Objective: To evaluate the efficacy and toxicity of a gemcitabine and paclitaxel regimen for patients with advanced urothelial carcinoma who had previously been treated with methotrexate, vinblastine, doxorubicin and cisplatin chemotherapy, and to determine the prognostic factors for survival in second-line chemotherapy.
Methods: From June 2005 to April 2010, 24 eligible patients who had previously been treated with methotrexate, vinblastine, doxorubicin and cisplatin chemotherapy were enrolled in this study. Patients received paclitaxel 200 mg/m(2) on Day 1 and gemcitabine 1000 mg/m(2) on Days 1, 8 and 15. The gemcitabine and paclitaxel regimen was repeated every 3 weeks. Patients were evaluated every two cycles by imaging study.
Results: Ten of 24 patients (42%) had major response to the gemcitabine and paclitaxel regimen, including 2 patients (8%) who had complete response. Median survival time and median progression-free survival were 12.4 and 6.1 months, respectively. Good performance status and major response to first-line methotrexate, vinblastine, doxorubicin and cisplatin treatment were significant predictors of overall survival and progression-free survival. Grade 3 or 4 neutropenia occurred in 16 patients (67%), but there were no severe infections. There were no treatment-related deaths.
Conclusions: Gemcitabine and paclitaxel chemotherapy had favorable benefit and safety profiles, and the regimen is recommended as a potential second-line chemotherapy for advanced or metastatic urothelial carcinoma previously treated with methotrexate, vinblastine, doxorubicin and cisplatin chemotherapy.