Pembrolizumab alone or with chemotherapy for recurrent or metastatic head and neck squamous cell carcinoma: Health-related quality-of-life results from KEYNOTE-048

Danny Rischin; Kevin J Harrington; Richard Greil; Denis Soulières; Makoto Tahara; Gilberto de Castro Jr; Amanda Psyrri; Irene Braña; Prakash Neupane; Åse Bratland; Thorsten Fuereder; Brett G M Hughes; Ricard Mesía; Nuttapong Ngamphaiboon; Tamara Rordorf; Wan Zamaniah Wan Ishak; Ruey-Long Hong; René Gonzalez Mendoza; Liyi Jia; Diana Chirovsky; Josephine Norquist; Fan Jin; Barbara Burtness

doi:10.1016/j.oraloncology.2022.105815

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 Oncol. 2022 May:128:105815. doi: 10.1016/j.oraloncology.2022.105815. Epub 2022 Apr 2.

Authors

Danny Rischin¹, Kevin J Harrington², Richard Greil³, Denis Soulières⁴, Makoto Tahara⁵, Gilberto de Castro Jr⁶, Amanda Psyrri⁷, Irene Braña⁸, Prakash Neupane⁹, Åse Bratland¹⁰, Thorsten Fuereder¹¹, Brett G M Hughes¹², Ricard Mesía¹³, Nuttapong Ngamphaiboon¹⁴, Tamara Rordorf¹⁵, Wan Zamaniah Wan Ishak¹⁶, Ruey-Long Hong¹⁷, René Gonzalez Mendoza¹⁸, Liyi Jia¹⁹, Diana Chirovsky²⁰, Josephine Norquist²¹, Fan Jin²², Barbara Burtness²³

Affiliations

¹ Medical Oncology, Peter MacCallum Cancer Centre and University of Melbourne, 305 Grattan Street, Melbourne, VIC 3000, Australia. Electronic address: [email protected].
² Radiotherapy and Imaging, The Institute of Cancer Research/The Royal Marsden NHS Foundation Trust, National Institute for Health Research Biomedical Research Centre, 15 Cotswold Road, London SM2 5NG, United Kingdom. Electronic address: [email protected].
³ Hematology and Medical Oncology, Paracelsus Medical University, Salzburg Cancer Research Institute, and Cancer Cluster Salzburg, Hellbrunner Strasse 34, Salzburg 5020, Austria. Electronic address: [email protected].
⁴ Haematology/Oncology, Centre Hospitalier de l'Université de Montréal, 1000 Saint Denis Street, Montreal, QC H2X 0C1, Canada. Electronic address: [email protected].
⁵ Head and Neck Medical Oncology, National Cancer Center Hospital East, 6-5-1 Kashiwanoba, Kashiwa 277-8577, Japan. Electronic address: [email protected].
⁶ Medical Oncology, Instituto do Câncer do Estado de São Paulo, Av. Dr. Arnaldo, 251-Cerqueira César, São Paulo, 01246-000, Brazil. Electronic address: [email protected].
⁷ Medical Oncology, National and Kapodistrian University of Athens, Attikon University Hospital, Athens 157 72, Athens, Greece. Electronic address: [email protected].
⁸ Medical Oncology Department, Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Passeig de la Vall d'Hebron, 119-129, 08035 Barcelona, Spain. Electronic address: [email protected].
⁹ Hematology/Oncology, University of Kansas Medical Center, 3901 Rainbow Boulevard, Kansas City, MO 66160, USA. Electronic address: [email protected].
¹⁰ Head & Neck Oncology, Oslo University Hospital, Bygg 19, Oslo, Norway. Electronic address: [email protected].
¹¹ Medicine I, Medical University of Vienna, Spitalgasse 23, 1090 Vienna, Austria. Electronic address: [email protected].
¹² Clinical Research Unit, Medical Oncology, Royal Brisbane & Women's Hospital and The University of Queensland, Butterfield Street, Ground Floor, Building 34, Herston, Queensland 4029, Australia. Electronic address: [email protected].
¹³ Head and Neck, Catalan Institute of Oncology, L'Hospitalet de Llobregat, Hospital Duran i Reynals, Avinguda de la Gran Via de l'Hospitalet, 199-203, 8908 Barcelona, Spain. Electronic address: [email protected].
¹⁴ Medicine, Ramathibodi Hospital, Mahidol University, 270 Rama 6 Road, Ratchathewi, Bangkok 10400, Thailand. Electronic address: [email protected].
¹⁵ Oncology, University Hospital, Raemistrasse 100, Zurich, Switzerland. Electronic address: [email protected].
¹⁶ Clinical Oncology Unit, Faculty of Medicine, University of Malaya, Jalan Universiti, 50603 Kuala Lumpur, Wilayah Persekutuan, Malaysia. Electronic address: [email protected].
¹⁷ Oncology, National Taiwan University Hospital, No.1, Changde St. Zhongzheng Dist, Taipei 10048, Taiwan. Electronic address: [email protected].
¹⁸ Surgical Oncology, Centro Estatal de Cancerológia de Chihuahua, C. Ejercito Mexicano 3700, 31000 El Bajo, Chihuahua, Mexico. Electronic address: [email protected].
¹⁹ Merck Research Labs, Merck & Co. Inc, 2000 Galloping Hill Road, Kenilworth, NJ 07033, USA. Electronic address: [email protected].
²⁰ Merck Research Labs, Merck & Co. Inc, 2000 Galloping Hill Road, Kenilworth, NJ 07033, USA. Electronic address: [email protected].
²¹ Merck Research Labs, Merck & Co. Inc, 2000 Galloping Hill Road, Kenilworth, NJ 07033, USA. Electronic address: [email protected].
²² Merck Research Labs, Merck & Co. Inc, 2000 Galloping Hill Road, Kenilworth, NJ 07033, USA. Electronic address: [email protected].
²³ Medical Oncology, Yale University School of Medicine and Yale Cancer Center, 35 York Street, PO Box 208028, New Haven, CT 06510, USA. Electronic address: [email protected].

PMID: 35381576
DOI: 10.1016/j.oraloncology.2022.105815

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: 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.

Publication types

Clinical Trial, Phase III
Research Support, Non-U.S. Gov't

MeSH terms

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

Substances

Antibodies, Monoclonal, Humanized
pembrolizumab
Cetuximab

Associated data

ClinicalTrials.gov/NCT02358031

Grants and funding

28724/CRUK_/Cancer Research UK/United Kingdom