dc.contributor.author | Rischin, D | |
dc.contributor.author | Harrington, KJ | |
dc.contributor.author | Greil, R | |
dc.contributor.author | Soulières, D | |
dc.contributor.author | Tahara, M | |
dc.contributor.author | de Castro, G | |
dc.contributor.author | Psyrri, A | |
dc.contributor.author | Braña, I | |
dc.contributor.author | Neupane, P | |
dc.contributor.author | Bratland, Å | |
dc.contributor.author | Fuereder, T | |
dc.contributor.author | Hughes, BGM | |
dc.contributor.author | Mesía, R | |
dc.contributor.author | Ngamphaiboon, N | |
dc.contributor.author | Rordorf, T | |
dc.contributor.author | Ishak, WZW | |
dc.contributor.author | Hong, R-L | |
dc.contributor.author | Mendoza, RG | |
dc.contributor.author | Jia, L | |
dc.contributor.author | Chirovsky, D | |
dc.contributor.author | Norquist, J | |
dc.contributor.author | Jin, F | |
dc.contributor.author | Burtness, B | |
dc.coverage.spatial | England | |
dc.date.accessioned | 2022-07-19T10:18:33Z | |
dc.date.available | 2022-07-19T10:18:33Z | |
dc.date.issued | 2022-05-01 | |
dc.identifier | ARTN 105815 | |
dc.identifier | S1368-8375(22)00104-X | |
dc.identifier.citation | Oral Oncology, 2022, 128 pp. 105815 - | en_US |
dc.identifier.issn | 1368-8375 | |
dc.identifier.uri | https://repository.icr.ac.uk/handle/internal/5241 | |
dc.identifier.eissn | 1879-0593 | |
dc.identifier.eissn | 1879-0593 | |
dc.identifier.doi | 10.1016/j.oraloncology.2022.105815 | |
dc.description.abstract | OBJECTIVES: 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.format | Print-Electronic | |
dc.format.extent | 105815 - | |
dc.language | eng | |
dc.language.iso | eng | en_US |
dc.publisher | ELSEVIER | en_US |
dc.relation.ispartof | Oral Oncology | |
dc.rights.uri | http://creativecommons.org/licenses/by/4.0/ | en_US |
dc.subject | Chemotherapy head and neck neoplasms | |
dc.subject | Immunotherapy | |
dc.subject | Patient reported outcome measures | |
dc.subject | Pembrolizumab | |
dc.subject | Phase III clinical trial | |
dc.subject | Quality of life | |
dc.subject | Squamous cell carcinoma of head and neck | |
dc.subject | Antibodies, Monoclonal, Humanized | |
dc.subject | Antineoplastic Combined Chemotherapy Protocols | |
dc.subject | Cetuximab | |
dc.subject | Chronic Disease | |
dc.subject | Head and Neck Neoplasms | |
dc.subject | Humans | |
dc.subject | Neoplasm Recurrence, Local | |
dc.subject | Pain | |
dc.subject | Quality of Life | |
dc.subject | Squamous Cell Carcinoma of Head and Neck | |
dc.subject | Surveys and Questionnaires | |
dc.title | Pembrolizumab 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.type | Journal Article | |
dcterms.dateAccepted | 2022-03-08 | |
dc.date.updated | 2022-07-19T10:18:06Z | |
rioxxterms.version | VoR | en_US |
rioxxterms.versionofrecord | 10.1016/j.oraloncology.2022.105815 | en_US |
rioxxterms.licenseref.startdate | 2022-05-01 | |
rioxxterms.type | Journal Article/Review | en_US |
pubs.author-url | https://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-status | Published | |
pubs.volume | 128 | |
icr.researchteam | Targeted Therapy | en_US |
dc.contributor.icrauthor | Harrington, Kevin | |
icr.provenance | Deposited by Mr Arek Surman on 2022-07-19. Deposit type is initial. No. of files: 1. Files: 1-s2.0-S136883752200104X-main.pdf | |