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

LOMAC

Patient / Population Intervention / Exposition Vergleich Endpunkt

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

1.023Patienten

Design

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.

Endpunkt

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.

Ergebnis3-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.

Diskussion & Kritik

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.