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JAMA. 2019 May 28;321(20):1983-1992. doi: 10.1001/jama.2019.5359.

Effect of Laparoscopic vs Open Distal Gastrectomy on 3-Year Disease-Free Survival in Patients With Locally Advanced Gastric Cancer: The CLASS-01 Randomized Clinical Trial.

Author information

1
Department of General Surgery, Nanfang Hospital, Southern Medical University, Guangzhou, China.
2
Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China.
3
Department of General Surgery, Zhongshan Hospital, Fudan University, Shanghai, China.
4
Key laboratory of Carcinogenesis and Translational Research, Ministry of Education, Gastrointestinal Cancer Center, Peking University Cancer Hospital and Institute, Beijing, China.
5
Department of Gastrointestinal Surgery, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
6
Department of Gastrointestinal Surgery & Laboratory of Gastric Cancer, State Key Laboratory of Biotherapy, West China Hospital, Sichuan University, Chengdu, China.
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.
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.
12
Department of Gastrointestinal Oncological Surgery, Fujian Provincial Cancer 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
Department of Biostatistics, School of Public Health, Southern Medical University, Guangzhou, China.

Abstract

Importance:

Laparoscopic distal gastrectomy is accepted as a more effective approach to conventional open distal gastrectomy for early-stage gastric cancer. However, efficacy for locally advanced gastric cancer remains uncertain.

Objective:

To compare 3-year disease-free survival for patients with locally advanced gastric cancer after laparoscopic distal gastrectomy or open distal gastrectomy.

Design, Setting, and Patients:

The study was a noninferiority, open-label, randomized clinical trial 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 2012 to December 2014. Final follow-up was on December 31, 2017.

Interventions:

Participants were randomized in a 1:1 ratio after stratification by site, age, cancer stage, and histology to undergo either laparoscopic distal gastrectomy (n = 528) or open distal gastrectomy (n = 528) with D2 lymphadenectomy.

Main Outcomes and Measures:

The primary end point was 3-year disease-free survival with a noninferiority margin of -10% to compare laparoscopic distal gastrectomy with open distal gastrectomy. Secondary end points of 3-year overall survival and recurrence patterns were tested for superiority.

Results:

Among 1056 patients, 1039 (98.4%; mean age, 56.2 years; 313 [30.1%] women) had surgery (laparoscopic distal gastrectomy [n=519] vs open distal gastrectomy [n=520]), and 999 (94.6%) completed the study. Three-year disease-free survival rate was 76.5% in the laparoscopic distal gastrectomy group and 77.8% in the open distal gastrectomy group, absolute difference of -1.3% and a 1-sided 97.5% CI of -6.5% to ∞, not crossing the prespecified noninferiority margin. Three-year overall survival rate (laparoscopic distal gastrectomy vs open distal gastrectomy: 83.1% vs 85.2%; adjusted hazard ratio, 1.19; 95% CI, 0.87 to 1.64; P = .28) and cumulative incidence of recurrence over the 3-year period (laparoscopic distal gastrectomy vs open distal gastrectomy: 18.8% vs 16.5%; subhazard ratio, 1.15; 95% CI, 0.86 to 1.54; P = .35) did not significantly differ between laparoscopic distal gastrectomy and open distal gastrectomy groups.

Conclusions and Relevance:

Among patients with a preoperative clinical stage indicating locally advanced gastric cancer, laparoscopic distal gastrectomy, compared with open distal gastrectomy, did not result in inferior disease-free survival at 3 years.

Trial Registration:

ClinicalTrials.gov Identifier: NCT01609309.

PMID:
31135850
PMCID:
PMC6547120
DOI:
10.1001/jama.2019.5359
[Indexed for MEDLINE]
Free PMC Article

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