Gemcitabine plus vinorelbine chemotherapy in patients with advanced bladder carcinoma who are medically unsuitable for or who have failed cisplatin-based chemotherapy.

Abstract

To evaluate the efficacy and toxicity of gemcitabine plus vinorelbine chemotherapy in patients with advanced bladder carcinoma who are unsuitable for or who have failed cisplatin-containing chemotherapy. Thirty-one patients with advanced transitional cell carcinoma (TCC) of the bladder were scheduled to receive gemcitabine and vinorelbine chemotherapy. Twenty-one patients had received no prior chemotherapy and their creatinine clearance was below 50 ml/min (group 1), and the remaining 10 patients did not respond to previous cisplatin-containing chemotherapy (group 2). In group 1, objective response rate was 47.6%, including 2 (9.5%) complete and 8 (38.9%) partial responses. In group 2, partial response was observed in 2 (20%) patients. The median survival time for patients in group 1 and 2 were 15 months (range 3-23) and 7 months (range 3-21), respectively. Grades 3 or 4 leukopenia developed in 16.1% of patients. Overall, 12.9% of the patients suffered from grade 3 nonhematologic toxicity. Our preliminary data indicate that the combination of gemcitabine and vinorelbine is active and well tolerated especially in patients with advanced TCC who are unsuitable for cisplatin-based chemotherapy.