Carboplatin-gemcitabine treatment of patients with transitional cell carcinoma of the bladder and impaired renal function.

INTRODUCTION: Bladder cancer is a frequently occurring tumour in Spain and usually affects elderly patients with renal impairment. The development of new combination therapies for such patients is thus of vital importance. PATIENTS AND METHODS: Between 1997 and 1998, 17 patients with locally advanced non-surgical or metastatic bladder tumours were treated at our centres. Treatment consisted of 1,000 mg/m(2) of gemcitabine administered on days 1 and 8, and carboplatin (area under the concentration curve = 5) on day 1, every 21 days.
RESULTS: The mean age of the patients [4 females (26%) and 13 males] was 69 years (range: 54-78 years). The average Karnofsky performance status was 80% (range: 50-100%). Mean creatinine clearance was 45.4 ml/min (range: 21-55 ml/min). There were 2 complete responses, 7 partial responses (RO: 56%; range 31-81%), 6 patients had stable disease and 1 disease progression. Haematological toxicities were as follows: grade I anaemia in 2 patients, grade III in 3; grade I granulocytopenia in 2 patients, grade III-IV in 4 patients; grade III thrombocytopenia in 3 patients. Toxic death occurred in the course of one grade IV neutropenic event. Non-haematological toxicities were as follows: grade I-II vomiting in 3 patients and grade III in 1. One patient had grade III hepatic toxicity. One patient had grade III renal toxicity, and 3 patients grade II alopecia.
CONCLUSIONS: The above-mentioned treatment has low toxicity, is easy to administer and offers promising results in this group of patients. Copyright 2000 S. Karger AG, Basel