• Shogo Kobayashi, Hiroaki Nagano, Akira Tomokuni, Kunihito Gotoh, Daisuke Sakai, Etsuro Hatano, Satoru Seo, Hiroaki Terajima, Yoichiro Uchida, Tetsuo Ajiki, Hironaga Satake, Keiko Kamei, Taiji Tohyama, Tetsuro Hirose, Iwao Ikai, Satoshi Morita, Tatsuya Ioka, and Kansai Hepato-Biliary Oncology (KHBO) Group.
• Department of Surgery, Graduate School of Medicine, Osaka University, Osaka, Japan.
• Ann. Surg. 2019 Aug 1; 270 (2): 230237230-237.

ObjectiveTo evaluate each arm independently and compare adjuvant gemcitabine (GEM) and S-1 chemotherapy after major hepatectomy (hemihepatectomy or trisectionectomy) for biliary tract cancer (BTC).BackgroundStandardized adjuvant therapy is not performed after major hepatectomy for BTC, and we determined the recommended dose in the former study (KHBO1003).MethodsWe performed a multicenter, randomized phase II study. The primary measure was 1-year recurrence-free survival (RFS); the secondary measures were other RFS, overall survival (OS), and others. The following 6-month adjuvant chemotherapy was administered within 12 weeks of R0/1: GEM (1000 mg/m) every 2 weeks; or S-1 (80 mg/m/d) for 28 days every 6 weeks. Thirty-five patients were assigned to each arm (alpha error, 10%; beta error, 20%).ResultsNo patients were excluded for the per-protocol analysis. There were no statistically significant differences in the patient characteristics of the 2 arms. The 1-year RFS and 1-year OS rates of the GEM arm were 51.4% and 80.0%, respectively, whereas those of the S-1 group were 62.9% and 97.1%. The comparison of the 2 arms revealed that 2-year RFS rate, 1 and 2-year OS rates, and OS curve of the S-1 arm were superior to GEM. With regard to OS, the hazard ratio of the S-1 group was 0.477 (90% confidence interval 0.245-0.927).ConclusionThe comparison of the survival of the 2 groups revealed that adjuvant S-1 therapy may be superior to adjuvant GEM therapy after major hepatectomy for BTC.

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