• Hiroaki Yanagimoto, Hideyoshi Toyokawa, Daisuke Sakai, Hiroshi Wada, Sohei Satoi, Tomohisa Yamamoto, Hiroaki Nagano, Masanori Toyoda, Tetsuo Ajiki, Hironaga Satake, Akihito Tsuji, Atsushi Miyamoto, Masanori Tsujie, Shigekazu Takemura, Kazuhiro Yanagihara, and Tatsuya Ioka.
• Department of Surgery, Kansai Medical University, 2-5-1 Shin-machi, Hirakata, 573-1010, Japan. yanagimh@hirakata.kmu.ac.jp.
• Cancer Chemother. Pharmacol. 2018 Mar 1; 81 (3): 461-468.

PurposeTo determine the recommended dose (RD) of gemcitabine (GEM) plus S-1 (GS) in curatively resected biliary tract cancer (BTC) patients without major hepatectomy.MethodsA standard 3 + 3 dose-escalation design was used with planned dose levels (mg/m2) of GEM (administered intravenously on days 1 and 8) and S-1 (administered orally twice daily on days 1-14, with a 1-week rest, every 3 weeks for up to 24 weeks) of 1000/80 (Level 2), 1000/65 (Level 1), 800/65 (Level - 1), and 800/50 (Level - 2).ResultsThirty-one patients (17 men and 14 women; median age, 70 years) were enrolled. Level 1 was chosen as the starting dose. Three of seven patients developed dose-limiting toxicities at Level 1 and the dose was de-escalated to Level - 1. Five of 12 patients developed Grade 4 neutropenia at Level - 1 and the dose was de-escalated to Level - 2. One patient developed Grade 4 neutropenia at Level - 2. Another patient was unable to receive the day 8 dose due to Grade 3 neutropenia at Level - 2. Level - 1 was confirmed as the maximum tolerated dose and Level - 2 the RD for this regimen. The 1- and 2-year recurrence-free survival rates were 77.0 and 54.0%, respectively. The recurrence-free survival rate of patients in the GS completion group was significantly higher than that of the GS discontinuation group.ConclusionsLevel - 2 was confirmed as the RD (GEM 800 mg/m2 and S-1 50 mg/m2) for GS adjuvant chemotherapy in curatively resected BTC patients without major hepatectomy.

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