BACKGROUND Cisplatin‐based combinations are considered to be the standard treatment for advanced transitional cell carcinoma (TCC) of the urothelium. Many of the patients are elderly with concomitant diseases or impaired renal function. We studied the tolerance and activity of the gemcitabine/carboplatin combination as a therapeutic alternative. METHODS Patients with locally advanced or metastatic TCC of the urothelium were treated with gemcitabine 1000 mg/m2 on Days 1 and 8 and carboplatin area under the concentration‐time curve 5 on Day 1 every 21 days. Patients with creatinine clearance of 30 mL/min or above and Karnofsky performance status (KPS) scores 60 or above were enrolled. RESULTS A total of 227 cycles were administered to 41 patients, with an average of 5.5 cycles per patient (range, 1–8 cycles). Creatinine clearance was below 60 mL/min in 54% of patients, KPS was 70 or below in 37% of patients, and 37% of patients were 70 years old or older. Hematologic toxicity was mainly Grade 3/4 neutropenia in 63%, Grade 3/4 thrombocytopenia in 32%, and Grade 3/4 anemia in 54% of patients. There were only three episodes of febrile neutropenia and one death from neutropenic sepsis. Nonhematologic toxicity was mild, with asthenia as the most frequently reported event. We obtained 6 complete and 17 partial responses, for an overall response rate of 56.1% (95% confidence interval [CI], 40.6–71.6%). Progression‐free survival was 7.2 months (95% CI, 5.7–8.5) and median survival was 10.1 months (95% CI, 8.8–12.2). CONCLUSIONS The combination of gemcitabine plus carboplatin achieves a similar result to doublets using cisplatin. It has an acceptable toxicity profile and enables patients with impaired renal function and/or poor performance status and elderly patients to be treated. Cancer 2003;97:2180–6. © 2003 American Cancer Society. DOI 10.1002/cncr.10990

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