language] eng
  • [Grant] United States / NCI NIH HHS / CA / R01 CA58983; United States / NCI NIH HHS / CA / R01 CA58988; United States / NCI NIH HHS / CA / R01 CA58989
  • [Publication-type] Clinical Trial; Clinical Trial, Phase III; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, U.S. Gov't, P.H.S.
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Antibiotics, Antineoplastic; 50SG953SK6 / Mitomycin
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19. Addeo R, Caraglia M, Bellini S, Abbruzzese A, Vincenzi B, Montella L, Miragliuolo A, Guarrasi R, Lanna M, Cennamo G, Faiola V, Del Prete S: Randomized phase III trial on gemcitabine versus mytomicin in recurrent superficial bladder cancer: evaluation of efficacy and tolerance. J Clin Oncol; 2010 Feb 1;28(4):543-8
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  • [Title] Randomized phase III trial on gemcitabine versus mytomicin in recurrent superficial bladder cancer: evaluation of efficacy and tolerance.
  • PURPOSE: Approximately 30% to 40% patients with a superficial bladder cancer treated with Bacille Calmette-Guerin (BCG) or epirubicin do not respond; of the initial responders, 35% have a relapse within 5 years.
  • We compare the therapeutic efficacy and toxicity of intravescical infusions of gemcitabine (GEM) with mitomycin (MMC) in patients with a recurrent superficial bladder cancer.
  • PATIENTS AND METHODS: Patients with a history of a previously treated, recurrent Ta-T1, G1-G3 bladder transitional cell carcinoma were enrolled in the study.
  • In both arms, for the initial responders who remained free of recurrences, maintenance therapy consisted of 10 monthly treatments during the first year.
  • RESULTS: A total of 120 patients were enrolled and randomly assigned to either the MMC or GEM treatment arm.
  • Among patients with recurrences, 10 in the MMC arm and six in the GEM arm also had a progressive disease by stage.
  • CONCLUSION: This study demonstrates that GEM has better efficacy and lower toxicity than MMC; therefore, GEM appears as a logical candidate for intrabladder therapy in patients with refractory transitional cancer.
  • [MeSH-major] Antibiotics, Antineoplastic / therapeutic use. Antimetabolites, Antineoplastic / therapeutic use. Carcinoma, Transitional Cell / drug therapy. Deoxycytidine / analogs & derivatives. Mitomycin / therapeutic use. Neoplasm Recurrence, Local / drug therapy. Urinary Bladder Neoplasms / drug therapy
  • [MeSH-minor] Aged. Female. Humans. Male. Maximum Tolerated Dose. Neoplasm Staging. Prognosis. Survival Rate. Treatment Outcome


20. Lehmann J, Retz M, Wiemers C, Beck J, Thüroff J, Weining C, Albers P, Frohneberg D, Becker T, Funke PJ, Walz P, Langbein S, Reiher F, Schiller M, Miller K, Roth S, Kälble T, Sternberg D, Wellek S, Stöckle M, AUO-AB 05/95: Adjuvant cisplatin plus methotrexate versus methotrexate, vinblastine, epirubicin, and cisplatin in locally advanced bladder cancer: results of a randomized, multicenter, phase III trial (AUO-AB 05/95). J Clin Oncol; 2005 Aug 1;23(22):4963-74
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  • [Title] Adjuvant cisplatin plus methotrexate versus methotrexate, vinblastine, epirubicin, and cisplatin in locally advanced bladder cancer: results of a randomized, multicenter, phase III trial (AUO-AB 05/95).
  • PURPOSE: Radical cystectomy as standard treatment of muscle-invasive urothelial carcinoma of the urinary bladder cures less than 50% of patients with locally advanced bladder cancer.
  • We compared two adjuvant combination chemotherapies in patients with stage pT3a-4a and/or pathologic node-positive transitional-cell carcinoma of the bladder after radical cystectomy.
  • PATIENTS AND METHODS: A total of 327 patients were randomly assigned to either adjuvant systemic chemotherapy with three cycles of cisplatin 70 mg/qm(2) on day 1 and methotrexate 40 mg/qm(2) on days 8 and 15 of a 21-day cycle (CM) or three cycles of methotrexate 30 mg/qm(2) on days 1, 15, and 22, vinblastine 3 mg/qm(2) on days 2, 15, and 22, epirubicin 45 mg/qm(2) on day 2, and cisplatin 70 mg/qm(2) on day 2 of a 28-day cycle (M-VEC).
  • The 5-year progression-free, tumor-specific, and overall survival rates (point estimates +/- SE) for CM versus M-VEC were 46.3% +/- 4.6% v 48.8% +/- 4.5%, 52.0% +/- 4.6% v 52.3% +/- 4.8%, and 46.1% +/- 4.3% v 45.1% +/- 4.6%, respectively.
  • WHO grade 3 and 4 leukopenia occurred in 7.0% of patients treated with CM and 22.2% of patients treated with M-VEC (P < .0001).
  • CONCLUSION: CM cannot be considered inferior to M-VEC with regard to progression-free survival of patients with locally advanced bladder cancer after radical cystectomy.
  • Moreover, patients receiving adjuvant CM combination therapy experienced significantly less grade 3 and 4 leukopenia than patients treated with M-VEC.
  • [MeSH-major] Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Urinary Bladder Neoplasms / drug therapy
  • [MeSH-minor] Adult. Aged. Cisplatin / administration & dosage. Disease Progression. Epirubicin / administration & dosage. Female. Humans. Male. Methotrexate / administration & dosage. Middle Aged. Survival Analysis. Treatment Outcome. Vinblastine / administration & dosage

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  • [CommentIn] J Clin Oncol. 2005 Aug 1;23(22):4823-6 [15939919.001]
  • (PMID = 15939920.001).
  • [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] Clinical Trial; Clinical Trial, Phase III; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
  • [Publication-country] United States
  • [Chemical-registry-number] 3Z8479ZZ5X / Epirubicin; 5V9KLZ54CY / Vinblastine; Q20Q21Q62J / Cisplatin; YL5FZ2Y5U1 / Methotrexate; M-VEC protocol
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21. von der Maase H, Hansen SW, Roberts JT, Dogliotti L, Oliver T, Moore MJ, Bodrogi I, Albers P, Knuth A, Lippert CM, Kerbrat P, Sanchez Rovira P, Wersall P, Cleall SP, Roychowdhury DF, Tomlin I, Visseren-Grul CM, Conte PF: Gemcitabine and cisplatin versus methotrexate, vinblastine, doxorubicin, and cisplatin in advanced or metastatic bladder cancer: results of a large, randomized, multinational, multicenter, phase III study. J Clin Oncol; 2000 Sep;18(17):3068-77
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  • [Title] Gemcitabine and cisplatin versus methotrexate, vinblastine, doxorubicin, and cisplatin in advanced or metastatic bladder cancer: results of a large, randomized, multinational, multicenter, phase III study.
  • PURPOSE: Gemcitabine plus cisplatin (GC) and methotrexate, vinblastine, doxorubicin, and cisplatin (MVAC) were compared in patients with locally advanced or metastatic transitional-cell carcinoma (TCC) of the urothelium.
  • PATIENTS AND METHODS: Patients with stage IV TCC and no prior systemic chemotherapy were randomized to GC (gemcitabine 1,000 mg/m2 days 1, 8 and 15; cisplatin 70 mg/m2 day 2) or standard MVAC every 28 days for a maximum of six cycles.
  • Overall survival was similar on both arms (hazards ratio [HR], 1.04; 95% confidence interval [CI], 0.82 to 1.32; P = .75), as were time to progressive disease (HR, 1.05; 95% CI, 0.85 to 1.30), time to treatment failure (HR, 0.89; 95% CI 0.72 to 1.10), and response rate (GC, 49%; MVAC, 46%).
  • More GC patients completed six cycles of therapy, with fewer dose adjustments.
  • Quality of life was maintained during treatment on both arms; however, more patients on GC fared better regarding weight, performance status, and fatigue.
  • CONCLUSION: GC provides a similar survival advantage to MVAC with a better safety profile and tolerability.
  • [MeSH-major] Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Carcinoma, Transitional Cell / drug therapy. Deoxycytidine / analogs & derivatives. Urinary Bladder Neoplasms / drug therapy
  • [MeSH-minor] Anti-Infective Agents / therapeutic use. Cisplatin / administration & dosage. Cisplatin / adverse effects. Doxorubicin / administration & dosage. Doxorubicin / adverse effects. Female. Granulocyte Colony-Stimulating Factor / therapeutic use. Granulocyte-Macrophage Colony-Stimulating Factor / therapeutic use. Hospitalization. Humans. Male. Methotrexate / administration & dosage. Methotrexate / adverse effects. Middle Aged. Neoplasm Metastasis. Neoplasm Staging. Prognosis. Quality of Life. Survival Analysis. Vinblastine / administration & dosage. Vinblastine / adverse effects

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  • [CommentIn] J Clin Oncol. 2001 Feb 15;19(4):1229-31 [11181690.001]
  • (PMID = 11001674.001).
  • [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] Clinical Trial; Clinical Trial, Phase III; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Anti-Infective Agents; 0W860991D6 / Deoxycytidine; 143011-72-7 / Granulocyte Colony-Stimulating Factor; 5V9KLZ54CY / Vinblastine; 80168379AG / Doxorubicin; 83869-56-1 / Granulocyte-Macrophage Colony-Stimulating Factor; B76N6SBZ8R / gemcitabine; Q20Q21Q62J / Cisplatin; YL5FZ2Y5U1 / Methotrexate; M-VAC protocol
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22. Waidelich R, Beyer W, Knüchel R, Stepp H, Baumgartner R, Schröder J, Hofstetter A, Kriegmair M: Whole bladder photodynamic therapy with 5-aminolevulinic acid using a white light source. Urology; 2003 Feb;61(2):332-7
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  • [Title] Whole bladder photodynamic therapy with 5-aminolevulinic acid using a white light source.
  • OBJECTIVES: To determine whether whole bladder photodynamic therapy after intravesical administration of 5-aminolevulinic acid using a white light source would destroy urothelial carcinoma.
  • We sought to define the optimal target group of patients for this therapy.
  • The side effects of treatment were also assessed.
  • METHODS: We performed whole bladder photodynamic therapy with 100 J/cm(2) white light 2 to 4.5 hours after intravesical administration of 17% 5-aminolevulinic acid in 12 patients with recurring, multifocal, Stage pTa, grade I to III, urothelial tumors of the bladder and carcinoma in situ.
  • RESULTS: Immediately after whole bladder irradiation, histologic examination of biopsies taken from flat suspicious lesions showed no viable cells; remnants of malignant cells were found in papillary tumors.
  • At a median follow-up of 18 months (range 3 to 25), 3 of the 7 patients with carcinoma in situ and 2 of the 4 patients with papillary tumors were free of disease.
  • In all patients, urinary frequency and urgency subsided within 3 weeks.
  • No decreased bladder capacity or systemic side effects were observed.
  • CONCLUSIONS: Our preliminary data show that whole bladder photodynamic therapy with intravesically applied 5-aminolevulinic acid using a white light source is effective in destroying flat malignant lesions of the bladder such as carcinoma in situ.
  • The procedure is easy to perform and is not associated with any major side effects.
  • [MeSH-major] Aminolevulinic Acid / therapeutic use. Carcinoma, Transitional Cell / drug therapy. Photochemotherapy / methods. Photosensitizing Agents / therapeutic use. Urinary Bladder Neoplasms / drug therapy
  • [MeSH-minor] Administration, Intravesical. Biopsy. Carcinoma in Situ / drug therapy. Carcinoma in Situ / pathology. Follow-Up Studies. Humans. Treatment Outcome

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  • (PMID = 12597941.001).
  • [ISSN] 1527-9995
  • [Journal-full-title] Urology
  • [ISO-abbreviation] Urology
  • [Language] eng
  • [Publication-type] Clinical Trial; Journal Article; Research Support, Non-U.S. Gov't
  • [Publication-country] United States
  • [Chemical-registry-number] 0 / Photosensitizing Agents; 88755TAZ87 / Aminolevulinic Acid
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23. Gontero P, Casetta G, Maso G, Sogni F, Pretti G, Zitella A, Frea B, Tizzani A: Phase II study to investigate the ablative efficacy of intravesical administration of gemcitabine in intermediate-risk superficial bladder cancer (SBC). Eur Urol; 2004 Sep;46(3):339-43
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  • [Title] Phase II study to investigate the ablative efficacy of intravesical administration of gemcitabine in intermediate-risk superficial bladder cancer (SBC).
  • New treatment options are needed for intermediate-risk SBC recurring after conventional intravesical treatments.
  • METHODS: The study was designed as a two-stage phase II trial, with a sample size of 39 patients.
  • The efficacy of intravesical Gemcitabine at a concentration of 40 mg/ml (2000 mg in 50 ml saline solution) administered weekly for 6 weeks was assessed on a single marker tumour left in the bladder after a complete TUR of all other lesions.
  • Patients underwent TUR or biopsy at the site of the marker lesion 2 weeks after completion of the treatment.
  • CONCLUSION: The ablative effect of Gemcitabine produced a higher number of responses than the minimum required by the protocol to indicate a significant probability of drug efficacy.
  • It is worth testing the drug in phase III trials to assess for durability of response.
  • [MeSH-major] Antimetabolites, Antineoplastic / administration & dosage. Carcinoma, Transitional Cell / drug therapy. Deoxycytidine / administration & dosage. Deoxycytidine / analogs & derivatives. Urinary Bladder Neoplasms / drug therapy
  • [MeSH-minor] Administration, Intravesical. Aged. Female. Humans. Male. Middle Aged. Remission Induction. Treatment Outcome

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  • (PMID = 15306105.001).
  • [ISSN] 0302-2838
  • [Journal-full-title] European urology
  • [ISO-abbreviation] Eur. Urol.
  • [Language] eng
  • [Publication-type] Clinical Trial; Clinical Trial, Phase II; Journal Article
  • [Publication-country] Netherlands
  • [Chemical-registry-number] 0 / Antimetabolites, Antineoplastic; 0W860991D6 / Deoxycytidine; B76N6SBZ8R / gemcitabine
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24. Hobdy EM, Ciesielski TE, Kummar S: Unusual sites of colorectal cancer metastasis. Clin Colorectal Cancer; 2003 May;3(1):54-7
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  • We present 2 separate cases of adenocarcinoma of the colon with metastasis to the chin and the bladder, both of which are unusual sites of colorectal cancer metastasis.
  • Patient 1 is a 77-year-old man who was diagnosed with adenocarcinoma of the colon, American Joint Committee on Cancer (AJCC) T4 N0 M0 (stage II), and underwent a right hemicolectomy.
  • Fourteen months later he developed a firm 2.5-cm mass involving the chin.
  • Patient 2 is a 75-year-old man who was diagnosed with AJCC T3 N1 M0 (stage III) adenocarcinoma of the colon and underwent sigmoid colectomy.
  • Ten years later, he was found to have transitional cell carcinoma involving retroperitoneal nodes with no identifiable bladder or ureteral primary, for which he received chemotherapy.
  • Eighteen months following this diagnosis, he developed hematuria and was found to have metastatic colon adenocarcinoma involving the bladder.
  • [MeSH-major] Adenocarcinoma / diagnosis. Adenocarcinoma / secondary. Colorectal Neoplasms / diagnosis. Colorectal Neoplasms / pathology. Urinary Bladder Neoplasms / diagnosis. Urinary Bladder Neoplasms / secondary

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  • (PMID = 12777193.001).
  • [ISSN] 1533-0028
  • [Journal-full-title] Clinical colorectal cancer
  • [ISO-abbreviation] Clin Colorectal Cancer
  • [Language] eng
  • [Publication-type] Case Reports; Journal Article
  • [Publication-country] United States
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25. Goel MC, Mahendra V, Roberts JG: Percutaneous management of renal pelvic urothelial tumors: long-term followup. J Urol; 2003 Mar;169(3):925-9; discussion 929-30
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  • [Title] Percutaneous management of renal pelvic urothelial tumors: long-term followup.
  • PURPOSE: We present the long-term outcome of percutaneous resection of renal urothelial tumor.
  • MATERIALS AND METHODS: A total of 24 patients underwent primary percutaneous resection of renal urothelial tumor.
  • Patients with low stage pT0-1 disease were treated primarily with percutaneous surgery.
  • Patients with multi-segmental pelvicaliceal system involvement, stage greater than pT1, high grade histology or additional ureteral tumors were considered for nephroureterectomy.
  • Topical chemotherapy (mitomycin C or epirubicin) was administered via nephrostomy tube or intravesical instillation after Double-J stent (Medical Engineering Corp., New York, New York) insertion.
  • RESULTS: Of the 24 cases 2 had squamous cell carcinoma, 5 had grade III transitional cell carcinoma, 15 had grade I to II transitional cell carcinoma and 2 had no tumor.
  • Early recurrences were detected by excretory urography (IVP) in 3 cases, small pelvic recurrences by IVP in 2, fiberoptic ureterorenoscopy in 2 and bladder tumors by flexible cystoscopy in 3 after 1 year.
  • Three synchronous, grade I bladder tumors were managed conventionally.
  • All patients with high grade disease died of malignancy except one (with no further treatment) and 6 of the 15 patients with low grade noninvasive transitional cell carcinoma underwent nephroureterectomy during followup either due to progression of disease, concomitant tumor or complications.
  • CONCLUSIONS: Percutaneous resection of transitional cell tumor should be considered primarily in patients with early stage disease excluding tumors crossing caliceal infundibula, ureteropelvic junction tumor, tumor extending over multiple calices and synchronous ureteral tumors.
  • [MeSH-major] Carcinoma, Transitional Cell / therapy. Kidney Neoplasms / therapy
  • [MeSH-minor] Aged. Aged, 80 and over. Antineoplastic Combined Chemotherapy Protocols / therapeutic use. Carcinoma, Squamous Cell / therapy. Endoscopy. Female. Follow-Up Studies. Humans. Kidney Pelvis. Male. Middle Aged. Neoplasm Recurrence, Local. Nephrectomy. Ureter / surgery

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  • [CommentIn] J Urol. 2003 Mar;169(3):936-7 [12576816.001]
  • (PMID = 12576814.001).
  • [ISSN] 0022-5347
  • [Journal-full-title] The Journal of urology
  • [ISO-abbreviation] J. Urol.
  • [Language] eng
  • [Publication-type] Journal Article
  • [Publication-country] United States
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