Five-Year Outcomes of a Randomized Phase III Trial Comparing Adjuvant Chemotherapy With S-1 Versus Surgery Alone in Stage II or III Gastric Cancer
Five-Year Outcomes of a Randomized Phase III Trial Comparing Adjuvant Chemotherapy With S-1 Versus Surgery Alone in Stage II or III Gastric Cancer
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DOI：
10.1200/jco.2011.36.5908
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发表时间：
2011-11-20
影响因子：
45.3
通讯作者：
Ohashi, Yasuo
中科院分区：
文献类型：
--
作者：
Sasako, Mitsuru;Sakuramoto, Shinichi;Ohashi, Yasuo
研究目的：对S-1胃癌辅助化疗试验的首次中期分析（中位随访3年）证实，口服氟嘧啶衍生物S-1显著改善了总体生存率（主要终点）。因此，在独立数据和安全性监测委员会的建议下开放了结果。我们报告了入组ACTS-GC研究的患者的5年随访数据。患者和方法组织学确诊的II期或III期胃癌并接受胃切除术和D2淋巴结切除术的患者被随机分配在手术后接受S-1或仅接受手术。S-1（80 - 120 mg/天）给药4周，然后停药2周。这个6周的周期重复了1年。主要终点是总生存率，和次要终点是无复发生存和safety.ResultsThe总生存率在5年为71.7%，在S-1组和61.1%的手术组（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%，仅手术组为53.1%（HR，0.653; 95% CI，0.537 - 0.793）。根据主要人口统计学因素，如性别，年龄，疾病阶段，和组织学类型的亚组分析显示，治疗和任何characteristic.ConclusionOn的基础上，5年的随访数据，术后辅助治疗与S-1被证实，以提高总生存率和无复发生存期的II期或III期胃癌患者进行D2胃切除术。
PurposeThe 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 and MethodsPatients 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.ResultsThe 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.ConclusionOn 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.