Division of Surgical Oncology, Department of Surgery, Faculty of Medicine, Tottori University, 36-1 Nishi-cho, Yonago, Tottori, 683-8504, Japan,
Gastric Cancer. 2014;17(3):508-13. doi: 10.1007/s10120-013-0289-z. Epub 2013 Aug 15.
The Adjuvant Chemotherapy Trial of S-1 for Gastric Cancer established oral S-1 administration for 1 year as the standard postoperative adjuvant chemotherapy for gastric cancer in Japan. We conducted a multicenter cooperative prospective study comparing daily and alternate-day S-1 administration as postoperative adjuvant therapy for gastric cancer.
Patients with Stage II or III gastric cancer who underwent curative surgery were randomly assigned to receive standard daily S-1 administration [group A: 80-120 mg/day S-1 depending on body surface area (BSA); days 1-28 every 6 weeks for 1 year] or alternate-day administration (group B: 80-120 mg/day S-1 depending on BSA; alternate days for 15 months). Treatment completion rate was the primary endpoint, and relative dose intensity and safety, overall survival, and relapse-free survival (RFS) were secondary endpoints.
Seventy-three patients were enrolled. The treatment completion rate was 72.2 % in group A and 91.8 % in group B; the relative dose intensity was 67.5 % in group A and 81.2 % in group B; and compliance was better in group B. Digestive system adverse effects were less frequent in group B than in group A. Median follow-up time was 2.8 years; 3-year survival rate was 69.6 % in group A and 87.3 % in group B; and 3-year RFS rate was 76.4 % in group A and 73.1 % in group B.
Our data show improved compliance and fewer adverse effects with alternate-day S-1 administration, which appears to be a more sustainable option for adjuvant chemotherapy for Stage II or III gastric cancer.
S-1 辅助化疗治疗胃癌研究确立了口服 S-1 治疗 1 年作为日本胃癌术后标准辅助化疗。我们进行了一项多中心合作前瞻性研究，比较了每日和隔日 S-1 给药作为胃癌术后辅助治疗。
接受根治性手术的 II 期或 III 期胃癌患者被随机分配接受标准的每日 S-1 给药[组 A：根据体表面积（BSA）给予 80-120mg/天 S-1；每 6 周 1 次，共 1 年]或隔日给药（组 B：根据 BSA 给予 80-120mg/天 S-1；15 个月隔日给药）。治疗完成率为主要终点，相对剂量强度和安全性、总生存期和无复发生存期（RFS）为次要终点。
共纳入 73 例患者。组 A 的治疗完成率为 72.2%，组 B 为 91.8%；组 A 的相对剂量强度为 67.5%，组 B 为 81.2%；组 B 的依从性更好。组 B 的消化系统不良反应发生率低于组 A。中位随访时间为 2.8 年；组 A 的 3 年生存率为 69.6%，组 B 为 87.3%；组 A 的 3 年 RFS 率为 76.4%，组 B 为 73.1%。
我们的数据显示，隔日 S-1 给药具有更高的依从性和更少的不良反应，这似乎是 II 期或 III 期胃癌辅助化疗的更可持续选择。
