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Laparoscopic vs Open Distal Gastrectomy for Locally Advanced Gastric CancerFive-Year Outcomes From the CLASS-01 Randomized Clinical Trial

Educational Objective To identify whether laparoscopic distal gastrectomy (LDG) yields similar 5-year overall survival to open distal gastrectomy (ODG) for patients with locally advanced gastric cancer.
1 Credit CME
Key Points

Question  Does laparoscopic distal gastrectomy yield similar 5-year overall survival to open distal gastrectomy for patients with locally advanced gastric cancer?

Findings  In this randomized clinical trial of 1056 patients with clinically staged, locally advanced gastric cancer, laparoscopic distal gastrectomy resulted in a 5-year overall survival rate of 73% vs 76% for open distal gastrectomy, with no statistically significant difference between the 2 groups.

Meaning  The finding provides further evidence for the safety and efficacy of laparoscopic gastrectomy for patients assessed preoperatively as having locally advanced cancer.

Abstract

Importance  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.

Objective  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.

Design, Setting, and Patients  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.

Interventions  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.

Main Outcomes and Measures  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.

Results  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.

Conclusions and Relevance  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.

Trial Registration  ClinicalTrials.gov Identifier: NCT01609309

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CME Disclosure Statement: Unless noted, all individuals in control of content reported no relevant financial relationships. If applicable, all relevant financial relationships have been mitigated.

Article Information

Accepted for Publication: August 1, 2021.

Published Online: October 20, 2021. doi:10.1001/jamasurg.2021.5104

Corresponding Author: Guoxin Li, MD, PhD, 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 (gzliguoxin@163.com).

Author Contributions: Dr G. Li had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Drs Huang, H. Liu, Y. Hu, Sun, Su, Cao, and J. Hu contributed equally to this work and should be considered co–first authors.

Concept and design: Huang, H. Liu, Y. Hu, Sun, Su, Cao, J. Hu, Suo, Tao, He, Wei, Ying, W. Hu, Du, F. Liu, Z. Li, Zhao, Chen, G. Li.

Acquisition, analysis, or interpretation of data: Huang, H. Liu, Sun, Su, Cao, J. Hu, Wang, Yu, Zheng, Zhao, Zhang, Chen, G. Li.

Drafting of the manuscript: Huang, H. Liu, Wei, W. Hu, Du, Yu, F. Liu, Z. Li, Zhao, G. Li.

Critical revision of the manuscript for important intellectual content: Huang, Y. Hu, Sun, Su, Cao, J. Hu, Wang, Suo, Tao, He, Ying, Zheng, Zhao, Zhang, Chen, G. Li.

Statistical analysis: Huang, H. Liu, J. Hu, Wang, Wei, Yu, Zhang, Chen.

Obtained funding: G. Li.

Administrative, technical, or material support: H. Liu, Y. Hu, Sun, Su, Cao, J. Hu, Wang, Suo, Tao, He, Wei, Ying, W. Hu, Du, Zheng, F. Liu, Z. Li, G. Li.

Supervision: Huang, Y. Hu, Sun, Su, Cao, Wang, G. Li.

Conflict of Interest Disclosures: None reported.

Funding/Support: 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).

Role of the Funder/Sponsor: The funding sources had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

Group Information: The Chinese Laparoscopic Gastrointestinal Surgery Study (CLASS) Group collaborators are listed in Supplement 3.

Data Sharing Statement: See Supplement 4.

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