Phase II trial of intravesical gemcitabine in bacille Calmette-Guérin-refractory transitional cell carcinoma of the bladder.

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.

• 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)

Chemical References

• Antimetabolites, Antineoplastic
• BCG Vaccine
• Deoxycytidine
• Gemcitabine

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