A retrospective study of chemotherapy with cisplatin plus gemcitabine after the failure of gemcitabine monotherapy for biliary tract cancer.

OBJECTIVE: Before the ABC-02 trial, because there was no standard chemotherapy for patients with advanced biliary tract cancer, we treated them with gemcitabine alone. However, recently cisplatin plus gemcitabine became the standard first-line chemotherapy. We assessed the benefits of gemcitabine plus cisplatin chemotherapy after failed gemcitabine monotherapy.

METHODS: We retrospectively examined patients with advanced biliary tract cancer who were treated with gemcitabine plus cisplatin chemotherapy after failed gemcitabine monotherapy. They had adequate organ function, including renal function and Eastern Cooperative Oncology Group performance status 0-1. The treatment consisted of cisplatin (25 mg/m(2) of body surface area) plus gemcitabine (1000 mg/m(2)) on Days 1 and 8 for every 3 weeks.

RESULTS: Between December 2010 and January 2013, 20 patients were treated. The median age was 63 years. There were 15 males and 5 females. The ratio of intrahepatic bile duct, gall bladder and extrahepatic bile duct was 9:6:5. The ratio of locally advanced and metastatic disease was 2:18, and the ratio of PS0 and PS1 was 5:15. The objective response rate was 15.0%, and the tumour control rate was 60.0%. The median progression-free survival was 6.5 months (95% confidence interval, 2.1-6.9 months). The median overall survival was 13.7 months (95% confidence interval, 8.3-19.7 months). Grade 3-4 toxic events included neutropenia (30%), anaemia (20%) and thrombocytopenia (5%).

CONCLUSION: Cisplatin plus gemcitabine could be an optional therapy for unresectable or recurrent biliary tract cancer after failed gemcitabine monotherapy.