Carboplatin and gemcitabine in patients with advanced and/or metastatic urothelial cancers: A phase II study

Objectives: The primary objective of this study was to determine the response rate of the combination carboplatin and gemcitabine in patients with advanced and/or metastatic transitional cell carcinoma (TCC). The secondary objective was to evaluate the safety profile and overall survival. Patients and methods: Patients were treated with gemcitabine 1000 mg/m(2) on days 1 and 8 and carboplatin area under the concentration-time curve 5 on day 1 every 21 days. Results: 23 patients were included onto the trial. 18 patients were included for response analysis: 1 patient (5.6%) showed a complete response and 7 patients (38.9%) achieved a partial response for an overall response rate of 44.4% (95% Confidence Interval (CI): 21.5%-67.4%) with a median overall survival of 5.2 months (95% CI: 0-10.8 months). Stable disease was observed in 6 patients and progressive disease in 4 patients. The response rate and median survival for the intent to treat population were respectively 34.8% (95% CI: 14.6-53.4%) and 3.3 months (95% CI: 0-6.9 months). Grades 3 and 4 anaemia, thrombocytopenia and neutropenia were observed respectively in 9, 13, and 11 patients. Grades 3 and 4 non-haematological toxicities were fatigue in 2 patients, renal failure in 2 patients, pain in 2 patients, haematuria in 2 patients and 8 patients developed infectious complications. There was 1 toxic death. Conclusion: The gemcitabine plus carboplatin combination is active and has a manageable toxicity in patients with advanced and/or metastatic TCC. A global geriatric assessment is recommended to identify patients who would not benefit from intensive chemotherapy. (C) 2010 Elsevier Ltd. All rights reserved.