Evidence from Europe shows that perioperative chemotherapy may be beneficial for the treatment of locally advanced gastric cancer, but reliable and robust data is lacking. To rectify this, the phase 3 RESONANCE trial investigated the efficacy and safety of S-1 plus oxaliplatin (SOX) as a perioperative chemotherapy regimen for gastric cancer. This randomized, open-label trial enrolled patients from 19 medical centers with stage II/III resectable gastric cancer who were centrally randomly assigned to either perioperative chemotherapy (PC) arm or adjuvant chemotherapy (AC) arm. Patients in the PC arm received two to four cycles of SOX followed by surgery and four to six cycles of SOX. Patients in the AC arm received upfront surgery and eight cycles of SOX. 386 patients in each group were enrolled and 756 (382 in PC and 374 in AC) were included in the mITT population. The three-year DFS rate was 61.7% in the PC arm and 53.8% in the AC arm (log-rank p = 0.019). The R0 resection rate in the PC arm was significantly higher than that in the AC arm (94.9% vs. 83.7%, p < 0.0001). There was no difference between two arms in surgical outcomes or postoperative complications. Safety-related data were like the known safety profile. In conclusion, from a clinical perspective, this trial indicated a trend towards higher three-year disease-free survival rate with perioperative SOX in stage II/III resectable gastric cancer with well-tolerated toxicity compared to adjuvant SOX, which might provide a theoretical basis for applying perioperative SOX in advanced gastric cancer patients. (ClinicalTrials.gov NCT01583361)

中文翻译：

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II/III 期可切除胃癌的围手术期与辅助 S-1 加奥沙利铂化疗 (RESONANCE)：一项随机、开放标签 3 期试验

来自欧洲的证据表明，围手术期化疗可能有益于局部进展期胃癌的治疗，但缺乏可靠和稳健的数据。为了纠正这个问题，3 期 RESONANCE 试验研究了 S-1 加奥沙利铂 (SOX) 作为胃癌围手术期化疗方案的有效性和安全性。这项随机、开放标签试验招募了来自 19 个医疗中心的 II/III 期可切除胃癌患者，这些患者被集中随机分配到围手术期化疗 (PC) 组或辅助化疗 (AC) 组。 PC 组的患者接受了 2 到 4 个周期的 SOX，然后接受手术，然后接受 4 到 6 个周期的 SOX。 AC 组的患者接受了前期手术和八个周期的 SOX。每组均纳入 386 名患者，其中 756 名患者（PC 组 382 名，AC 组 374 名）被纳入 mITT 人群。 PC 组的三年 DFS 率为 61.7%，AC 组为 53.8%（对数秩 p = 0.019）。 PC 组的 R0 切除率显着高于 AC 组（94.9% vs. 83.7%，p < 0.0001）。两组的手术结果或术后并发症没有差异。安全相关数据就像已知的安全概况。总之，从临床角度来看，本试验表明，与辅助SOX相比，对于毒性耐受良好的II/III期可切除胃癌，围手术期SOX有更高的三年无病生存率的趋势，这可能提供理论依据围手术期 SOX 在晚期胃癌患者中的应用。 （ClinicalTrials.gov NCT01583361）