Laparoscopic surgery noninferior to open distal gastrectomy for gastric cancer
Disease-free survival (DFS) at 3 years was comparable between patients with locally advanced gastric cancer who underwent laparoscopic distal gastrectomy and open distal gastrectomy, pointing to the noninferiority of the laparoscopic procedure to the open one, according to the CLASS-01* study.
The Chinese Laparoscopic Gastrointestinal Surgery Study group conducted a multicentre, noninferiority trial involving 1,039 patients (mean age 56.2 years, 30.1 percent female) who were treated for locally advanced gastric cancer (stages T2, T3, or T4a) at 14 hospitals in China between September 2012 and December 2017. Participants were randomly assigned to undergo either laparoscopic (n=519) or open distal gastrectomy (n=520) with D2 lymphadenectomy. Patients were followed up until 31 December 2017. [JAMA 2019;321:1983-1992]
At a median follow-up of 38 months, the 3-year DFS rate was comparable between patients who underwent laparoscopic and open distal gastrectomy (76.5 percent vs 77.8 percent, absolute difference, -1.3). The lower bound of the 1-sided 97.5 percent confidence interval [CI] was -6.5, which did not cross the prespecified noninferiority margin of -10.
OS rate at 3 years was not significantly different between patients in the laparoscopic and open distal gastrectomy groups (83.1 percent vs 85.2 percent, hazard ratio [HR], 1.17, 95 percent CI, 0.86–1.59; p=0.33), nor was the cumulative incidence rate of recurrence at 3 years (18.8 percent vs 16.5 percent, HR, 1.15, 95 percent CI, 0.86–1.54; p=0.35).
These findings were consistent with previous multicentre studies which showed similar oncologic outcomes following laparoscopic and open distal gastrectomy in patients with locally advanced gastric cancer, said the researchers. [Ann Surg 2019;269:887-894; J Clin Oncol 2014;32:627-633]
“From a technical point of view, laparoscopic approaches have the benefits over open surgeries through visual magnification, better exposure, and more delicate manoeuvres of organs, vessels, and nerves,” the researchers said.
“This noninferiority of efficacy, along with the superiority of safety over open gastrectomy, suggest that the indication for laparoscopic distal gastrectomy could be extended to include locally advanced gastric cancer,” they said. [Ann Surg 2012;255:446-456]
As this study was based on an entirely Chinese population, the results may be less pertinent to Western settings where proximal gastrectomy is a more common procedure than distal gastrectomy, said the researchers.
*CLASS-01: Multicenter study on laparoscopic distal subtotal gastrectomy for advanced gastric cancer