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84 Comparative effectiveness of gemcitabine and paclitaxel versus best supportive care in metastatic urothelial carcinoma who have previously been treated with platinum based chemotherapy
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Comparative effectiveness of gemcitabine and paclitaxel versus best supportive care in metastatic urothelial carcinoma who have previously been treated with platinum based chemotherapy Eur Urol Suppl 2013;12;e84
Kudou S., Zakouji H.Z., Takeda M.T. University of Yamanashi, Dept. of Urology, Chuo Yamanashi, Japan INTRODUCTION & OBJECTIVES: Background Several trials of second-line chemotherapy for metastatic urotherial carcinoma were performed. Several phase䊡trials of gemcitabine and paclitaxel in patients with metastatic urotherial carcinoma for second-line chemotherapy were performed. Purpose Gemcitabine and Paclitaxel(GP) and Best supportive care(BSC) were compared in patients with metastatic urothelial carcinoma who have previously been treated with platinum based chemotherapy MATERIAL & METHODS: Patient Twenty nine patients with metastatic urotherial carcinoma who were resistant to methotrexate,vinblastin,doxorubicin and cisplatin (M-VAC) or gemcitabine and cisplatin (GC) chemotherapy regimen were administered chemotherapy consisting of intravenous gemcitabine 2500mg/m(2)and paclitaxel 150mg/m(2) every 2 weeks.(GP ARM) Twenty three patients with metastatic urotherial carcinoma who were resistant to methotrexate,vinblastin,doxorubicin and cisplatin (M-VAC) or gemcitabine and cisplatin (GC) chemotherapy regimen were administered only BSC.(BSC ARM) Methods Toxicities were evaluated in GP ARM patients. We clarified whether overall survival(OS) is related to second line GP treatment using the Kaplan-Meier method,log-rank test. Multivariate analyses of baseline parameters with respect to OS were performed. RESULTS: Result Toxicities were mild, and no life-threatening complications occurred. The objective of median 130 days survival advantage favouring GP was achieved(70vs200days), statistically significant (p=0.015). Multivariate analyses of baseline parameters with respect to OS showed statistically significant effect of GP(HR:0.4119 95%CI 0.1849-0.9174).
CONCLUSIONS: Conclusion GP therapy is a tolerable and active regimen in metastatic urothelial Carcinoma who have previously been treated with platinum based chemotherapy.
Comparative effectiveness of gemcitabine and paclitaxel versus best supportive care in metastatic urothelial carcinoma who have previously been treated with platinum based chemotherapy Eur Urol Suppl 2013;12;e84
Kudou S., Zakouji H.Z., Takeda M.T. University of Yamanashi, Dept. of Urology, Chuo Yamanashi, Japan INTRODUCTION & OBJECTIVES: Background Several trials of second-line chemotherapy for metastatic urotherial carcinoma were performed. Several phase䊡trials of gemcitabine and paclitaxel in patients with metastatic urotherial carcinoma for second-line chemotherapy were performed. Purpose Gemcitabine and Paclitaxel(GP) and Best supportive care(BSC) were compared in patients with metastatic urothelial carcinoma who have previously been treated with platinum based chemotherapy MATERIAL & METHODS: Patient Twenty nine patients with metastatic urotherial carcinoma who were resistant to methotrexate,vinblastin,doxorubicin and cisplatin (M-VAC) or gemcitabine and cisplatin (GC) chemotherapy regimen were administered chemotherapy consisting of intravenous gemcitabine 2500mg/m(2)and paclitaxel 150mg/m(2) every 2 weeks.(GP ARM) Twenty three patients with metastatic urotherial carcinoma who were resistant to methotrexate,vinblastin,doxorubicin and cisplatin (M-VAC) or gemcitabine and cisplatin (GC) chemotherapy regimen were administered only BSC.(BSC ARM) Methods Toxicities were evaluated in GP ARM patients. We clarified whether overall survival(OS) is related to second line GP treatment using the Kaplan-Meier method,log-rank test. Multivariate analyses of baseline parameters with respect to OS were performed. RESULTS: Result Toxicities were mild, and no life-threatening complications occurred. The objective of median 130 days survival advantage favouring GP was achieved(70vs200days), statistically significant (p=0.015). Multivariate analyses of baseline parameters with respect to OS showed statistically significant effect of GP(HR:0.4119 95%CI 0.1849-0.9174).
CONCLUSIONS: Conclusion GP therapy is a tolerable and active regimen in metastatic urothelial Carcinoma who have previously been treated with platinum based chemotherapy.