KEYNOTE-522
Pembrolizumab + Chemotherapy in Early Triple-Negative Breast Cancer
Paziente / Popolazione Intervento / Esposizione Confronto Esito
In 1,174 patients with stage II–III triple-negative breast cancer, neoadjuvant pembrolizumab + platinum/taxane → AC, then adjuvant pembrolizumab improved pathologic complete response and event-free survival compared with placebo + chemotherapy.
N
1174
Disegno
Double-blind RCT
Esito
pCR and EFS (co-primary)
Rilevanza
2
RisultatopCR 64.8% vs 51.2%. 5-yr EFS 81.3% vs 72.3% (HR 0.63). 5-yr OS HR 0.66.
Schmid P, et al. N Engl J Med. 2020;382(9):810-821; Schmid P, et al. N Engl J Med. 2022;386(6):556-567. 10.1056/NEJMoa1910549
Discussione e critica
Established the first immunotherapy-containing (neo)adjuvant regimen in early TNBC. Long-term immune-related toxicity is a real cost in a curative-intent setting.