Purpose: To evaluate the activity and toxicity of gemcitabine and carboplatin in consecutive patients presenting with locally advanced or metastatic transitional cell carcinoma of the urothelium (TCC).
Patients and methods: Seventeen consecutive patients referred to a single institution with locally advanced or metastatic TCC were treated with carboplatin AUC 5 on day 1 and gemcitabine 1000 mg/m2 on day 1 and 8 of a 21-day cycle. All patients were assessable for response and toxicity. Minimal eligibility 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 creatinine clearance was 56 ml/min (range 34-90) and 30% of patients had an ECOG performance score of two. Nine patients (53%) had visceral metastases and the majority of patients had multiple sites of metastases. There were three complete responses, seven partial responses, for an overall response rate of 58.8%. Responses were seen at all sites including the liver. One patient had a response within a previously irradiated field and three patients with prior chemotherapy had responses. Median overall survival was 10.5 months and median time to progression was 4.6 months. Toxicity was primarily haematologic with six patients having grade 3 neutropenia and six patients with grade 4 neutropenia. There were five cases of grade 3 and three cases of grade 4 thrombocytopenia. There were no episodes of febrile neutropenia and only one patient required admission for management of toxicity. Thirteen patients required dose reduction or delay due to neutropenia or thrombocytopenia. There were no treatment-related deaths.
Conclusion: The combination of carboplatin and gemcitabine is active in metastatic transitional cell carcinoma of the urothelium with manageable toxicity in a relatively elderly group of patients with some poor prognostic features.