Perioperative versus adjuvant S-1 plus oxaliplatin chemotherapy for stage II/III resectable gastric cancer (RESONANCE): a randomized, open-label, phase 3 trial

作者：Xinxin Wang, Canrong Lu, Bo Wei, Shuo Li, Ziyu Li, Yingwei Xue, Yingjiang Ye, Zhongtao Zhang, Yihong Sun, Liang Han, Kai Li, Linghua Zhu, Zhichao Zheng, Yanbing Zhou, Yulong He, Fei Li, Xin Wang, Pin Liang, Hua Huang, Guoli Li, Xian Shen, Jiafu Ji, Yun Tang, Zekuan Xu, Lin Chen, on behalf of RESONANCE study group · 发表于：Journal of Hematology & Oncology · 年份：2024 · DOI：10.1186/s13045-024-01536-7 · 被引用次数：35 · 研究领域：Gastric Cancer Management and Outcomes、Metastasis and carcinoma case studies、Gastrointestinal Tumor Research and Treatment

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 provi...