TOPOTECAN IN PREVIOUSLY TREATED ADVANCED UROTHELIAL CARCINOMA - AN ECOG PHASE-II TRIAL

Background: Chemotherapeutic agents are playing an increasing role in the management of urothelial carcinoma. Despite recent advances in the treatment of this disease there continues to be a need to identify ne w active agents and their toxicity spectra. Topotecan is an agent as y et unstudied in bladder cancer. Methods: Ambulatory patients with prog ressive advanced urothelial carcinoma following prior systemic chemoth erapy were treated with topotecan 1.5 mg/m(2) intravenously (IV) daily for 5 days every three weeks for 6 cycles. Doses were modified for le ukopenic fever, thrombocytopenic bleeding, and any grade 3 or 4 (NCI c ommon toxicity criteria) toxicity. Results: Forty-four eligible patien ts entered the trial. There were 4 partial responses for an overall re sponse rate of 9.1% (exact 95% two-stage binomial CI, 2.9% to 25.5%). Major identified toxicities were gastrointestinal and myelosuppression . There were no treatment-related deaths. Conclusions: Topotecan at th is dose and schedule has minimal activity in previously treated patien ts with advanced urothelial carcinoma. Toxicities can be seven but are manageable.