A pilot study of concurrent chemoradiotherapy with gemcitabine and cisplatin in patients with locally advanced biliary tract cancer.

Abstract

Combination chemotherapy with gemcitabine and cisplatin is a standard treatment for patients with advanced biliary tract cancer. This study aimed to evaluate the efficacy and safety of gemcitabine- and cisplatin-based concurrent chemoradiotherapy in patients with unresectable biliary tract cancer. Patients with pathologically proven, unresectable, non-metastatic biliary tract cancer were enrolled. Gemcitabine was administered intravenously at a dose of 1000mg/m(2) on days 1, 8, and 15. Cisplatin was administered intravenously at a dose of 70mg/m(2) on day 1. All the patients underwent concurrent radiotherapy with 45Gy in 1.8-Gy daily fractions. After treatment completion, tumor response was evaluated by using computed tomography. Eighteen patients were enrolled between June 2007 and October 2011. Their median age was 61years (range, 38-72years). Eight patients (44.5%) were diagnosed with gallbladder cancer, six (33.3%) with Klatskin's tumor, and four (22.2%) with distal common bile duct cancer. After treatment completion, partial response was achieved in five patients (27.8%) and stable disease in 13 patients (72.2%). The overall response rate was 27.8%, and the disease stabilization rate was 100%. No grade 4 adverse events or treatment-related deaths occurred. The most common grade 3 adverse events were thrombocytopenia (33.3%) and anemia (11.1%). The median progression-free and overall survival times were 6.8months (range, 4.5-19.8months) and 9.6months (5.4-30.4months), respectively. This study shows that gemcitabine- and cisplatin-based concurrent chemoradiotherapy is feasible and tolerable in patients with unresectable and non-metastatic biliary tract cancer.