Hyogo College of Medicine, 1-1 Mukogawa-cho, Nishinomiya, Hyogo, 663-8501, Japan.
J Clin Oncol. 2011 Nov 20;29(33):4387-93. doi: 10.1200/JCO.2011.36.5908. Epub 2011 Oct 17.
The first planned interim analysis (median follow-up, 3 years) of the Adjuvant Chemotherapy Trial of S-1 for Gastric Cancer confirmed that the oral fluoropyrimidine derivative S-1 significantly improved overall survival, the primary end point. The results were therefore opened at the recommendation of an independent data and safety monitoring committee. We report 5-year follow-up data on patients enrolled onto the ACTS-GC study.
Patients with histologically confirmed stage II or III gastric cancer who underwent gastrectomy with D2 lymphadenectomy were randomly assigned to receive S-1 after surgery or surgery only. S-1 (80 to 120 mg per day) was given for 4 weeks, followed by 2 weeks of rest. This 6-week cycle was repeated for 1 year. The primary end point was overall survival, and the secondary end points were relapse-free survival and safety.
The overall survival rate at 5 years was 71.7% in the S-1 group and 61.1% in the surgery-only group (hazard ratio [HR], 0.669; 95% CI, 0.540 to 0.828). The relapse-free survival rate at 5 years was 65.4% in the S-1 group and 53.1% in the surgery-only group (HR, 0.653; 95% CI, 0.537 to 0.793). Subgroup analyses according to principal demographic factors such as sex, age, disease stage, and histologic type showed no interaction between treatment and any characteristic.
On the basis of 5-year follow-up data, postoperative adjuvant therapy with S-1 was confirmed to improve overall survival and relapse-free survival in patients with stage II or III gastric cancer who had undergone D2 gastrectomy.
S-1 辅助化疗治疗胃癌的首次计划中期分析（中位随访 3 年）证实，口服氟嘧啶衍生物 S-1 可显著改善总生存期，这是主要终点。因此，根据独立的数据和安全监测委员会的建议，结果被公开。我们报告了接受 ACTS-GC 研究入组的患者的 5 年随访数据。
接受 D2 淋巴结清扫术的组织学确认的 II 期或 III 期胃癌患者被随机分配接受手术后的 S-1 或仅手术。S-1（每天 80 至 120 毫克）连续给药 4 周，然后休息 2 周。该 6 周周期重复 1 年。主要终点是总生存期，次要终点是无复发生存期和安全性。
S-1 组的 5 年总生存率为 71.7%，而仅手术组为 61.1%（风险比 [HR]，0.669；95%CI，0.540 至 0.828）。S-1 组的 5 年无复发生存率为 65.4%，而仅手术组为 53.1%（HR，0.653；95%CI，0.537 至 0.793）。根据性别、年龄、疾病分期和组织学类型等主要人口统计学因素进行的亚组分析显示，治疗与任何特征之间没有相互作用。
基于 5 年随访数据，D2 胃切除术后，S-1 辅助治疗可改善 II 期或 III 期胃癌患者的总生存期和无复发生存期。
