主要研究结果:
• 主要入组标准:≥18岁,cT4aN+M0/cT4bN任何M0期,可行D2淋巴结清扫术,KPS≥70分的胃癌或GEJ腺癌
• 按1:1:1的比例分为:
• A:辅助CapOx方案(术后8周期,奥沙利铂130 mg/m² IV D1,卡培他滨1000 mg/m² D1-14 PO BID)
• B:术后辅助SOX方案(术后8周期,奥沙利铂130 mg/m² IV D1,S-1 40-60 mg D1-14 PO BID)
• C:围手术期SOX方案(术前3周期,术后5周期,奥沙利铂130 mg/m² IV D1,S-1 40-60 mg D1-14 PO BID,术后继续3周期S-1单药)
• 分层因素:研究中心及Lauren分类
• 主要终点为3年DFS(C组与A组的优效性 & B组与A组的非劣效性[非劣效性边界为1.33]
• 共纳入1094例患者并随机分组,其中1022例患者纳入改良的意向治疗人群:A/B/C=345/340/337
• 中位随访62.8个月,5年OS:A/B/C=52.1/61.0/60.0%,B组(HR=0.77; 95%CI:0.61-0.98; P=0.033)与C组(HR=0.79; 95%CI:0.62-1.00; P=0.049)较A组均显著延长了OS
参考文献:
Zhang X, Liang H, Li Z, Xue Y, Wang Y, Zhou Z, Yu J, Bu Z, Chen L, Du Y, Wang X, Wu A, Li G, Su X, Xiao G, Cui M, Wu D, Chen L, Wu X, Zhou Y, Zhang L, Dang C, He Y, Zhang Z, Sun Y, Li Y, Chen H, Bai Y, Wang Y, Yu P, Zhu G, Suo J, Jia B, Li L, Huang C, Li F, Ye Y, Xu H, Wang X, Yuan Y, E J, Ying X, Yao C, Shen L, Ji J. Perioperative or postoperative adjuvant oxaliplatin with S-1 versus adjuvant oxaliplatin with capecitabine in patients with locally advanced gastric or gastro-oesophageal junction adenocarcinoma undergoing D2 gastrectomy (RESOLVE): final report of a randomised, open-label, phase 3 trial. Lancet Oncol. 2025 Feb 11:S1470-2045(24)00676-4. doi: 10.1016/S1470-2045(24)00676-4. Epub ahead of print. PMID: 39952264.