Safety of Combination Chemotherapy with Cisplatin and Gemcitabine for Unresectable Biliary Tract Cancer

ABSTRACT Background Combination chemotherapy with cisplatin and gemcitabine (CG) has emerged as the standard treatment of advanced or recurrent biliary tract cancer (ARBTC) and has been introduced into the oncology practice in Japan since August 2011. Objective; It is to evaluate the safety profile and compliance of CG regimen for ARBTC. Methods Cisplatin 25 mg/m2 and gemcitabine 1000 mg/m2 were administerd at days 1 and 8, and repeated every 3 weeks. We retrospectively reviewed toxicity and compliance of CG from electronic medical records. Results From November 2011 to January 2012, eight patients [7 males/1 female, median age, 66 years (40–77), and all patients with PS0/1] with ARBTC underwent CG at our hospital. Primary site were intrahepatic in three, extrahepatic bile duct in three, gallbladder in one, and ampula of Vater in one. As for grade 3/4 toxicity, neutropenia and thrombocytopenia were observed in 4 and 4 of the patients, respectively. Platelet transfusion and GCSF was needed in one and one patient, respectively. Febrile neutropenia was observed in one case. Anorexia (three patients) was relatively common. There were no treatment related deaths. Dose delays and reductions due to adverse events were needed in five and four patients, respectively. Conclusions Caution for hematological toxicity and anorexia is needed to the patients undergoing CG for ARBTC.