Four months of adjuvant XELOX versus six months in stage II–IIIB gastric cancer: The LOMAC randomized trial

LOMAC

Patient / Population Intervention / Exposition Comparaison Critère de jugement

In patients with stage II-IIIB gastric cancer after curative D2 resection, four months of adjuvant XELOX was non-inferior for 3-year disease-free survival compared with six months of adjuvant XELOX.

N

1 023patients

Schéma

Phase 3, open-label, randomised non-inferiority trial in patients with stage II-IIIB gastric adenocarcinoma after curative D2 resection, comparing four months with six months of adjuvant XELOX.

Critère

3-year disease-free survival, with a non-inferiority margin for the hazard ratio of 1.33, analysed in the modified intention-to-treat population.

Résultat3-year DFS 69.2% with four months vs 70.8% with six months (HR for recurrence or death 1.01; 95% CI 0.82-1.25; one-sided P=0.006 for noninferiority) at a median follow-up of 52.8 months. Grade ≥3 adverse events occurred in 8.4% vs 15.0%. Grade ≥3 peripheral sensory neuropathy occurred in 0.4% vs 5.9%. Treatment completion was 83.6% vs 60.4%.

Xu D, Zhang W, Guo J, et al. Presented at ESMO Congress 2026, abstract LBA81, 23 October. Not yet published.

Discussion et critique

The upper bound of the confidence interval for the hazard ratio sits below the prespecified margin of 1.33, and the median follow-up of 52.8 months makes the 3-year DFS estimate reasonably mature. The abstract reports no overall survival, and a margin of 1.33 still allows some loss of efficacy to count as non-inferior. The primary analysis used a modified intention-to-treat population that the abstract does not define, and no per-protocol result is given, although a per-protocol analysis is the more conservative test in a non-inferiority trial. The open-label design may affect how adverse events were reported, and the results apply only to patients who had a D2 resection.