Weekly gemcitabine and cisplatin combination therapy in patients with transitional cell carcinoma of the urothelium: A phase II clinical trial

Purpose: To determine the efficacy of gemcitabine and cisplatin combination therapy in patients with advanced and/or metastatic transitional cell urot helial carcinoma. Patients and methods: Forty-two chemonaive patients with Karnofsky performa nce status (KPS) greater than or equal to 70 were treated with cisplatin 35 mg/m(2) followed by gemcitabine 1000 mg/m(2) (30 min i.v. infusion) on day s 1, 8, and 15 every twenty-eight days. Results: Thirty-eight patients were evaluable for efficacy. Half had viscer al disease. There were seven complete (18%) and nine partial responses (24% ), for a response rate of 42% (95% confidence interval (95% CI): 26%-59%). Responses were independently reviewed. Median response duration was 13.5 mo nths (95% CI: 8.5-18.1 months), median time to progressive disease 7.2 mont hs (95% CI: 4.0-9.1 months) and median survival 12.5 months (95% CI: 8.1-18 .7 months); one-year survival was 52%. Laboratory toxicities included leuco penia (44% grade 3; 17% grade 4), neutropenia (25% grade 3; 33% grade 4) an d thrombocytopenia (29% grade 3; 49% grade 4). Four patients had grade 4 sy mptomatic toxicity (three nausea and vomiting, one diarrhoea). There were n o grade 4 infections and no toxic deaths. Conclusions: The combination of gemcitabine and cisplatin is active in pati ents with locally advanced and/or metastatic urothelial carcinoma. The week ly schedule of cisplatin is considered inappropriate.