Because there was no standard chemotherapy for patients with advanced biliary tract cancer before the ABC-02 trial, we treated them with gemcitabine (GEM) alone. However, recently cisplatin (CDDP)–GEM (GC) became standard first-line chemotherapy. We assessed the benefits of chemotherapy with GC after the failed GEM monotherapy before the ABC-02 era.Method
We retrospectively examined the patients with advanced biliary tract cancer, treated with chemotherapy with GC after the failed GEM monotherapy. Eligible patients had unresectable or recurrent biliary tract cancer, objective tumor progression after the GEM chemotherapy, adequate organ function including renal function and ECOG performance status (PS) 0-1. The treatment consisted of CDDP (25 mg/m2 of body-surface area)–GEM (1000 mg/m2) on days 1 and 8, every 3 weeks.Results
Between December 2010 and October 2011, 14 patients were enrolled to our study. Median age was 63 years. There were 11 males and 3 females. The ratio of intrahepatic bile ducts, extrahepatic bile duct, gall bladder was 6:4:4. The ratio of locally advanced and metastatic disease was 1:13, and the ratio of PS0 and PS1 was 4:10. The objective response rate was 21.4%, and the tumor control rate was 57.1%. The median progression-free survival was 6.2 months (95% confidence intervals, 1.5–13.2 months). The median overall survival was not reached. Grade 3 and 4 toxic events included neutropenia (28.6%), anemia (21.4%) and thrombocytopenia (7.1%).Conclusion
GC can be an optional therapy for unresectable or recurrent biliary tract cancer after the failed GEM monotherapy.