Pembrolizumab alone or with chemotherapy for recurrent or metastatic head and neck squamous cell carcinoma: Health-related quality-of-life results from KEYNOTE-048
Document Type
Article
Publication Date
5-1-2022
Abstract
Objectives: To assess health-related quality of life (HRQoL) with first-line pembrolizumab, pembrolizumabchemotherapy, 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; pembrolizumabchemotherapy 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 cetuximabchemotherapy: 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
Phase III clinical trial, Chemotherapy head and neck neoplasms, Immunotherapy, Patient reported outcome measures, Pembrolizumab
Publication Title
Oral Oncology
Recommended Citation
Rischin, Danny; Harrington, Kevin J.; Greil, Richard; Soulieres, Denis; Tahara, Makoto; de Castro Jr, Gilberto; Psyrri, Amanda; Brana, Irene; Neupane, Prakash; Bratland, Ase; Fuereder, Thorsten; Hughes, Brett G. M.; Mesia, Ricard; Ngamphaiboon, Nuttapong; Rordorf, Tamara; Ishak, Wan Zamaniah Wan; Hong, Ruey-Long; Mendoza, Rene Gonzalez; Jia, Liyi; Chirovsky, Diana; Norquist, Josephine; Jin, Fan; and Burtness, Barbara, "Pembrolizumab alone or with chemotherapy for recurrent or metastatic head and neck squamous cell carcinoma: Health-related quality-of-life results from KEYNOTE-048" (2022). Research Publications (2021 to 2025). 155.
https://knova.um.edu.my/research_publications_2021_2025/155
Divisions
oncology
Funders
Ananya Roy,Merck,Merck Sharp and Dohme
Volume
128
Publisher
Elsevier
Publisher Location
RADARWEG 29, 1043 NX AMSTERDAM, NETHERLANDS