Japanese Journal of Clinical Oncology Advance Access originally published online on February 10, 2009
Japanese Journal of Clinical Oncology 2009 39(4):244-250; doi:10.1093/jjco/hyp003
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© The Author (2009). Published by Oxford University Press. All rights reserved
Combination of Gemcitabine and Paclitaxel as Second-line Chemotherapy for Advanced Urothelial Carcinoma
1 Division of Urology, Chiba Cancer Center, Chiba
2 Department of Urology, Graduate School of Medicine, Chiba University, Chiba, Japan
For reprints and all correspondence: Takeshi Ueda, Division of Urology, Chiba Cancer Center, 666-2, Nitona-cho, Chuo-ku, Chiba 260-8717, Japan. E-mail: urolccc{at}yahoo.co.jp
Received November 23, 2008; accepted January 4, 2009
Objective: The aim of this study was to evaluate the efficacy and toxicities of the gemcitabine and paclitaxel combination regimen as second-line chemotherapy for patients with advanced or metastatic urothelial carcinoma (UC) who have previously been treated with platinum-based chemotherapy for the metastatic disease.
Methods: Thirty-three patients with advanced or metastatic UC who had received platinum-based chemotherapy were treated with an outpatient gemcitabine and paclitaxel combination regimen. A dose of 180 mg/m2 paclitaxel was administered by intravenous (IV) infusion on Day 1, and 1000 mg/m2 gemcitabine was administered by IV on Days 1, 8 and 15.The course was repeated every 28 days. Patients were evaluated after every 2 cycles of therapy using computed tomography.
Results: Of the 33 patients enrolled in this study, 30 could be evaluated to determine treatment efficacy; 10 had an objective response [overall response rate: 33.3%, 95% confidence interval (CI), 19.2–51.2%]. The median overall survival was 11.3 months (95% CI, 7.2–13.6 months). The chemotherapy sensitivity differed with disease site. The response rates of lung and bone metastases were 27% and 14%, and the progressive disease (PD) rates of lung and bone metastases were 13% and 14%, respectively. On the other hand, the response rate of liver metastasis was 14%, and its PD rate was 57%. None of the patients (n = 3) with adrenal metastasis responded to this regimen. Toxicities were mild, and no life-threatening complications occurred.
Conclusions: Gemcitabine and paclitaxel combination therapy is a tolerable and active regimen for patients with advanced UC after failure of platinum-based chemotherapy.
Key Words: gemcitabine • paclitaxel • second-line chemotherapy • advanced urothelial carcinoma