Anzeige
Erschienen in:
01.05.2010 | Original Article
Multicenter, phase II study of gemcitabine and S-1 combination chemotherapy in patients with advanced biliary tract cancer
Erschienen in: Cancer Chemotherapy and Pharmacology | Ausgabe 6/2010
Einloggen, um Zugang zu erhaltenAbstract
Purpose
To evaluate the efficacy and safety of gemcitabine and S-1 combination chemotherapy in patients with advanced biliary tract cancer.
Methods
Patients with a measurable lesion and no previous history of chemotherapy or radiotherapy were enrolled. Gemcitabine was administered intravenously at a dose of 1,000 mg/m2 over 30 min on day 1 and 15, repeated every 4 weeks. S-1 was administered orally at a dose of 40 mg/m2 b.i.d. on days 1–14. Tumor response was assessed every two cycles using Response Evaluation Criteria in Solid Tumors criteria.
Results
As much as 35 patients were enrolled between December 2006 and July 2008; 14 patients (40%) with gallbladder cancer and 14 (40%) with intrahepatic cholangiocarcinoma were included and 7 patients (20%) had received previous surgical resection. The overall response rate was 34.3% and the overall disease control rate was 82.9%. The median overall survival time was 11.6 months (95% CI, 7.3–15.6 months), and the median time to progression was 5.9 months (95% CI, 4.0–7.7 months). The grade 3/4 toxicities were leucopenia (23%), neutropenia (34%), anemia (20%), thrombocytopenia (6%) and anorexia (3%).
Conclusions
Gemcitabine and S-1 combination chemotherapy has promising efficacy and good tolerability in patients with advanced biliary tract cancer.