Carboplatin and gemcitabine in metastatic transitional cell carcinoma of the urothelium: Effective treatment of patients with poor prognostic features

Purpose: To evaluate the activity and toxicity of gemcitabine and carboplat in in consecutive patients presenting with locally advanced or metastatic t ransitional cell carcinoma of the urothelium (TCC). Patients and methods: Seventeen consecutive patients referred to a single i nstitution with locally advanced or metastatic TCC were treated with carbop latin AUC 5 on day 1 and gemcitabine 1000 mg/m(2) on day 1 and 8 of a 21-da y cycle. All patients were assessable for response and toxicity. Minimal el igibility criteria were used to minimize patient selection. Results: Seventeen patients with measurable stage IV TCC of the urothelium were treated. The median age was 69 years (range 54-78), the median creatin ine clearance was 56 ml/min (range 34-90) and 30% of patients had an ECOG p erformance score of two. Nine patients (53%) had visceral metastases and th e majority of patients had multiple sites of metastases. There were three c omplete responses, seven partial responses, for an overall response rate of 58.8%. Responses were seen at all sites including the liver. One patient h ad a response within a previously irradiated field and three patients with prior chemotherapy had responses. Median overall survival was 10.5 months a nd median time to progression was 4.6 months. Toxicity was primarily haemat ologic with six patients having grade 3 neutropenia and six patients with g rade 4 neutropenia. There were five cases of grade 3 and three cases of gra de 4 thrombocytopenia. There were no episodes of febrile neutropenia and on ly one patient required admission for management of toxicity. Thirteen pati ents required dose reduction or delay due to neutropenia or thrombocytopeni a. There were no treatment-related deaths. Conclusion: The combination of carboplatin and gemcitabine is active in met astatic transitional cell carcinoma of the urothelium with manageable toxic ity in a relatively elderly group of patients with some poor prognostic fea tures.