Abstract
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 new active agents and their toxicity spectra. Topotecan is an agent as yet unstudied in bladder cancer.
Methods: Ambulatory patients with progressive advanced urothelial carcinoma following prior systemic chemotherapy were treated with topotecan 1.5 mg/m2 intravenously (IV) daily for 5 days every three weeks for 6 cycles. Doses were modified for leukopenic fever, thrombocytopenic bleeding, and any grade 3 or 4 (NCI common toxicity criteria) toxicity.
Results: Forty-four eligible patients entered the trial. There were 4 partial responses for an overall response rate of 9.1% (exact 95% two-stage binomial CI, 2.9% to 25.5%). Major identified toxicities were gastrointestinal nd myelosuppression. There were no treatment-related deaths.
Conclusions: Topotecan at this dose and schedule has minimal activity in previously treated patients with advanced urothelial carcinoma. Toxicities can be severe but are manageable.
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Witte, R.S., Manola, J., Burch, P.A. et al. Topotecan in previously treated advanced urothelial carcinoma: an ECOG phase II trial. Invest New Drugs 16, 191–195 (1998). https://doi.org/10.1023/A:1006159525793
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DOI: https://doi.org/10.1023/A:1006159525793