Pembrolizumab alone or with chemotherapy for recurrent or metastatic head and neck squamous cell carcinoma: Health-related quality-of-life results from KEYNOTE-048
Issued Date
2022-05-01
Resource Type
ISSN
13688375
eISSN
18790593
Scopus ID
2-s2.0-85127463915
Pubmed ID
35381576
Journal Title
Oral Oncology
Volume
128
Rights Holder(s)
SCOPUS
Bibliographic Citation
Oral Oncology Vol.128 (2022)
Suggested Citation
Rischin D., Harrington K.J., Greil R., Soulières D., Tahara M., de Castro G., Psyrri A., Braña I., Neupane P., Bratland Å., Fuereder T., Hughes B.G.M., Mesía R., Ngamphaiboon N., Rordorf T., Ishak W.Z.W., Hong R.L., Mendoza R.G., Jia L., Chirovsky D., Norquist J., Jin F., Burtness B. Pembrolizumab alone or with chemotherapy for recurrent or metastatic head and neck squamous cell carcinoma: Health-related quality-of-life results from KEYNOTE-048. Oral Oncology Vol.128 (2022). doi:10.1016/j.oraloncology.2022.105815 Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/84449
Title
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 Affiliation
Ramathibodi Hospital
Vall d‘Hebron Institut de Oncologia
Oslo Universitetssykehus
National Taiwan University Hospital
Peter Maccallum Cancer Centre
Universiti Malaya
National and Kapodistrian University of Athens
Royal Brisbane and Women's Hospital
UniversitatsSpital Zurich
Yale School of Medicine
The Royal Marsden NHS Foundation Trust
Paracelsus Medizinische Privatuniversitat
Medizinische Universität Wien
National Cancer Center Hospital East
Centre Hospitalier de L'Universite de Montreal
Universidade de São Paulo
Merck & Co., Inc.
University of Kansas Medical Center
Hospital Duran i Reynals
Centro Estatal de Cancerológia de Chihuahua
Vall d‘Hebron Institut de Oncologia
Oslo Universitetssykehus
National Taiwan University Hospital
Peter Maccallum Cancer Centre
Universiti Malaya
National and Kapodistrian University of Athens
Royal Brisbane and Women's Hospital
UniversitatsSpital Zurich
Yale School of Medicine
The Royal Marsden NHS Foundation Trust
Paracelsus Medizinische Privatuniversitat
Medizinische Universität Wien
National Cancer Center Hospital East
Centre Hospitalier de L'Universite de Montreal
Universidade de São Paulo
Merck & Co., Inc.
University of Kansas Medical Center
Hospital Duran i Reynals
Centro Estatal de Cancerológia de Chihuahua
Other Contributor(s)
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.