Pembrolizumab alone or with chemotherapy for recurrent or metastatic head and neck squamous cell carcinoma: Health-related quality-of-life results from KEYNOTE-048
- Author(s)
- Rischin, D; Harrington, KJ; Greil, R; Soulieres, D; Tahara, M; de Castro, G, Jr; Psyrri, A; Brana, I; Neupane, P; Bratland, A; Fuereder, T; Hughes, BGM; Mesia, R; Ngamphaiboon, N; Rordorf, T; Wan Ishak, WZ; Hong, RL; Gonzalez Mendoza, R; Jia, L; Chirovsky, D; Norquist, J; Jin, F; Burtness, B;
- Journal Title
- Oral Oncology
- Publication Type
- Research article
- 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.
- Keywords
- 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
- Department(s)
- Medical Oncology
- PubMed ID
- 35381576
- Publisher's Version
- https://doi.org/10.1016/j.oraloncology.2022.105815
- Open Access at Publisher's Site
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Creation Date: 2025-03-07 05:57:19
Last Modified: 2025-03-07 06:00:21