[Gemcitabine and cisplatin (GC) or gemcitabine and carboplatin (GCarbo) in patients with metastatic urothelial cancer].

ABSTRACT

Twenty-four patients with metastatic urothelial carcinoma of bladder (11) and upper urinary tract (13) received gemcitabine 1,000 mg/m2 on days 1, 8, and 15, and cisplatin 70 mg/m2 (GC) or carboplatin area under the serum concentration-time curve (AUC) 5 (GCarbo) on day 2, every 28 days. One to 13 chemotherapy cycles (median number, 4) per patient were administered. Three patients (12.5%) achieved a complete response (CR) and 9 (37.5%) a partial response (PR). Six patients (25%) experienced no change (NC) and six patients (25%) progressive disease (PD). The overall response rate (CR＋PR) of GC (57.9%) was greater than that of GCarbo (20%), but the difference was not statistically significant (p＝0.13). At a median follow-up of 14.7 months, the median time to progression was 4.6 months (range, 0.9-34.7), and the median overall survival 12.3 months (range, 2.1-46.4). Grade 3 and 4 leukocytopenia occurred in 15 patients (53.6%) and grade 3 and 4 thrombocytopenia in 16 (57.1%). Gemcitabine could be administrated on both day 8 and day 15 only in 43 (34.7%) of the total 114 courses because of hematological toxicity. Gemcitabine chemotherapy combined with cisplatin or carboplatin is effective in the management of metastatic urothelial cancer. High hematological toxicity was observed and caused high omission rates of gemcitabine on day 8 and/or day 15.