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Topotecan in previously treated advanced urothelial carcinoma: an ECOG phase II trial
Background:
[corrected] 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 (i.v.) 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 and 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.
Insights
Topotecan showed minimal activity in advanced urothelial carcinoma patients previously treated with chemotherapy. While toxicities like gastrointestinal issues and myelosuppression were noted, they were manageable, and no treatment-related deaths occurred.
Area of Science:
- Oncology
- Pharmacology
Background:
- Chemotherapy is crucial for urothelial carcinoma.
- New agents and their toxicity profiles are needed.
- Topotecan's efficacy in bladder cancer was unstudied.
Purpose of the Study:
- To evaluate topotecan's activity in advanced urothelial carcinoma.
- To assess the toxicity of topotecan in this patient population.
Main Methods:
- 44 ambulatory patients with advanced urothelial carcinoma received topotecan (1.5 mg/m2 i.v. daily for 5 days every 3 weeks for 6 cycles).
- Dose modifications were implemented for specific toxicities (leukopenic fever, thrombocytopenic bleeding, grade 3/4 NCI toxicity).
Main Results:
- Overall response rate was 9.1% (4 partial responses).
- Common toxicities included gastrointestinal issues and myelosuppression.
- No treatment-related deaths were reported.
Conclusions:
- Topotecan demonstrated minimal activity in previously treated advanced urothelial carcinoma.
- Identified toxicities were severe but manageable with dose adjustments.
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