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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

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收录情况： ◇ SCIE

作者：
Xiaotian Zhang[1] * ; Han Liang[3] * ; Ziyu Li[4] * ; Yingwei Xue[5] * ; Yanong Wang[7] ; Zhiwei Zhou[8,9] ; Jiren Yu[10] ; Zhaode Bu[1] ; Lin Chen[11] ; Yian Du[12] ; Xinbao Wang[13] ; Aiwen Wu[2] ; Guoli Li[14] ; Xiangqian Su[2] ; Gang Xiao[15] ; Ming Cui[16] ; Dan Wu[17] ; Li Chen[17] ; Xiaojiang Wu[16] ; Yanbing Zhou[18] ; Lianhai Zhang[2] ; Chengxue Dang[19] ; Yulong He[20] ; Zhongtao Zhang[21] ; Yihong Sun[22] ; Yong Li[23] ; Huanqiu Chen[24] ; Yuxian Bai[6] ; Yakun Wang[1] ; Peiwu Yu[25] ; Guanbao Zhu[26] ; Jian Suo[27] ; Baoqing Jia[11] ; Leping Li[28] ; Changming Huang[29] ; Fei Li[30] ; Yingjiang Ye[31] ; Huimian Xu[32] ; Xin Wang[33] ; Yannan Yuan[2] ; Jianyu E[35] ; Xiangji Ying[2] ; Chen Yao[34] ; Lin Shen[1] ; Jiafu Ji[2] ;
机构： [1]State Key Laboratory of Holistic Integrative Management of Gastrointestinal Cancers, Beijing Key Laboratory of Carcinogenesis and Translational Research, Department of Gastrointestinal Oncology,Peking University Cancer Hospital & Institute, Beijing, China [2]Gastrointestinal Cancer Center,Peking University Cancer Hospital & Institute, Beijing, China [3]Department of Abdominal Oncology Surgery, Tianjin Medical University Cancer Institute & Hospital, Tianjin, China [4]Key Laboratory of Carcinogenesis and Translational Research, Ministry of Education, Gastrointestinal Cancer Center, Peking University Cancer Hospital & Institute, Beijing, China [5]Department of Gastrointestinal Surgery,Harbin Medical University Cancer Hospital, Harbin, China [6]Department of Gastrointestinal Oncology,Harbin Medical University Cancer Hospital, Harbin, China [7]Department of Stomach Surgery, Fudan University Shanghai Cancer Center, Shanghai, China [8]Department of Gastric Surgery, Sun Yat-sen University Cancer Center, Guangzhou, China [9]State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China [10]Department of Gastrointestinal Surgery, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China [11]Department of General Surgery, Chinese PLA General Hospital, Beijing, China [12]Department of General Surgery, Zhejiang Cancer Hospital, Hangzhou, China [13]Department of Hepatopancreatobiliary Surgery, Zhejiang Cancer Hospital, Hangzhou, China [14]Department of General Surgery, Jinling Hospital, Nanjing, China [15]Department of General Surgery, Beijing Hospital, Beijing, China [16]Beijing Key Laboratory of Carcinogenesis and Translational Research, Gastrointestinal Cancer Center, Peking University Cancer Hospital & Institute, Beijing, China [17]Department of Gastrointestinal Surgery, The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China [18]Department of Gastrointestinal Surgery, The Affiliated Hospital of Qingdao University, Qingdao, China [19]Department of Oncology Surgery, The First Affiliated Hospital of Xi’an Jiaotong University, Xi’an, China [20]Department of Gastrointestinal Surgery, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China [21]Department of General Surgery, Beijing Friendship Hospital, Capital Medical University, Beijing, China [22]Department of General Surgery, Zhongshan Hospital, Fudan University, Shanghai,China [23]Department of General Surgery, The Fourth Hospital of Hebei Medical University, Shijiazhuang, China [24]Department of General Surgery, Jiangsu Cancer Hospital, Nanjing, China [25]Department of General Surgery, The First Hospital Affiliated to Army Medical University, Chongqing, China [26]Department of Gastrointestinal Surgery, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China [27]Department of Gastrointestinal Surgery, The First Hospital of Jilin University, Changchun, China [28]Department of Gastrointestinal Surgery, Shandong Provincial Hospital, Jinan, China [29]Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China [30]Department of General Surgery, Xuanwu Hospital Capital Medical University, Beijing, China [31]Department of General Surgery, Peking University People’s Hospital, Beijing, China [32]Department of Gastrointestinal Oncology Surgery, The First Hospital of China Medical University, Shenyang, China [33]Department of General Surgery,Peking University First Hospital, Beijing, China [34]Peking University Clinical Research Institute,Peking University First Hospital, Beijing, China [35]Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA
出处：
DOI： 10.1016/S1470-2045(24)00676-4
ISSN：

摘要：
The multicentre RESOLVE trial examined the efficacy of perioperative and postoperative S-1 and oxaliplatin (SOX) compared with postoperative capecitabine and oxaliplatin (CapOx) in gastric or gastro-oesophageal junction cancer. Initial analyses did not encompass overall survival owing to the immature data. This paper provides an updated analysis of the survival data from the RESOLVE trial.In this randomised, open-label, phase 3 study, participants aged 18 years or older with cT4a N+ M0 or cT4b Nany M0 gastric or gastro-oesophageal junction adenocarcinoma who were feasible for D2 lymphadenectomy and had a Karnofsky performance score of 70 or higher were enrolled. Participants were randomly assigned in a 1:1:1 ratio via an interactive web response system, stratified by participating centres and Lauren classification, to receive adjuvant CapOx (eight postoperative cycles of intravenous oxaliplatin 130 mg/m2 on day 1 of each 21-day cycle plus oral capecitabine 1000 mg/m2 twice a day on days 1-14, adjuvant SOX (eight postoperative cycles of intravenous oxaliplatin 130 mg/m2 on day 1 of each 21-day cycle plus oral S-1 40-60 mg twice a day on days 1-14), or perioperative SOX (intravenous oxaliplatin 130 mg/m2 on day 1 of each 21-day cycle plus oral S-1 40-60 mg twice a day for three cycles preoperatively and five cycles postoperatively followed by three cycles of S-1 monotherapy. The primary endpoint, assessed in the modified intention-to-treat population, was 3-year disease-free survival to assess the superiority of perioperative-SOX compared with adjuvant-CapOx and the non-inferiority (hazard ratio [HR] non-inferiority margin of 1·33) of adjuvant-SOX compared with adjuvant-CapOx, and has been reported previously. This final report focuses on the secondary endpoint of 5-year overall survival, also assessed in the modified intention-to-treat population. Other secondary endpoints-R0 resection rate and safety-were not updated in this analysis. The study is registered at ClinicalTrials.gov, NCT01534546, and is complete.Between Aug 15, 2012, and Feb 28, 2017, 1094 patients were enrolled and randomly assigned, of whom 1022 participants were included in the modified intention-to-treat population: 345 (259 male, 86 female) in the adjuvant-CapOx group, 340 (238 male, 102 female) in the adjuvant-SOX group, and 337 (271 male, 66 female) in the perioperative-SOX group. As of April 7, 2022, the median duration of follow-up was 62·8 months (IQR 52·0-75·1). The 5-year overall survival rates were 52·1% (95% CI 46·3-57·5) for the adjuvant-CapOx group, 61·0% (55·3-66·2) for the adjuvant-SOX group, and 60·0% (54·2-65·3), for the perioperative-SOX group. Overall survival was significantly prolonged with perioperative-SOX (HR 0·79; 95% CI 0·62-1·00, p=0·049) and adjuvant-SOX (HR 0·77, 0·61-0·98, p=0·033), compared with adjuvant-CapOx.Consistent with the initial analysis of 3-year disease-free survival, the extended 5-year overall survival analysis from the RESOLVE trial confirmed the survival advantage of perioperative-SOX and adjuvant-SOX compared with the standard adjuvant-CapOx regimen. The SOX regimen, given perioperatively or as an adjuvant treatment, emerges as a potential standard treatment modality for locally advanced gastric or gastro-oesophageal junction cancer management in Asian patients.The National Key Research and Development Program of China, the National Natural Science Foundation of China, the Capital's Funds for Health Improvement and Research, the Beijing Natural Science Foundation, National Natural Science Foundation of China, the Beijing Natural Science Foundation, Taiho, Hengrui Pharmaceutical and Sanofi-Aventis.For the Chinese translation of the abstract see Supplementary Materials section.Copyright © 2025 Elsevier Ltd. All rights reserved, including those for text and data mining, AI training, and similar technologies.

基金：
This work was supported by The National Key Research and Development Program of China (Number 2022YFC2505006), the National Natural Science Foundation of China (Number U22A20327), the Capital’s Funds for Health Improvement and Research (Number 2024-1-1021), the Beijing Natural Science Foundation (Number Z20J00105), National Natural Science Foundation of China (Number 82272627), the Beijing Natural Science Foundation (Number L234003).
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中科院(CAS)分区：
出版当年[2025]版：
大类 | 1 区 医学
小类 | 1 区 肿瘤学
最新[2025]版：
大类 | 1 区 医学
小类 | 1 区 肿瘤学
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出版当年[2023]版：
Q1 ONCOLOGY
最新[2023]版：
Q1 ONCOLOGY

影响因子： 最新[2023版] 最新五年平均 出版当年[2023版] 出版当年五年平均 出版前一年[2022版]

第一作者：
第一作者机构： [1]State Key Laboratory of Holistic Integrative Management of Gastrointestinal Cancers, Beijing Key Laboratory of Carcinogenesis and Translational Research, Department of Gastrointestinal Oncology,Peking University Cancer Hospital & Institute, Beijing, China
共同第一作者：
通讯作者：
推荐引用方式(GB/T 7714)：
Xiaotian Zhang,Han Liang,Ziyu Li,et al.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[J].The Lancet. Oncology.2025,26(3):312-319.doi:10.1016/S1470-2045(24)00676-4.
APA：
Xiaotian Zhang,Han Liang,Ziyu Li,Yingwei Xue,Yanong Wang...&Jiafu Ji.(2025).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.The Lancet. Oncology,26,(3)
MLA：
Xiaotian Zhang,et al."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".The Lancet. Oncology 26..3(2025):312-319

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