Pembrolizumab alone or with chemotherapy for recurrent or metastatic head and neck squamous cell carcinoma: health-related quality-of-life results from KEYNOTE-048

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...

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Autores: Rischin, Danny, Harrington, Kevin J., Greil, Richard, Soulières, Denis, Tahara, Makoto, Castro, Gilberto de, Psyrri, Amanda, Braña, Irene, Neupane, Prakash, Bratland, Åse, Fuereder, Thorsten, Hughes, Brett G.M., Mesía Nin, Ricard, Ngamphaiboon, Nuttapong, Rordorf, Tamara, Ishak, Wan Zamaniah Wan, Hong, Ruey-Long, González Mendoza, René, Jia, Liyi, Chirovsky, Diana, Norquist, Josephine, Jin, Fan, Burtness, Barbara
Tipo de recurso: artículo
Estado:Versión aceptada para publicación
Fecha de publicación:2022
País:España
Institución:Universidad de Barcelona
Repositorio:Dipòsit Digital de la UB
OAI Identifier:oai:diposit.ub.edu:2445/195747
Acceso en línea:https://hdl.handle.net/2445/195747
Access Level:acceso abierto
Palabra clave:Anticossos monoclonals
Quimioteràpia
Malalties cròniques
Càncer de coll
Càncer de cap
Monoclonal antibodies
Chemotherapy
Chronic diseases
Neck cancer
Head cancer
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network_acronym_str ES
network_name_str España
repository_id_str
spelling Pembrolizumab alone or with chemotherapy for recurrent or metastatic head and neck squamous cell carcinoma: health-related quality-of-life results from KEYNOTE-048Rischin, DannyHarrington, Kevin J.Greil, RichardSoulières, DenisTahara, MakotoCastro, Gilberto dePsyrri, AmandaBraña, IreneNeupane, PrakashBratland, ÅseFuereder, ThorstenHughes, Brett G.M.Mesía Nin, RicardNgamphaiboon, NuttapongRordorf, TamaraIshak, Wan Zamaniah WanHong, Ruey-LongGonzález Mendoza, RenéJia, LiyiChirovsky, DianaNorquist, JosephineJin, FanBurtness, BarbaraAnticossos monoclonalsQuimioteràpiaMalalties cròniquesCàncer de collCàncer de capMonoclonal antibodiesChemotherapyChronic diseasesNeck cancerHead cancerObjectives: 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.Elsevier Ltd2022info:eu-repo/semantics/articleinfo:eu-repo/semantics/acceptedVersionapplication/pdfhttps://hdl.handle.net/2445/195747Articles publicats en revistes (Ciències Clíniques)reponame:Dipòsit Digital de la UBinstname:Universidad de BarcelonaInglésVersió postprint del document publicat a: https://doi.org/10.1016/j.oraloncology.2022.105815Oral Oncology, 2022, vol. 128https://doi.org/10.1016/j.oraloncology.2022.105815cc-by-nc-nd (c) Elsevier Ltd, 2022https://creativecommons.org/licenses/by-nc-nd/4.0/info:eu-repo/semantics/openAccessoai:diposit.ub.edu:2445/1957472026-05-27T06:46:51Z
dc.title.none.fl_str_mv Pembrolizumab alone or with chemotherapy for recurrent or metastatic head and neck squamous cell carcinoma: health-related quality-of-life results from KEYNOTE-048
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
spellingShingle Pembrolizumab alone or with chemotherapy for recurrent or metastatic head and neck squamous cell carcinoma: health-related quality-of-life results from KEYNOTE-048
Rischin, Danny
Anticossos monoclonals
Quimioteràpia
Malalties cròniques
Càncer de coll
Càncer de cap
Monoclonal antibodies
Chemotherapy
Chronic diseases
Neck cancer
Head cancer
title_short Pembrolizumab alone or with chemotherapy for recurrent or metastatic head and neck squamous cell carcinoma: health-related quality-of-life results from KEYNOTE-048
title_full Pembrolizumab alone or with chemotherapy for recurrent or metastatic head and neck squamous cell carcinoma: health-related quality-of-life results from KEYNOTE-048
title_fullStr Pembrolizumab alone or with chemotherapy for recurrent or metastatic head and neck squamous cell carcinoma: health-related quality-of-life results from KEYNOTE-048
title_full_unstemmed Pembrolizumab alone or with chemotherapy for recurrent or metastatic head and neck squamous cell carcinoma: health-related quality-of-life results from KEYNOTE-048
title_sort Pembrolizumab alone or with chemotherapy for recurrent or metastatic head and neck squamous cell carcinoma: health-related quality-of-life results from KEYNOTE-048
dc.creator.none.fl_str_mv Rischin, Danny
Harrington, Kevin J.
Greil, Richard
Soulières, Denis
Tahara, Makoto
Castro, Gilberto de
Psyrri, Amanda
Braña, Irene
Neupane, Prakash
Bratland, Åse
Fuereder, Thorsten
Hughes, Brett G.M.
Mesía Nin, Ricard
Ngamphaiboon, Nuttapong
Rordorf, Tamara
Ishak, Wan Zamaniah Wan
Hong, Ruey-Long
González Mendoza, René
Jia, Liyi
Chirovsky, Diana
Norquist, Josephine
Jin, Fan
Burtness, Barbara
author Rischin, Danny
author_facet Rischin, Danny
Harrington, Kevin J.
Greil, Richard
Soulières, Denis
Tahara, Makoto
Castro, Gilberto de
Psyrri, Amanda
Braña, Irene
Neupane, Prakash
Bratland, Åse
Fuereder, Thorsten
Hughes, Brett G.M.
Mesía Nin, Ricard
Ngamphaiboon, Nuttapong
Rordorf, Tamara
Ishak, Wan Zamaniah Wan
Hong, Ruey-Long
González Mendoza, René
Jia, Liyi
Chirovsky, Diana
Norquist, Josephine
Jin, Fan
Burtness, Barbara
author_role author
author2 Harrington, Kevin J.
Greil, Richard
Soulières, Denis
Tahara, Makoto
Castro, Gilberto de
Psyrri, Amanda
Braña, Irene
Neupane, Prakash
Bratland, Åse
Fuereder, Thorsten
Hughes, Brett G.M.
Mesía Nin, Ricard
Ngamphaiboon, Nuttapong
Rordorf, Tamara
Ishak, Wan Zamaniah Wan
Hong, Ruey-Long
González Mendoza, René
Jia, Liyi
Chirovsky, Diana
Norquist, Josephine
Jin, Fan
Burtness, Barbara
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv Anticossos monoclonals
Quimioteràpia
Malalties cròniques
Càncer de coll
Càncer de cap
Monoclonal antibodies
Chemotherapy
Chronic diseases
Neck cancer
Head cancer
topic Anticossos monoclonals
Quimioteràpia
Malalties cròniques
Càncer de coll
Càncer de cap
Monoclonal antibodies
Chemotherapy
Chronic diseases
Neck cancer
Head cancer
description 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.
publishDate 2022
dc.date.none.fl_str_mv 2022
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/acceptedVersion
format article
status_str acceptedVersion
dc.identifier.none.fl_str_mv https://hdl.handle.net/2445/195747
url https://hdl.handle.net/2445/195747
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.relation.none.fl_str_mv Versió postprint del document publicat a: https://doi.org/10.1016/j.oraloncology.2022.105815
Oral Oncology, 2022, vol. 128
https://doi.org/10.1016/j.oraloncology.2022.105815
dc.rights.none.fl_str_mv cc-by-nc-nd (c) Elsevier Ltd, 2022
https://creativecommons.org/licenses/by-nc-nd/4.0/
info:eu-repo/semantics/openAccess
rights_invalid_str_mv cc-by-nc-nd (c) Elsevier Ltd, 2022
https://creativecommons.org/licenses/by-nc-nd/4.0/
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv Elsevier Ltd
publisher.none.fl_str_mv Elsevier Ltd
dc.source.none.fl_str_mv Articles publicats en revistes (Ciències Clíniques)
reponame:Dipòsit Digital de la UB
instname:Universidad de Barcelona
instname_str Universidad de Barcelona
reponame_str Dipòsit Digital de la UB
collection Dipòsit Digital de la UB
repository.name.fl_str_mv
repository.mail.fl_str_mv
_version_ 1869418332125396992
score 15,301603

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