Effect of S-1 Plus Oxaliplatin Compared With Fluorouracil, Leucovorin Plus Oxaliplatin as Perioperative Chemotherapy for Locally Advanced, Resectable Gastric Cancer

作者：Jiren Yu, Yuan Gao, Li Chen, Dan Wu, Qianyun Shen, Zhicheng Zhao, Weihuai Liu, Hanliang Yang, Qi Zhang, Xinbao Wang, Ping Hu, Zhiqiang Zheng, Xianfa Wang, Hongjun Liu, Zekuan Xu, Zhilong Yan, Yingjie Wu, Mingjuan Jin, Qing Zhang, Xiaosun Liu, Kankai Zhu, Chunhui Shou · 发表于：JAMA Network Open · 年份：2022 · DOI：10.1001/jamanetworkopen.2022.0426 · 被引用次数：33 · 研究领域：Gastric Cancer Management and Outcomes、Gastrointestinal Tumor Research and Treatment、Intraperitoneal and Appendiceal Malignancies

IMPORTANCE: Perioperative chemotherapy is a potential treatment for locally advanced gastric cancer. However, the optimal chemotherapy regimen remains unknown. OBJECTIVE: To investigate the safety and efficacy of S-1 plus oxaliplatin (SOX) vs fluorouracil, leucovorin, and oxaliplatin (FOLFOX) as a perioperative chemotherapy regimen for patients with locally advanced gastric cancer. DESIGN, SETTING, AND PARTICIPANTS: In this phase 3, open-label, multicenter, randomized clinical trial, patients from 12 Chinese hospitals were enrolled between June 2011 and August 2016, with a last follow-up date of September 2019. The primary tumor was evaluated as either invading the serosa or the adjacent structures with or without metastatic lymph nodes, and with no evidence of distant metastases. Data were analyzed from December 2019 to June 2020. INTERVENTIONS: Patients were randomly assigned (1:1) to receive either 6 perioperative (2-4 preoperative and 2-4 postoperative) 3-week cycles of 130 mg/m2 oxaliplatin on day 1 and 80 to 120 mg/d S-1 orally daily for 2 weeks (SOX) or 130 mg/m2 oxaliplatin, 400 mg/m2 fluorouracil, 400 mg/m2 leucovorin, and 2400 mg/m2 fluorouracil as 46-hour infusion on day 1 (FOLFOX). MAIN OUTCOMES AND MEASURES: The primary end point was 3-year overall survival (OS). An absolute noninferiority margin of -8% was chosen. RESULTS: A total of 583 patients were enrolled; 293 were randomized to the SOX group and 290 were randomized to the FOLFOX group. Twelve patients (2.1...