Pembrolizumab alone or with chemotherapy for recurrent or metastatic head and neck squamous cell carcinoma: Health-related quality-of-life results from KEYNOTE-048.
Date
2022-05-01ICR Author
Author
Rischin, D
Harrington, KJ
Greil, R
Soulières, D
Tahara, M
de Castro, G
Psyrri, A
Braña, I
Neupane, P
Bratland, Å
Fuereder, T
Hughes, BGM
Mesía, R
Ngamphaiboon, N
Rordorf, T
Ishak, WZW
Hong, R-L
Mendoza, RG
Jia, L
Chirovsky, D
Norquist, J
Jin, F
Burtness, B
Type
Journal Article
Metadata
Show full item recordAbstract
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.
Collections
Subject
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
Antibodies, Monoclonal, Humanized
Antineoplastic Combined Chemotherapy Protocols
Cetuximab
Chronic Disease
Head and Neck Neoplasms
Humans
Neoplasm Recurrence, Local
Pain
Quality of Life
Squamous Cell Carcinoma of Head and Neck
Surveys and Questionnaires
Research team
Targeted Therapy
Language
eng
Date accepted
2022-03-08
License start date
2022-05-01
Citation
Oral Oncology, 2022, 128 pp. 105815 -
Publisher
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