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dc.contributor.authorRischin, D
dc.contributor.authorHarrington, KJ
dc.contributor.authorGreil, R
dc.contributor.authorSoulières, D
dc.contributor.authorTahara, M
dc.contributor.authorde Castro, G
dc.contributor.authorPsyrri, A
dc.contributor.authorBraña, I
dc.contributor.authorNeupane, P
dc.contributor.authorBratland, Å
dc.contributor.authorFuereder, T
dc.contributor.authorHughes, BGM
dc.contributor.authorMesía, R
dc.contributor.authorNgamphaiboon, N
dc.contributor.authorRordorf, T
dc.contributor.authorIshak, WZW
dc.contributor.authorHong, R-L
dc.contributor.authorMendoza, RG
dc.contributor.authorJia, L
dc.contributor.authorChirovsky, D
dc.contributor.authorNorquist, J
dc.contributor.authorJin, F
dc.contributor.authorBurtness, B
dc.coverage.spatialEngland
dc.date.accessioned2022-07-19T10:18:33Z
dc.date.available2022-07-19T10:18:33Z
dc.date.issued2022-05-01
dc.identifierARTN 105815
dc.identifierS1368-8375(22)00104-X
dc.identifier.citationOral Oncology, 2022, 128 pp. 105815 -en_US
dc.identifier.issn1368-8375
dc.identifier.urihttps://repository.icr.ac.uk/handle/internal/5241
dc.identifier.eissn1879-0593
dc.identifier.eissn1879-0593
dc.identifier.doi10.1016/j.oraloncology.2022.105815
dc.identifier.doi10.1016/j.oraloncology.2022.105815
dc.description.abstractOBJECTIVES: To assess health-related quality of life (HRQoL) with first-line pembrolizumab, pembrolizumab-chemotherapy, or cetuximab-chemotherapy in recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) in the phase 3 KEYNOTE-048 trial (NCT02358031). MATERIALS AND METHODS: HRQoL was measured using the European Organisation for Research and Treatment of Cancer 30-question quality-of-life (EORTC QLQ-C30), the EORTC 35-question quality-of-life head and neck cancer-specific module (EORTC QLQ-H&N35), and the EuroQol 5-dimension 3-level instruments (EQ-5D-3L). Secondary endpoints included mean change from baseline in EORTC QLQ-C30 global health status/quality of life (GHS/QoL) at week 15 and time to deterioration (TTD) in EORTC QLQ-C30 GHS/QoL and EORTC QLQ-H&N35 pain and swallowing. RESULTS: Of 882 enrolled participants, 844 received ≥ 1 dose of study treatment and completed ≥ 1 HRQoL assessment; adherence was ≥ 79% at week 15 across treatment groups. At week 15, EORTC QLQ-C30 GHS/QoL scores remained stable; no clinically meaningful between-group differences were observed (least squares mean difference, pembrolizumab vs cetuximab-chemotherapy, 0.24; 95% CI, -3.34 to 3.82; pembrolizumab-chemotherapy vs cetuximab-chemotherapy, 0.40; 95% CI, -3.46 to 4.26). Median TTD in EORTC QLQ-C30 GHS/QoL and EORTC QLQ-H&N35 pain and swallowing scores was not reached over 51 weeks across groups, showing stable HRQoL. TTD was similar between groups for EORTC QLQ-C30 GHS/QoL (pembrolizumab vs cetuximab-chemotherapy: HR, 1.38; 95% CI, 0.95-2.00; pembrolizumab-chemotherapy vs cetuximab-chemotherapy: HR, 1.37; 95% CI, 0.94-2.00), as was TTD in EORTC QLQ-H&N35 pain and swallowing scores. CONCLUSIONS: Pembrolizumab monotherapy and pembrolizumab-chemotherapy extended OS while maintaining HRQoL, further supporting first-line use for R/M HNSCC.
dc.formatPrint-Electronic
dc.format.extent105815 -
dc.languageeng
dc.language.isoengen_US
dc.publisherELSEVIERen_US
dc.relation.ispartofOral Oncology
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/en_US
dc.subjectChemotherapy head and neck neoplasms
dc.subjectImmunotherapy
dc.subjectPatient reported outcome measures
dc.subjectPembrolizumab
dc.subjectPhase III clinical trial
dc.subjectQuality of life
dc.subjectSquamous cell carcinoma of head and neck
dc.subjectAntibodies, Monoclonal, Humanized
dc.subjectAntineoplastic Combined Chemotherapy Protocols
dc.subjectCetuximab
dc.subjectChronic Disease
dc.subjectHead and Neck Neoplasms
dc.subjectHumans
dc.subjectNeoplasm Recurrence, Local
dc.subjectPain
dc.subjectQuality of Life
dc.subjectSquamous Cell Carcinoma of Head and Neck
dc.subjectSurveys and Questionnaires
dc.titlePembrolizumab alone or with chemotherapy for recurrent or metastatic head and neck squamous cell carcinoma: Health-related quality-of-life results from KEYNOTE-048.en_US
dc.typeJournal Article
dcterms.dateAccepted2022-03-08
dc.date.updated2022-07-19T10:18:06Z
rioxxterms.versionVoRen_US
rioxxterms.versionofrecord10.1016/j.oraloncology.2022.105815en_US
rioxxterms.licenseref.startdate2022-05-01
rioxxterms.typeJournal Article/Reviewen_US
pubs.author-urlhttps://www.ncbi.nlm.nih.gov/pubmed/35381576
pubs.organisational-group/ICR
pubs.organisational-group/ICR/Primary Group
pubs.organisational-group/ICR/Primary Group/ICR Divisions
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Cancer Biology
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Cancer Biology/Targeted Therapy
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Radiotherapy and Imaging
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Radiotherapy and Imaging/Targeted Therapy
pubs.organisational-group/ICR/ImmNet
pubs.publication-statusPublished
pubs.volume128
icr.researchteamTargeted Therapyen_US
dc.contributor.icrauthorHarrington, Kevin
icr.provenanceDeposited by Mr Arek Surman on 2022-07-19. Deposit type is initial. No. of files: 1. Files: 1-s2.0-S136883752200104X-main.pdf


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