A retrospective study of gemcitabine and cisplatin combination therapy as second-line treatment for advanced biliary tract cancer.

Background: To evaluate the treatment outcome of gemcitabine and cisplatin combination therapy as second-line treatment for advanced biliary tract cancer.

Patients And Methods: Patients with advanced biliary tract cancer who were refractory to gemcitabine-based first-line chemotherapy were treated with gemcitabine and cisplatin combination therapy. Gemcitabine (1,000 mg/m(2)) and cisplatin (25 mg/m(2)) were administered intravenously on days 1 and 8, repeated every 3 weeks.

Results: Sixty patients were included. The tumor response and disease control rates were 1.7 and 58.3%, respectively. The median overall survival and time to progression were 6.7 months (95% CI 4.9-8.1) and 3.5 months (95% CI 2.5-5.0), respectively. Grade 3/4 toxicities included leucopenia (20%), neutropenia (25%), anemia (23%), thrombocytopenia (17%), nausea (2%), anorexia (2%), and liver dysfunction (2%).

Conclusions: Gemcitabine and cisplatin combination therapy showed moderate efficacy and safety as second-line treatment for advanced biliary tract cancer that is refractory to gemcitabine-based first-line chemotherapy.