521 COMPARATIVE EFFECTIVENESS OF GEMCITABINE/PACLITAXEL VERSUS BEST SUPPORTIVE CARE IN PATIENTS WITH METASTATIC UROTHELIAL CARCINOMA WHO ARE RESISTANT TO PREVIOUS PLATINUM-BASED CHEMOTHERAPY

Abstract

INTRODUCTION AND OBJECTIVES: Background: Although little advance in the treatment of metastatic urothelial carcinoma of the bladder has been achieved in the recent years, several phase–trials of gemcitabine and paclitaxel as 2nd-line chemotherapy in patients with metastatic urotherial carcinoma were performed. PURPOSE: Gemcitabine/Paclitaxel (GP) and Best supportive care (BSC) were compared in patients with metastatic urothelial carcinoma who have previously been treated with platinum based chemotherapy. PATIENT: Fifty-two patients with metastatic urotherial carcinoma who were resistant to methotrexate,vinblastin,doxorubicin and cisplatin(M-VAC) or gemcitabine and cisplatin (GC) chemotherapy regimen were evaluated. GP ARM; 29 nine patients were treated with chemotherapy consisting of intravenous gemcitabine 2,500mg/m2 and paclitaxel 150mg/m2 every 2 weeks. BSC ARM; 23 patients were treated with only BSC. METHODS: Toxicities were evaluated in GP ARM patients. We clarified whether overall survival (OS) is related to 2nd line GP treatment using the Kaplan-Meier method, log-rank test. Multivariate analyses of baseline parameters with respect to OS were performed. RESULTS: Toxicities were mild, and no life-threatening complications occurred. The objective of median 130 days survival advantage favoring GP was achieved (Figure, 70 vs. 200days), with statistical significance (p 0.015). Multivariate analyses of baseline parameters with respect to OS showed statistically significant effect of GP (Table, HR: 0.4119 95%CI 0.1849-0.9174). CONCLUSIONS: GP therapy is a tolerable and active regimen in metastatic urothelial carcinoma who have previously been treated with platinum based chemotherapy.