机构：[1]Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China[2]Department of General Surgery, Guangdong Provincial Key Laboratory of Precision and Minimally Invasive Medicine for GI Cancers, Nanfang Hospital, Southern Medical University, Guangzhou, China[3]Department of General Surgery, Zhongshan Hospital, Fudan University, Shanghai, China[4]Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Gastrointestinal Cancer Center Unit 4, Peking University Cancer Hospital, Beijing, China[5]Department of Gastrointestinal Surgery, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China[6]Department of Gastrointestinal Surgery and Laboratory of Gastric Cancer, State Key Laboratory of Biotherapy, West China Hospital, Sichuan University, Chengdu, China四川大学华西医院[7]Department of Gastrointestinal Surgery, the Cancer Hospital of Harbin Medical University, Harbin, China[8]Department of Gastrointestinal Surgery, the First Hospital, Jilin University, Changchun, China[9]Department of Gastrointestinal Surgery, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China华中科技大学同济医学院附属协和医院[10]Department of General Surgery, Tangdu Hospital, Fourth Military Medical University, Xi’an, China[11]Department of Gastrointestinal Surgery, the Third Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China中山大学附属第三医院[12]Department of Gastrointestinal Oncological Surgery, Fujian Provincial Cancer Hospital, Fujian Medical University Teaching Hospital, Fuzhou, China[13]Department of Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China[14]Department of General Surgery, General Hospital of PLA, Beijing, China[15]Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Ward I of the Gastrointestinal Cancer Center, Peking University Cancer Hospital and Institute, Beijing, China[16]Clinical Research Center, Nanfang Hospital, Southern Medical University, Guangzhou, China[17]Department of Biostatistics, School of Public Health, Southern Medical University, Guangzhou, China
It is not clear whether laparoscopic and open distal gastrectomy produce similar outcomes among patients with locally advanced gastric cancer. Data from a multicenter, randomized clinical trial (Chinese Laparoscopic Gastrointestinal Surgical Study [CLASS]-01) showed that laparoscopic distal gastrectomy did not result in inferior disease-free survival at 3 years compared with open distal gastrectomy.To report 5-year overall survival data from the CLASS-01 trial of laparoscopic vs open distal gastrectomy among patients with locally advanced gastric cancer.This was a noninferiority, open-label, randomized clinical trial conducted at 14 centers in China. A total of 1056 eligible patients with clinical stage T2, T3, or T4a gastric cancer without bulky nodes or distant metastases were enrolled from September 12, 2012, to December 3, 2014. Final follow-up was on December 31, 2019.Participants were randomized in a 1:1 ratio after stratification by site, age, cancer stage, and histologic features to undergo either laparoscopic distal gastrectomy (n = 528) or open distal gastrectomy (n = 528) with D2 lymphadenectomy.The 5-year overall survival rates were updated to compare laparoscopic distal gastrectomy with open distal gastrectomy. All analyses were performed on an intention-to-treat basis. In addition, per-protocol and as-treated analyses were performed for overall survival.Data from 1039 patients (726 men [69.9%]; mean [SD] age, 56.2 [10.7] years) who received curative therapy were analyzed. At 5 years, the overall survival rates were 72.6% in the laparoscopic distal gastrectomy group and 76.3% in the open distal gastrectomy group (log-rank P = .19; hazard ratio, 1.17; 95% CI, 0.93-1.48; P = .19). After comparison for competing risk events, gastric cancer-related deaths (hazard ratio, 1.14; 95% CI, 0.87-1.49; P = .34) and deaths from other causes (hazard ratio, 1.23; 95% CI, 0.74-2.05; P = .42) did not differ significantly between groups. Overall rates of survival did not differ significantly between groups with each tumor stage.This study found that laparoscopic distal gastrectomy with D2 lymphadenectomy performed by experienced surgeons in high-volume specialized institutions resulted in similar 5-year overall survival compared with open distal gastrectomy among patients with locally advanced gastric cancer.ClinicalTrials.gov Identifier: NCT01609309.
基金：
Funding was provided by
Guangdong Provincial Key Laboratory of Precision
Medicine for Gastrointestinal Cancer (grant
2020B121201004), Guangdong Provincial Major
Talents Project (grant 2019JC05Y361), National
Natural Science Foundation of China (grant
81872013), the National Project of Improvement of
Complex Diseases Diagnosis and Treatment from
National Development and Reform Commission,
the Key Clinical Specialty Discipline Construction
Program from the National Health and Family
Planning Commission of China, and the Program of
Global Medical Affairs Department of Johnson &
Johnson Medical Ltd (grant IIS2012-100236).
第一作者机构：[1]Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China
共同第一作者：
通讯作者：
通讯机构：[2]Department of General Surgery, Guangdong Provincial Key Laboratory of Precision and Minimally Invasive Medicine for GI Cancers, Nanfang Hospital, Southern Medical University, Guangzhou, China[*1]Department of General Surgery, Guangdong Provincial Key Laboratory of Precision and Minimally Invasive Medicine for GI Cancers, Nanfang Hospital, Southern Medical University, 1838 N Guangzhou Ave, Guangzhou 510-515, China
推荐引用方式(GB/T 7714)：
Changming Huang,Hao Liu,Yanfeng Hu,et al.Laparoscopic vs Open Distal Gastrectomy for Locally Advanced Gastric Cancer: Five-Year Outcomes From the CLASS-01 Randomized Clinical Trial.[J].JAMA SURGERY.2022,157(1):9-17.doi:10.1001/jamasurg.2021.5104.
APA：
Changming Huang,Hao Liu,Yanfeng Hu,Yihong Sun,Xiangqian Su...&Guoxin Li.(2022).Laparoscopic vs Open Distal Gastrectomy for Locally Advanced Gastric Cancer: Five-Year Outcomes From the CLASS-01 Randomized Clinical Trial..JAMA SURGERY,157,(1)
MLA：
Changming Huang,et al."Laparoscopic vs Open Distal Gastrectomy for Locally Advanced Gastric Cancer: Five-Year Outcomes From the CLASS-01 Randomized Clinical Trial.".JAMA SURGERY 157..1(2022):9-17
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