2026-04-14T07:42:33Zhttps://recercat.cat/oai/request

oai:recercat.cat:2445/1958052025-11-20T15:52:17Zcom_2072_1057col_2072_478798col_2072_478917

Pembrolizumab with or without chemotherapy in recurrent or metastatic head and neck squamous cell carcinoma: updated results of the phase III KEYNOTE-048 study Harrington, Kevin J. Burtness, Barbara Greil, Richard Soulières, Denis Tahara, Makoto Castro, Gilberto de Psyrri, Amanda Braña, Irene Basté, Neus Neupane, Prakash Bratland, Åse Fuereder, Thorsten Hughes, Brett G.M. Mesía Nin, Ricard Ngamphaiboon, Nuttapong Rordorf, Tamara Ishak, Wan Zamaniah Wan Lin, Jiaxin Gumuscu, Burak Swaby, Ramona F. Rischin, Danny Quimioteràpia Càncer de cap Càncer de coll Anticossos monoclonals Chemotherapy Head cancer Neck cancer Monoclonal antibodies Purpose: Pembrolizumab and pembrolizumab-chemotherapy demonstrated efficacy in recurrent/metastatic head and neck squamous cell carcinoma in KEYNOTE-048. Post hoc analysis of long-term efficacy and progression-free survival on next-line therapy (PFS2) is presented. Methods: Patients were randomly assigned (1:1:1) to pembrolizumab, pembrolizumab-chemotherapy, or cetuximab-chemotherapy. Efficacy was evaluated in programmed death ligand 1 (PD-L1) combined positive score (CPS) ≥ 20, CPS ≥ 1, and total populations, with no multiplicity or alpha adjustment. Results: The median study follow-up was 45.0 months (interquartile range, 41.0-49.2; n = 882). At data cutoff (February 18, 2020), overall survival improved with pembrolizumab in the PD-L1 CPS ≥ 20 (hazard ratio [HR], 0.61; 95% CI, 0.46 to 0.81) and CPS ≥ 1 populations (HR, 0.74; 95% CI, 0.61 to 0.89) and was noninferior in the total population (HR, 0.81; 95% CI, 0.68 to 0.97). Overall survival improved with pembrolizumab-chemotherapy in the PD-L1 CPS ≥ 20 (HR, 0.62; 95% CI, 0.46 to 0.84), CPS ≥ 1 (HR, 0.64; 95% CI, 0.53 to 0.78), and total (HR, 0.71; 95% CI, 0.59 to 0.85) populations. The objective response rate on second-course pembrolizumab was 27.3% (3 of 11). PFS2 improved with pembrolizumab in the PD-L1 CPS ≥ 20 (HR, 0.64; 95% CI, 0.48 to 0.84) and CPS ≥ 1 (HR, 0.79; 95% CI, 0.66 to 0.95) populations and with pembrolizumab-chemotherapy in the PD-L1 CPS ≥ 20 (HR, 0.64; 95% CI, 0.48 to 0.86), CPS ≥ 1 (HR, 0.66; 95% CI, 0.55 to 0.81), and total (HR, 0.73; 95% CI, 0.61 to 0.88) populations. PFS2 was similar after pembrolizumab and longer after pembrolizumab-chemotherapy on next-line taxanes and shorter after pembrolizumab and similar after pembrolizumab-chemotherapy on next-line nontaxanes. Conclusion: With a 4-year follow-up, first-line pembrolizumab and pembrolizumab-chemotherapy continued to demonstrate survival benefit versus cetuximab-chemotherapy in recurrent/metastatic head and neck squamous cell carcinoma. Patients responded well to subsequent treatment after pembrolizumab-based therapy. 2023-03-22T15:59:46Z 2023-04-11T05:10:31Z 2022-10-11 2023-03-22T15:59:46Z info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion Reproducció del document publicat a: https://doi.org/10.1200/JCO.21.02508 Journal of Clinical Oncology, 2022, vol. 41, num. 4, p. 790-802 https://doi.org/10.1200/JCO.21.02508 (c) American Society of Clinical Oncology, 2022 info:eu-repo/semantics/openAccess American Society of Clinical Oncology Articles publicats en revistes (Ciències Clíniques)