Phase II study of cisplatin and paclitaxel in advanced carcinoma of the urothelium: An Eastern Cooperative Oncology Group study

Purpose: Cisplatin and paclitaxel are active agents in advanced urothelial cancer. A phase II trial of this combination was performed to determine the activity and toxicity of these agents in a multi-institutional setting. Patients and Methods: Fifty-two patients with advanced urothelial carcinoma were treated on one day with paclitaxel 175 mg/m(2) over 3 hours followed by cisplatin 75 mg/m(2), both intravenously, every 21 days. Cycles were rep eated every 21 days until progression or a. maximum of six cycles. Results: Twenty-six patients obtained an objective response, for an overall response rate of 50% (95% confidence interval, 36% to 64%), Four patients achieved complete clinical responses. The median overall survival time for the group was 10.6 months. Toxicity was moderate, with granulocytopenia and neurotoxicity being the most common side effects noted. Conclusion: The combination of cisplatin and paclitaxel is active in advanc ed urothelial cancer. Responses in visceral, nodal, and soft tissues sites were observed. Granulocytopenia without fever and grade 2/3 neuro-toxicity were common. The confidence interval of the overall response rate in this s tudy overlaps most of the other reported regimens. The optimal therapy for advanced urothelial cancer remains undefined. J Clin Oncol 18:1058-1061. (C ) 2000 by American Society of Clinical Oncology.