2026-04-14T05:06:04Zhttps://recercat.cat/oai/requestoai:recercat.cat:2445/1957472025-11-20T15:54:20Zcom_2072_1057col_2072_478798col_2072_478917
urn:hdl:2445/195747
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
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
Anticossos monoclonals
Quimioteràpia
Malalties cròniques
Càncer de coll
Càncer de cap
Monoclonal antibodies
Chemotherapy
Chronic diseases
Neck cancer
Head cancer
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.
2023-03-21T18:11:11Z
2023-03-21T18:11:11Z
2022-05
2023-03-21T18:11:11Z
info:eu-repo/semantics/article
info:eu-repo/semantics/acceptedVersion
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
cc-by-nc-nd (c) Elsevier Ltd, 2022
https://creativecommons.org/licenses/by-nc-nd/4.0/
info:eu-repo/semantics/openAccess
Elsevier Ltd
Articles publicats en revistes (Ciències Clíniques)