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

Antibodies, Monoclonal, Humanized Antineoplastic Combined Chemotherapy Protocols / therapeutic use Cetuximab / therapeutic use Chronic Disease Head and Neck Neoplasms / drug therapy Humans Neoplasm Recurrence, Local / drug therapy Pain / drug therapy Quality of Life Squamous Cell Carcinoma of Head and Neck / drug therapy Surveys and Questionnaires

Chemotherapy head and neck neoplasms Immunotherapy Patient reported outcome measures Pembrolizumab Phase III clinical trial Quality of life Squamous cell carcinoma of head and neck

Journal

Oral oncology

ISSN: 1879-0593

Titre abrégé: Oral Oncol

Pays: England

ID NLM: 9709118

Informations de publication

Date de publication:
05 2022

Historique:

received: 10 11 2021

revised: 04 03 2022

accepted: 08 03 2022

pubmed: 6 4 2022

medline: 4 5 2022

entrez: 5 4 2022

Statut: ppublish

Résumé

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). 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. 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. Pembrolizumab monotherapy and pembrolizumab-chemotherapy extended OS while maintaining HRQoL, further supporting first-line use for R/M HNSCC.

Identifiants

DOI: 10.1016/j.oraloncology.2022.105815 PMID: 35381576

pubmed: 35381576

pii: S1368-8375(22)00104-X

doi: 10.1016/j.oraloncology.2022.105815

pii:

doi:

Substances chimiques

Antibodies, Monoclonal, Humanized 0

pembrolizumab DPT0O3T46P

Cetuximab PQX0D8J21J

Banques de données

ClinicalTrials.gov

['NCT02358031']

Types de publication

Clinical Trial, Phase III Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

Pagination

105815