Stage 1 GC: laparoscopic gastrectomy noninferior to open approach

  • Kim HH & al.
  • JAMA Oncol
  • 7 Feb 2019

  • curated by Jim Kling
  • Univadis Clinical Summaries
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Takeaway

  • Laparoscopic distal gastrectomy (LDG) and open distal gastrectomy (ODG) yield similar 5-year OS and cancer-specific survival (CSS) in patients with stage 1 gastric adenocarcinoma.

Why this matters

  • LDG has better short-term outcomes than ODG, but its oncological safety had not been determined.

Study design

  • Phase 3, open-label, noninferiority trial (KLASS-01) in which 1416 patients with stage I gastric cancer (33.6% women; mean age, 57.3 years) treated by 15 surgeons from 13 institutes were randomly assigned to ODG or LDG.
  • Funding: Ministry of Health & Welfare, Republic of Korea.

Key results

  • After randomization, 63 patients crossed over from ODG to LDG, and 22 patients crossed over from LDG to ODG.
  • Intention-to-treat analysis (n=1255), 5-year survival: LDG, 94.2%; ODG, 93.3%; P=.64.
  • CSS: 4.2% in the LDG group died of gastric cancer compared with 4.1% in the ODG group.
  • 5-year CSS: LDG, 97.1%; ODG, 97.2%; log-rank P=.91.
  • Post hoc analyses showed no significant survival differences between LDG and ODG in patients with advanced tumor, node-positive disease, clinically advanced cancer, and pathologically advanced cancer.

Limitations

  • Korean population.
  • Patient crossover.

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