- 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.
- 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.
- 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.
- Korean population.
- Patient crossover.