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- Title
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.
- Authors
Yu, Jiang; Huang, Changming; Sun, Yihong; Su, Xiangqian; Cao, Hui; Hu, Jiankun; Wang, Kuan; Suo, Jian; Tao, Kaixiong; He, Xianli; Wei, Hongbo; Ying, Mingang; Hu, Weiguo; Du, Xiaohui; Hu, Yanfeng; Liu, Hao; Zheng, Chaohui; Li, Ping; Xie, Jianwei; Liu, Fenglin
- Abstract
<bold>Importance: </bold>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.<bold>Objective: </bold>To compare 3-year disease-free survival for patients with locally advanced gastric cancer after laparoscopic distal gastrectomy or open distal gastrectomy.<bold>Design, Setting, and Patients: </bold>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.<bold>Interventions: </bold>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.<bold>Main Outcomes and Measures: </bold>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.<bold>Results: </bold>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.<bold>Conclusions and Relevance: </bold>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.<bold>Trial Registration: </bold>ClinicalTrials.gov Identifier: NCT01609309.
- Subjects
CHINA; STOMACH cancer; PROGRESSION-free survival; GASTRECTOMY; PERITONEAL cancer; CLINICAL trials; COMPARATIVE studies; LAPAROSCOPY; RESEARCH methodology; MEDICAL cooperation; PROGNOSIS; RESEARCH; STATISTICAL sampling; STOMACH tumors; TUMOR classification; EVALUATION research; RANDOMIZED controlled trials
- Publication
JAMA: Journal of the American Medical Association, 2019, Vol 321, Issue 20, p1983
- ISSN
0098-7484
- Publication type
journal article
- DOI
10.1001/jama.2019.5359