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Long-term outcomes of laparoscopic distal gastrectomy for locally advanced gastric cancer:An individual patient data meta-analysis of KLASS-02 and CLASS-01 randomized controlled trials

摘要Objective:Laparoscopic distal gastrectomy(LDG)has potential as a surgical treatment option for locally advanced gastric cancer(LAGC).However,there is uncertainty regarding the generalizability of LDG efficacy across diverse patient populations and treatment settings.This study aimed to assess the outcomes of LDG vs.open distal gastrectomy(ODG)in patients with LAGC despite differences in clinical trial populations and treatment environments.Methods:The KLASS-02 and CLASS-01 trials are multicenter,non-inferiority,open-label,randomized controlled trials for patients with LAGC eligible for distal subtotal gastrectomy in Korea and China,respectively.Some 1,050 patients were enrolled in KLASS-02,and 1,056 patients were enrolled in CLASS-01.Individual patient data(IPD)from KLASS-02 and CLASS-01 were pooled and analyzed.Results:There were 900 patients in the LDG group and 920 in the ODG group.Baseline characteristics were well balanced between groups.The LDG group had better short-term and recovery outcomes than the ODG group,although anastomotic leakage was more frequent.For patients who underwent LDG vs.ODG,5-year overall survival(OS)was 82.7%[95%confidence interval(95%CI),80.2%-85.2%]vs.83.3%(95%CI,80.9%-85.8%)(P=0.706)and 5-year recurrence-free survival(RFS)was 76.9%(95%CI,74.1%-79.7%)vs.77.9%(95%CI,75.2%-80.6%)(P=0.666),respectively,with a median follow-up of 70 months.In the multivariable prognostic IPD meta-analysis,the operative approach was not independently associated with OS[hazard ratio(HR)=1.045,95%CI,0.833-1.311;P=0.706]or RFS(HR=1.044,95%CI,0.859-1.269;P=0.667)for LDG vs.ODG.In the subgroup analysis,LDG demonstrated a significant association with poorer RFS in the pT4 subgroup(HR=1.377,95%CI,1.022-1.760;P=0.034).Conclusions:Despite differences in patient populations,surgical practices,and postoperative treatments between trials,LDG is oncologically safe with the benefit of being minimally invasive for patients with LAGC,except for the pT4 patients.Therefore,LDG could be a good treatment alternative for patients with LAGC;however,caution should be warranted in its application for patients classified as T4.

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作者 Yanfeng Hu [1] Woo Jin Hyung [2] Huilin Huang [1] Changming Huang [3] Han-Kwang Yang [4] Yihong Sun [5] Young-Kyu Park [6] Xiangqian Su [7] Hyuk-Joon Lee [4] Hui Cao [8] Ji Yeong An [9] Jiankun Hu [10] Wook Kim [11] Kuan Wang [12] Hyoung-Il Kim [13] Jian Suo [14] Hyung-Ho Kim [15] Kaixiong Tao [16] Seung Wan Ryu [17] Xianli He [18] Hoon Hur [19] Hongbo Wei [20] Min-Chan Kim [21] Seong-Ho Kong [4] Mingang Ying [22] Gyu Seok Cho [23] Weiguo Hu [24] Jin-Jo Kim [25] Xiaohui Du [26] Do Joong Park [4] Jiang Yu [1] Keun Won Ryu [27] Hao Liu [1] Young Woo Kim [27] Ziyu Li [28] Jong Won Kim [29] Jiafu Ji [7] Joo-Ho Lee [30] Guoxin Li [1] Sang-Uk Han [19] 学术成果认领
作者单位 Department of General Surgery,Guangdong Provincial Key Laboratory of Precision and Minimally Invasive Medicine for GI Cancers,Nanfang Hospital,Southern Medical University,Guangzhou 510515,China [1] Department of Surgery,Yonsei University College of Medicine,Seoul 03722,Republic of Korea;Department of Faculty Surgery No.1,I.M.Sechenov First Moscow State Medical University,Moscow 119435,Russia [2] Department of Gastric Surgery,Fujian Medical University Union Hospital,Fuzhou 350000,China [3] Department of Surgery,Seoul National University Hospital,Seoul 03080,Republic of Korea [4] Department of General Surgery,Zhongshan Hospital,Fudan University,Shanghai 200032,China [5] Department of Surgery,Chonnam National University Hwasun Hospital,Hwasun 58128,Republic of Korea [6] State Key Laboratory of Holistic Integrative Management of Gastrointestinal Cancers,Beijing Key Laboratory of Carcinogenesis and Translational Research,Gastrointestinal Cancer Center,Peking University Cancer Hospital & Institute,Beijing 100142,China [7] Department of Gastrointestinal Surgery,Renji Hospital,Shanghai Jiao Tong University School of Medicine,Shanghai 200025,China [8] Department of Surgery,Samsung Medical Center,Sungkyunkwan University School of Medicine,Seoul 06351,Republic of Korea [9] Department of Gastrointestinal Surgery and Laboratory of Gastric Cancer,State Key Laboratory of Biotherapy,West China Hospital,Sichuan University,Chengdu 610041,China [10] Department of Surgery,Yeouido St.Mary's Hospital,the Catholic University of Korea,Seoul 07345,Republic of Korea [11] Department of Gastrointestinal Surgery,the Cancer Hospital of Harbin Medical University,Harbin 150081,China [12] Department of Surgery,Yonsei University College of Medicine,Seoul 03722,Republic of Korea [13] Department of Gastrointestinal Surgery,the First Hospital,Jilin University,Changchun 130031,China [14] Department of Surgery,Chung-Ang University Gwangmyeong Hospital,Gwangmyeong 14353,Republic of Korea [15] Department of Gastrointestinal Surgery,Union Hospital,Tongji Medical College,Huazhong University of Science and Technology,Wuhan 430030,China [16] Keimyung University Dongsan Medical Centre,Daegu 42601,Republic of Korea [17] Department of General Surgery,Tangdu Hospital,Fourth Military Medical University,Xi'an 710000,China [18] Department of Surgery,Ajou University School of Medicine,Suwon 16499,Republic of Korea [19] Department of Gastrointestinal Surgery,the Third Affiliated Hospital of Sun Yat-Sen University,Guangzhou 510000,China [20] Department of Surgery,Dong-A University Hospital,Korea,Busan 49201,Republic of Korea [21] Department of Gastrointestinal Oncological Surgery,Fujian Provincial Cancer Hospital,Fujian Medical University Teaching Hospital,Fuzhou 350000,China [22] Department of Surgery,Soonchunhyang University Bucheon Hospital,Bucheon 14584,Republic of Korea [23] Department of Surgery,Ruijin Hospital,Shanghai Jiao Tong University School of Medicine,Shanghai 200025,China [24] Department of Surgery,Incheon St.Mary's Hospital,the Catholic University of Korea,Incheon 21431,Republic of Korea [25] Department of General Surgery,General Hospital of PLA,Beijing 100039,China [26] Center for Gastric Cancer,National Cancer Centre,Goyang 10408,Republic of Korea [27] Key Laboratory of Carcinogenesis and Translational Research(Ministry of Education/Beijing),Gastrointestinal Cancer Center,Peking University Cancer Hospital & Institute,Beijing 100142,China [28] Department of Surgery,Chung-Ang University College of Medicine,Seoul 06973,Republic of Korea [29] Department of Surgery,Eulji University School of Medicine,Seoul 01830,Republic of Korea [30]
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DOI 10.21147/j.issn.1000-9604.2025.03.06
发布时间 2025-08-11(万方平台首次上网日期,不代表论文的发表时间)
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中国癌症研究(英文版)

中国癌症研究(英文版)

2025年37卷3期

中插28,365-376,中插29-中插38页

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