Evaluation of the safety and pathological effects of neoadjuvant full-dose gemcitabine combination radiation therapy in patients with biliary tract cancer

This study aimed to evaluate the safety of neoadjuvant gemcitabine combination radiation therapy in the treatment of biliary tract cancer and to investigate the pathological effects of chemoradiation therapy and its impact on survival. Chemoradiation therapy entailed three cycles of full dose of gemcitabine (1000 mg/m(2) at days 1, 8, and 15, every 4 weeks) with 50-60 Gy radiation (2 Gy/day) at the main tumor and the regional and para-aortic lymph nodes. The present study included 25 patients. All of the patients were pathologically diagnosed before treatment. The relative dose intensity of gemcitabine was 84 %. The average dose of radiation was 53.8 Gy. Sixty percent of the patients underwent pancreatoduodenectomy, and 32 % underwent hemi-hepatectomy due to bile duct cancer (n = 24) or gall bladder cancer (n = 1). During neoadjuvant therapy, 21 patients (84 %) suffered from adverse events. The common hematological adverse events were leukopenia (44 %) and thrombocytopenia (32 %). It was necessary to exchange the plastic biliary stent in 11 patients (44 %). An R0 resection was achieved in 96 % of the patients, with pathological lymph node metastasis noted in 16 %. Moderate or marked histological changes were noted in 32 % of the patients. The 3-year overall survival rate after the first treatment was 74.6 %, with a 3.2-year observation period. Neoadjuvant therapy was feasible and is expected to improve survival by controlling regional extension.