演題番号 : O36-4
Backgrounds and aim:
Major hepatectomy may affect postoperative liver function and feasibility of adjuvant chemotherapy. We performed feasibility study of adjuvant chemotherapy (gemcitabine or s-1) after major hepatectomy due to biliary tract cancers (KHBO1003) and compared the effect of each chemotherapy (KHBO1208). These studies were performed as multicenter study and KHBO1208 study was supported by JSCO (Japan Society of Clinical Oncology) Clinical Research Grant Program 2012 and 2013; herein we show the results of these studies.
We determined each recommended dose by the continual reassessment method in KHBO1003 phase I study and compared the feasibility and efficacy of each procedures with 10% alpha error and 20% beta error in KHBO1208 phase II study, and p values of <0.10 were considered to indicate a statistically significant difference.
KHBO1003 phase I study showed the following recommended dose: gemcitabine (1000 mg/m2) every 2 weeks or s-1 (80 mg/m2/day) for 28 days every 6 weeks. Seventy patients were enrolled in KHBO1208 phase II study and thirty-five patients were assigned to each arm. There were no statistically significant differences in the patient characteristics of the two arms. There were no statistically significant differences in the treatment completion rate and relative dose intensity of two arms. The comparison of the two arms revealed that overall survival curve of the s-1 arm were superior to gemcitabine (hazard ratio: 0.477).
We completed Phase I/II study of adjuvant gemcitabine or s-1 therapy after major hepatectomy due to biliary tract cancer in multicenter study and showed the possible superiority of s-1 therapy.