KEYNOTE-048
Pembrolizumab ± Chemotherapy in Recurrent/Metastatic Head and Neck Cancer
Paciente / Población Intervención / Exposición Comparación Desenlace
In 882 patients with untreated recurrent or metastatic squamous-cell head and neck cancer, pembrolizumab or pembrolizumab + platinum + 5-FU improved overall survival compared with cetuximab + platinum + 5-FU (EXTREME).
N
882
Diseño
Open-label RCT, three arms
Desenlace
Overall survival
Relevancia
2
ResultadoPembro vs EXTREME (CPS ≥20): OS 14.9 vs 10.7 months (HR 0.61). Pembro+chemo vs EXTREME (total): OS 13.0 vs 10.7 months (HR 0.77).
Burtness B, et al. Lancet. 2019;394(10212):1915-1928. 10.1016/S0140-6736(19)32591-7
Discusión y crítica
Replaced the EXTREME regimen as first-line standard in R/M HNSCC. PD-L1 CPS testing is required to select monotherapy candidates.