Background: The objective of this study was to evaluate the efficacy and toxicity of combination chemotherapy with gemcitabine and paclitaxel as a second-line regimen in patients with advanced urothelial carcinoma.
Methods: Twenty patients with advanced urothelial carcinoma who were resistant to an M-VAC (methotrexate, vinblastine, doxorubicin, and cisplatin) chemotherapy regimen were administered chemotherapy consisting of intravenous gemcitabine 2500 mg/m(2) and paclitaxel 150 mg/m(2) (GP) every 2 or 3 weeks.
Results: The patients received a median of 7.7 cycles of treatment (range, 2-20 cycles). Six of the 20 patients (30%; 95% confidence interval [CI], 10%-50%) had a major response to treatment (a complete response [CR] in 5% and a partial response [PR] in 25%). Seven patients (35%) had stable disease (SD). The median duration of response was 4.5 months (range, 1-9 months) and the disease control rate (CR + PR + SD) was 65%. The median survival was 11.5 months (range, 2-22 months) and the 1-year survival rate was 35%. The patients tolerated this regimen well, with only grade 3-4 neutropenia being observed in 6 patients (30%), anemia in 3 (15%), and thrombocytopenia in 1 (5%). The response rate to M-VAC in the first-line chemotherapy was significantly associated with the response to GP as the second-line chemotherapy.
Conclusion: The combination of gemcitabine and paclitaxel is active and well tolerated as a second-line treatment in patients with advanced urothelial carcinoma.