Abstract | PURPOSE: The aim of this phase II study was to determine the efficacy of gemcitabine administered as an intravesical agent in patients with bacille Calmette-Guérin (BCG) -refractory transitional cell carcinoma of the bladder. PATIENTS AND METHODS: Patients with superficial bladder cancer refractory or intolerant to intravesical BCG therapy and refusing a cystectomy were considered eligible for the trial. Eligible patients received two courses of intravesical gemcitabine twice weekly at a dose of 2,000 mg/100 mL for 3 consecutive weeks, with each course separated by 1 week of rest. Patients were evaluated for response at 8 weeks, then every 3 months to 1 year. RESULTS: Thirty eligible patients were included on study. The median follow-up for all the patients was 19 months (range, 0 to 35 months). Of the 30 patients, 15 (50%; 95% CI, 32% to 68%) achieved a complete response (CR). Twelve patients had tumor recurrence with a median recurrence-free survival time of 3.6 months (95% CI, 2.9 to 11.0 months). Two patients maintained a CR at 23 and 29 months, respectively. The 1-year recurrence-free survival rate for patients with a CR was 21% (95% CI, 0% to 43%). Two patients progressed to a higher stage while receiving gemcitabine treatment. The median follow-up for patients who did not have a progression or a cystectomy was 19 months (range, 2 to 35 months). Eleven patients (37%) underwent a cystectomy subsequent to gemcitabine therapy. CONCLUSION:
Gemcitabine has activity in a high-risk patient population and remains a viable option for some patients who refuse cystectomy.
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Authors | Guido Dalbagni, Paul Russo, Bernard Bochner, Leah Ben-Porat, Joel Sheinfeld, Pramod Sogani, Machelle S Donat, Harry W Herr, Dean Bajorin |
Journal | Journal of clinical oncology : official journal of the American Society of Clinical Oncology
(J Clin Oncol)
Vol. 24
Issue 18
Pg. 2729-34
(Jun 20 2006)
ISSN: 1527-7755 [Electronic] United States |
PMID | 16782913
(Publication Type: Clinical Trial, Phase II, Journal Article, Research Support, Non-U.S. Gov't)
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Chemical References |
- Antimetabolites, Antineoplastic
- BCG Vaccine
- Deoxycytidine
- Gemcitabine
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Topics |
- Administration, Intravesical
- Adult
- Aged
- Aged, 80 and over
- Antimetabolites, Antineoplastic
(administration & dosage)
- BCG Vaccine
(therapeutic use)
- Carcinoma, Transitional Cell
(drug therapy)
- Deoxycytidine
(administration & dosage, analogs & derivatives)
- Disease-Free Survival
- Female
- Humans
- Male
- Middle Aged
- Remission Induction
- Urinary Bladder Neoplasms
(drug therapy)
- Gemcitabine
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