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oai:recercat.cat:11351/90992025-09-30T02:08:29Zcom_2072_378070com_2072_378040col_2072_378092

Pembrolizumab With or Without Chemotherapy in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma: Updated Results of the Phase III KEYNOTE-048 Study Burtness, Barbara Soulières, Denis Tahara, Makoto de Castro Junior, Gilberto Braña Garcia, Irene Basté Rotllan, Neus Harrington, Kevin Greil, Richard Institut Català de la Salut [Harrington KJ] The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust, National Institute of Health Research Biomedical Research Centre, London, United Kingdom. [Burtness B] Yale Cancer Center and Yale School of Medicine, New Haven, CT. [Greil R] Salzburg Cancer Research Institute-Center for Clinical Cancer and Immunology Trials, Salzburg, Austria. Paracelsus Medical University Hospital, and Cancer Cluster Salzburg, Salzburg, Austria. [Soulières D] Centre Hospitalier de l’Université de Montréal, Montréal, QC, Canada. [Tahara M] National Cancer Center Hospital East, Kashiwa, Japan. [de Castro G Jr] Instituto do Cancer do Estado de Sao Paulo, Sao Paulo, Brazil. [Brana I, Basté N] Vall d’Hebron Hospital Universitari, Barcelona, Spain. Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain Vall d'Hebron Barcelona Hospital Campus Cap - Càncer - Tractament Coll - Càncer - Tractament Anticossos monoclonals - Ús terapèutic Quimioteràpia combinada DISEASES::Neoplasms::Neoplasms by Site::Head and Neck Neoplasms Other subheadings::Other subheadings::Other subheadings::/drug therapy CHEMICALS AND DRUGS::Amino Acids, Peptides, and Proteins::Proteins::Blood Proteins::Immunoproteins::Immunoglobulins::Antibodies::Antibodies, Monoclonal ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Therapeutics::Therapeutics::Drug Therapy::Antineoplastic Protocols::Therapeutics::Drug Therapy::Antineoplastic Combined Chemotherapy Protocols ENFERMEDADES::neoplasias::neoplasias por localización::neoplasias de cabeza y cuello Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia COMPUESTOS QUÍMICOS Y DROGAS::aminoácidos, péptidos y proteínas::proteínas::proteínas sanguíneas::inmunoproteínas::inmunoglobulinas::anticuerpos::anticuerpos monoclonales TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::terapéutica::terapéutica::farmacoterapia::protocolos antineoplásicos::terapéutica::farmacoterapia::protocolos de quimioterapia antineoplásica combinada Pembrolizumab; Carcinoma de células escamosas de cabeza y cuello Pembrolizumab; Head and neck squamous cell carcinoma Pembrolizumab; Carcinoma de cèl·lules escamoses de cap i coll 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. 2023-03-03T08:11:55Z 2023-03-03T08:11:55Z 2023-02-01 info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion Harrington KJ, Burtness B, Greil R, Soulières D, Tahara M, de Castro G, et al. Pembrolizumab With or Without Chemotherapy in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma: Updated Results of the Phase III KEYNOTE-048 Study. J Clin Oncol. 2023 Feb 1;41(4):790–802. 1527-7755 https://hdl.handle.net/11351/9099 10.1200/JCO.21.02508 36219809 eng Journal of Clinical Oncology;41(4) https://doi.org/10.1200/JCO.21.02508 Attribution-NonCommercial-NoDerivatives 4.0 International http://creativecommons.org/licenses/by-nc-nd/4.0/ info:eu-repo/semantics/openAccess application/pdf American Society of Clinical Oncology Scientia