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39 PagesPosted: 22 Nov 2024
See all articles by Yanfeng Hu
Yanfeng Hu
Southern Medical University - Department of General Surgery
Woo Jin Hyung
Yonsei University
Huilin Huang
Southern Medical University - Guangdong Provincial Key Laboratory of Gastroenterology
Chang-Ming Huang
Fujian Medical University - Department of Gastric Surgery; Fujian Medical University - Key Laboratory of Ministry of Education of Gastrointestinal Cancer; Fujian Medical University - Fujian Key Laboratory of Tumor Microbiology
Han-Kwang Yang
Seoul National University - Gastric Cancer Center
Yihong Sun
Fudan University
Young-Kyu Park
Chonnam National University
Xiangqian Su
Peking University
Hyuk-Joon Lee
Seoul National University - Seoul National University Hospital
Hui Cao
Shanghai Jiao Tong University (SJTU) - Department of Gastrointestinal Surgery
Ji Yeong An
Sungkyunkwan University School of Medicine
Jian-Kun Hu
Sichuan University - Department of Gastrointestinal Surgery and Laboratory of Gastric Cancer
Wook Kim
The Catholic University of Korea
Kuan Wang
Harbin Medical University
Hyoung-Il Kim
Yonsei University
Jian Suo
The First Hospital of Jilin University - Department of Gastrointestinal Surgery
Hyung-Ho Kim
Chung-Ang University
Kaixiong Tao
Huazhong University of Science and Technology
Seung Wan Ryu
Keimyung University Dongsan Medical Center
Xianli He
Department of General Surgery, Tangdu Hospital, Fourth Military Medical University
Hoon Hur
Ajou University
Hongbo Wei
Sun Yat-sen University (SYSU)
Min-Chan Kim
Dong-A University
Seong-Ho Kong
Seoul National University
Mingang Ying
Department of Gastrointestinal Oncological Surgery, Fujian Provincial Cancer Hospital, Fujian Medical University Teaching Hospital
Gyu Seok Cho
Soonchunhyang University
Weiguo Hu
Shanghai Jiao Tong University (SJTU)
Jin-Jo Kim
Catholic University of Korea
Xiao-hui Du
Chinese General Hospital of People’s Liberation Army - Department of General Surgery
Do Joong Park
Seoul National University - Seoul National University Hospital
Jiang Yu
Southern Medical University - Department of General Surgery
Keun Won Ryu
Chinese Academy of Medical Sciences - National Cancer Center
Hao Liu
Southern Medical University - Department of General Surgery & Guangdong Provincial Key Laboratory of Precision Medicine for Gastrointestinal Tumor
Young Woo Kim
Chinese Academy of Medical Sciences - National Cancer Center
Ziyu Li
Peking University
Jong Won Kim
Chung-Ang University
Jiafu Ji
Peking University
Joo-Ho Lee
Eulji University
Guoxin Li
Southern Medical University - Department of General Surgery & Guangdong Provincial Key Laboratory of Precision Medicine for Gastrointestinal Tumor; Guangdong Provincial Engineering Technology Research Center of Minimally Invasive Surgery
Sang-Uk Han
Ajou University School of Medicine
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Abstract
Background: 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 versus 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 from KLASS-02 and CLASS-01 were pooled and analyzed.
Findings: 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 versus ODG, 5-year OS was 82.7% (95% CI=80.2–85.2%) versus 83.3% (95% CI=80.9–85.8%, P=.706) and 5-year RFS was 76.9% (95% CI=74.1–79.7%) versus 77.9% (95% CI=75.2–80.6%, P=.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 (HR=1.045, 95% CI=.833–1.311, P=.706) or RFS (HR=1.044, 95% CI=.859–1.269, P=.667) for LDG versus 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=.034).
Interpretation: 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.
Trial Registration:KLASS-02, NCT01456598; CLASS-01, NCT01609309
Funding:This study was supported by grants from the National R&D Program for Cancer Control, Ministry of Health & Welfare, Republic of Korea (1320270); Ethicon Endo-Surgery; Jeil Pharmaceutical Co., Ltd; 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); National Project of Improvement of Complex Diseases Diagnosis and Treatment, National Development and Reform Commission of China; Key Clinical Specialty Discipline Construction Program, National Health and Family Planning Commission of China; and Program of Global Medical Affairs Department, Johnson & Johnson Medical Ltd (grant IIS2012-100236).
Declaration of Interest:Woo Jin Hyung retains stock in Hutom company, received research grants from Medtronic and GC Pharma, and received consulting fees from SK Hynix (Wuxi). Sang-Uk Han and Guoxin Li received research grants from the Johnson & Johnson Company. All other authors declare no conflicts of interest.
Ethical Approval:This study was approved by the institutional review board of Ajou University Hospital (AJOUIRB-MDB-2020-596).
Keywords: Gastric neoplasm, Advanced gastric cancer, Laparoscopy.
Suggested Citation:Suggested Citation
Hu, Yanfeng and Hyung, Woo Jin and Huang, Huilin and Huang, Chang-Ming and Yang, Han-Kwang and Sun, Yihong and Park, Young-Kyu and Su, Xiangqian and Lee, Hyuk-Joon and Cao, Hui and An, Ji Yeong and Hu, Jian-Kun and Kim, Wook and Wang, Kuan and Kim, Hyoung-Il and Suo, Jian and Kim, Hyung-Ho and Tao, Kaixiong and Ryu, Seung Wan and He, Xianli and Hur, Hoon and Wei, Hongbo and Kim, Min-Chan and Kong, Seong-Ho and Ying, Mingang and Cho, Gyu Seok and Hu, Weiguo and Kim, Jin-Jo and Du, Xiao-hui and Park, Do Joong and Yu, Jiang and Ryu, Keun Won and Liu, Hao and Kim, Young Woo and Li, Ziyu and Kim, Jong Won and Ji, Jiafu and Lee, Joo-Ho and Li, Guoxin and Han, Sang-Uk, Long-Term Outcomes of Laparoscopic Distal Gastrectomy for Locally Advanced Gastric Cancer: An Individual Patient Data Meta-Analysis ofKLASS-02 andCLASS-01 Randomized Controlled Trials. Available at SSRN: https://ssrn.com/abstract=5028557 or http://dx.doi.org/10.2139/ssrn.5028557
Yanfeng Hu
Southern Medical University - Department of General Surgery ( email )
China
Woo Jin Hyung
Yonsei University ( email )
Huilin Huang
Southern Medical University - Guangdong Provincial Key Laboratory of Gastroenterology ( email )
Chang-Ming Huang
Fujian Medical University - Department of Gastric Surgery ( email )
Fuzhou
China
+86-591-83363366 (Phone)
+86-591-83320319 (Fax)
Fujian Medical University - Key Laboratory of Ministry of Education of Gastrointestinal Cancer ( email )
China
Fujian Medical University - Fujian Key Laboratory of Tumor Microbiology ( email )
Fuzhou
China
Han-Kwang Yang
Seoul National University - Gastric Cancer Center ( email )
Kwanak-gu
Seoul, 151-742
Korea, Republic of (South Korea)
Yihong Sun
Fudan University ( email )
Young-Kyu Park
Chonnam National University ( email )
Xiangqian Su
Peking University ( email )
Hyuk-Joon Lee
Seoul National University - Seoul National University Hospital ( email )
101, Daehak-ro, Jongno-gu
Seoul, 03080
Korea, Republic of (South Korea)
Hui Cao
Shanghai Jiao Tong University (SJTU) - Department of Gastrointestinal Surgery ( email )
160 Pujian Road
Shanghai, 200127
China
Ji Yeong An
Sungkyunkwan University School of Medicine ( email )
Korea, Republic of (South Korea)
Jian-Kun Hu
Sichuan University - Department of Gastrointestinal Surgery and Laboratory of Gastric Cancer ( email )
China
Wook Kim
The Catholic University of Korea ( email )
Korea, Republic of (South Korea)
Kuan Wang
Harbin Medical University ( email )
Hyoung-Il Kim
Yonsei University ( email )
Jian Suo
The First Hospital of Jilin University - Department of Gastrointestinal Surgery
3808 Jiefang Rd.
Hongqi Street
Changchun, Jilin
China
Hyung-Ho Kim
Chung-Ang University ( email )
Kaixiong Tao
Huazhong University of Science and Technology ( email )
Seung Wan Ryu
Keimyung University Dongsan Medical Center ( email )
Xianli He
Department of General Surgery, Tangdu Hospital, Fourth Military Medical University ( email )
Hoon Hur
Ajou University ( email )
Hongbo Wei
Sun Yat-sen University (SYSU) ( email )
Min-Chan Kim
Dong-A University ( email )
Seong-Ho Kong
Seoul National University ( email )
Mingang Ying
Department of Gastrointestinal Oncological Surgery, Fujian Provincial Cancer Hospital, Fujian Medical University Teaching Hospital ( email )
Gyu Seok Cho
Soonchunhyang University ( email )
Weiguo Hu
Shanghai Jiao Tong University (SJTU) ( email )
Jin-Jo Kim
Catholic University of Korea ( email )
Xiao-hui Du
Chinese General Hospital of People’s Liberation Army - Department of General Surgery ( email )
China
Do Joong Park
Seoul National University - Seoul National University Hospital ( email )
101, Daehak-ro, Jongno-gu
Seoul, 03080
Korea, Republic of (South Korea)
Jiang Yu
Southern Medical University - Department of General Surgery ( email )
Keun Won Ryu
Chinese Academy of Medical Sciences - National Cancer Center ( email )
Beijing
China
Hao Liu
Southern Medical University - Department of General Surgery & Guangdong Provincial Key Laboratory of Precision Medicine for Gastrointestinal Tumor ( email )
China
Young Woo Kim
Chinese Academy of Medical Sciences - National Cancer Center ( email )
Beijing
China
Ziyu Li
Peking University ( email )
Jong Won Kim
Chung-Ang University ( email )
Jiafu Ji
Peking University ( email )
Joo-Ho Lee
Eulji University ( email )
Guoxin Li
Southern Medical University - Department of General Surgery & Guangdong Provincial Key Laboratory of Precision Medicine for Gastrointestinal Tumor ( email )
China
Guangdong Provincial Engineering Technology Research Center of Minimally Invasive Surgery ( email )
Guangzhou
China
Sang-Uk Han (Contact Author)
Ajou University School of Medicine ( email )
Suwon
Korea, Republic of (South Korea)
