Gemcitabine and S-1 Combination Chemotherapy in Patients with Advanced Biliary Tract Cancer: A Retrospective Study

BACKGROUND: The aim of this study was to investigate the efficacy and safety of gemcitabine and S-1 combination chemotherapy in patients with advanced biliary tract cancer. PATIENTS AND METHODS: A retrospective study was performed on 15 consecutive patients. Gemcitabine was administered intravenously at 1,000 mg/m(2) on days 8 and 15. Oral S-1 (60 mg/m(2) in 2 divided doses) was given daily for the first 2 weeks, followed by 1 week of rest. This 3-week course of treatment was repeated. The primary endpoint was response rate, and the secondary endpoints were overall survival, progression-free survival, and safety. RESULTS: The overall response rate was 26.7%, and the disease control rate was 73.4%. The overall survival was 12.0 months (95% CI, 9.5–14.5 months), and the progression-free survival was 8.0 months (95% CI, 4.3–11.7 months). Adverse events of grade 3 or 4 occurred in 33.3%, and the major grade 3/4 toxicities were anemia (20.0%), leukopenia (13.3%), and anorexia (13.3%). CONCLUSION: Gemcitabine and S-1 combination chemotherapy is effective and safe in patients with advanced biliary tract cancer.