CheckMate-577
Adjuvant Nivolumab in Resected Oesophageal/GEJ Cancer
Paziente / Popolazione Intervento / Esposizione Confronto Esito
In 794 patients with resected oesophageal/GEJ cancer and residual pathologic disease after neoadjuvant chemoradiation, adjuvant nivolumab for one year improved disease-free survival compared with placebo.
N
794
Disegno
Double-blind RCT
Esito
Disease-free survival
Rilevanza
3
RisultatoDFS 22.4 vs 11.0 months (HR 0.69). Final OS 51.7 vs 35.3 months (HR 0.85; p=0.1064) — not statistically significant.
Kelly RJ, et al. N Engl J Med. 2021;384(13):1191-1203. 10.1056/NEJMoa2032125
Discussione e critica
DFS-positive but OS-not-significant — a recurrent pattern in adjuvant immunotherapy trials. Counsel patients accordingly.