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dc.contributorVall d'Hebron Barcelona Hospital Campus
dc.contributor.authorBurtness, Barbara
dc.contributor.authorRischin, Danny
dc.contributor.authorGreil, Richard
dc.contributor.authorSoulières, Denis
dc.contributor.authorTahara, Makoto
dc.contributor.authorde Castro Junior, Gilberto
dc.contributor.authorBraña Garcia, Irene
dc.contributor.authorBasté Rotllan, Neus
dc.date.accessioned2022-08-11T06:09:03Z
dc.date.available2022-08-11T06:09:03Z
dc.date.issued2022-07-20
dc.identifier.citationBurtness B, Rischin D, Greil R, Soulières D, Tahara M, de Castro G, et al. Pembrolizumab Alone or With Chemotherapy for Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma in KEYNOTE-048: Subgroup Analysis by Programmed Death Ligand-1 Combined Positive Score. J Clin Oncol. 2022 Jul 20;40(21):2321–32.
dc.identifier.issn1527-7755
dc.identifier.urihttp://hdl.handle.net/11351/7984
dc.descriptionChemotherapy; Head and neck squamous cell carcinoma
dc.description.abstractPURPOSE The phase III KEYNOTE-048 (ClinicalTrials.gov identifier: NCT02358031) trial of pembrolizumab in recurrent or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) included planned efficacy analyses in the total population and in participants with programmed death ligand-1 (PD-L1) combined positive score (CPS) ≥ 1 and CPS ≥ 20. To further characterize the predictive value of PD-L1 expression on outcome, we conducted efficacy analyses in the PD-L1 CPS < 1 and CPS 1-19 subgroups in KEYNOTE-048. METHODS Participants with R/M HNSCC and no prior systemic therapy for R/M disease were randomly assigned 1:1:1 to pembrolizumab, pembrolizumab-chemotherapy, or cetuximab-chemotherapy. Post hoc efficacy analyses of the PD-L1 CPS < 1 and CPS 1-19 subgroups were performed. RESULTS Of 882 participants enrolled, 128 had PD-L1 CPS < 1 and 373 had CPS 1-19. For pembrolizumab versus cetuximab-chemotherapy, the median overall survival was 7.9 versus 11.3 months in the PD-L1 CPS < 1 subgroup (hazard ratio [HR], 1.51 [95% CI, 0.96 to 2.37]) and 10.8 versus 10.1 months in the CPS 1-19 subgroup (HR, 0.86 [95% CI, 0.66 to 1.12]). For pembrolizumab-chemotherapy versus cetuximab-chemotherapy, the median overall survival was 11.3 versus 10.7 months in the PD-L1 CPS < 1 subgroup (HR, 1.21 [95% CI, 0.76 to 1.94]) and 12.7 versus 9.9 months in the CPS 1-19 subgroup (HR, 0.71 [95% CI, 0.54 to 0.94]). CONCLUSION Increased efficacy of pembrolizumab or pembrolizumab-chemotherapy was observed with increasing PD-L1 expression. PD-L1 CPS < 1 subgroup analysis was limited by small participant numbers. Results from the PD-L1 CPS 1-19 subgroup support previous findings of treatment benefit with pembrolizumab monotherapy and pembrolizumab-chemotherapy in patients with PD-L1 CPS ≥ 1 tumors. Although PD-L1 expression is informative, exploration of additional predictive biomarkers is needed for low PD-L1–expressing HNSCC.
dc.language.isoeng
dc.publisherAmerican Society of Clinical Oncology
dc.relation.ispartofseriesJournal of Clinical Oncology;40(21)
dc.rightsAttribution-NonCommercial-NoDerivatives 4.0 International
dc.rights.urihttp://creativecommons.org/licenses/by-nc-nd/4.0/
dc.sourceScientia
dc.subjectCap - Càncer - Tractament
dc.subjectColl - Càncer - Tractament
dc.subjectQuimioteràpia combinada
dc.subject.meshSquamous Cell Carcinoma of Head and Neck
dc.subject.mesh/drug therapy
dc.subject.meshAntineoplastic Combined Chemotherapy Protocols
dc.titlePembrolizumab Alone or With Chemotherapy for Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma in KEYNOTE-048: Subgroup Analysis by Programmed Death Ligand-1 Combined Positive Score
dc.typeinfo:eu-repo/semantics/article
dc.identifier.doi10.1200/JCO.21.02198
dc.subject.decscarcinoma de células escamosas de cabeza y cuello
dc.subject.decs/farmacoterapia
dc.subject.decsprotocolos de quimioterapia antineoplásica combinada
dc.relation.publishversionhttps://doi.org/10.1200/JCO.21.02198
dc.type.versioninfo:eu-repo/semantics/publishedVersion
dc.audienceProfessionals
dc.contributor.organismesInstitut Català de la Salut
dc.contributor.authoraffiliation[Burtness B] Yale University School of Medicine and Yale Cancer Center, New Haven, USA. [Rischin D] Peter MacCallum Cancer Centre and the University of Melbourne, Melbourne, Australia. [Greil R] Paracelsus Medical University, Salzburg Cancer Research Institute, and Cancer Cluster Salzburg, Salzburg, Austria. [Soulières D] Centre Hospitalier de l'Université de Montréal, Montreal, Quebec, 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
dc.identifier.pmid35333599
dc.identifier.wos000827762800006
dc.rights.accessrightsinfo:eu-repo/semantics/openAccess


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