To evaluate each arm independently and compare adjuvant gemcitabine
(GEM) and S-1
chemotherapy after major hepatectomy
(hemihepatectomy or trisectionectomy) for biliary tract cancer
Standardized adjuvant therapy is not performed after major hepatectomy
for BTC, and we determined the recommended dose in the former study (KHBO1003).
We 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/m2
) every 2 weeks; or S-1
/d) for 28 days every 6 weeks. Thirty-five patients were assigned to each arm (alpha error, 10%; beta error, 20%).
No 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).
The comparison of the survival of the 2 groups revealed that adjuvant S-1
therapy may be superior to adjuvant GEM therapy after major hepatectomy