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
- PMID: 31135850
- PMCID: PMC6547120
- 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
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.
Conflict of interest statement
Figures
Comment in
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Effect of laparoscopic vs. open distal gastrectomy on 3-year disease free survival in patients with locally advanced gastric cancer: commentary on the class-01 randomized clinical trial.Transl Gastroenterol Hepatol. 2019 Nov 26;4:78. doi: 10.21037/tgh.2019.09.14. eCollection 2019. Transl Gastroenterol Hepatol. 2019. PMID: 31872142 Free PMC article. No abstract available.
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Less may be more: shifting paradigm toward minimally invasive gastrectomy for locally advanced gastric cancer.Transl Gastroenterol Hepatol. 2019 Nov 26;4:79. doi: 10.21037/tgh.2019.09.12. eCollection 2019. Transl Gastroenterol Hepatol. 2019. PMID: 31872143 Free PMC article. No abstract available.
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[Should advanced gastric cancer only be operated on laparoscopically in the future?].Strahlenther Onkol. 2021 Apr;197(4):358-360. doi: 10.1007/s00066-021-01746-9. Epub 2021 Mar 9. Strahlenther Onkol. 2021. PMID: 33687484 German. No abstract available.
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