Pembrolizumab alone or with chemotherapy for recurrent or metastatic head and neck squamous cell carcinoma: Health-related quality-of-life results from KEYNOTE-048.
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ICR Authors
Authors
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
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
Document Type
Journal Article
Date
2022-05-01
Date Accepted
2022-03-08
Date Available
2022-07-19T10:18:33Z
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.
Citation
Oral Oncology, 2022, 128 pp. 105815 -
Source Title
Oral Oncology
Publisher
ELSEVIER
ISSN
1368-8375
eISSN
1879-0593
1879-0593
1879-0593
Collections
Research Team
Targeted Therapy