The use of pembrolizumab monotherapy for the management of head and neck squamous cell carcinoma (HNSCC) in the UK.
Date
2024-09-01Author
Vasiliadou, I
Grose, D
Wilson, C
Thapa, A
Donnelly, O
Lee, E
Leslie, I
Karim, M
Hartley, A
Partridge, S
Medlow, K
De Boisanger, J
Metcalf, R
Williamson, A
Haridass, A
Noble, D
Mactier, K
Walter, H
Ma, N
De Winton, E
Cohen, J
Rayner, L
Geropantas, K
Jankowska, P
Mason, J
Moleron, R
Laws, K
Ulahannan, D
Nallathambi, C
Michaelidou, A
Nallamilli, S
Raouf, S
Palmer, K
Bienz, M
Karet, T
Khalique, S
Paterson, C
Harrington, K
Bhide, S
Kong, A
Type
Journal Article
Metadata
Show full item recordAbstract
Pembrolizumab has received approval in the UK as first-line monotherapy for recurrent and/or metastatic HNSCC (R/M HNSCC) following the results of the KEYNOTE-048 trial, which demonstrated a longer overall survival (OS) in comparison to the EXTREME chemotherapy regimen in patients with a combined positive score (CPS) ≥1. In this article, we provide retrospective real-world data on the role of pembrolizumab monotherapy as first-line systemic therapy for HNSCC across 18 centers in the UK from March 20, 2020 to May 31, 2021. 211 patients were included, and in the efficacy analysis, the objective response rate (ORR) was 24.7%, the median progression-free survival (PFS) was 4.8 months (95% confidence interval [CI]: 3.6-6.1), and the median OS was 10.8 months (95% CI 9.0-12.5). Pembrolizumab monotherapy was well tolerated, with 18 patients having to stop treatment owing to immune-related adverse events (irAEs). 53 patients proceeded to second-line treatment with a median PFS2 of 10.2 months (95% CI: 8.8-11.5). Moreover, patients with documented irAEs had a statistically significant longer median PFS (11.3 vs. 3.3 months; log-rank p value = <.001) and median OS (18.8 vs. 8.9 months; log-rank p value <.001). The efficacy and safety of pembrolizumab first-line monotherapy for HNSCC has been validated using real-world data.
Collections
Subject
head and neck squamous cell carcinoma
immune‐related adverse events
immunotherapy
pembrolizumab
real‐world data
recurrent/metastatic HNSCC
systemic treatment
Humans
Antibodies, Monoclonal, Humanized
Male
Female
Squamous Cell Carcinoma of Head and Neck
Middle Aged
Aged
Retrospective Studies
United Kingdom
Head and Neck Neoplasms
Adult
Aged, 80 and over
Antineoplastic Agents, Immunological
Progression-Free Survival
Research team
Targeted Therapy
Functional Genomics
Language
eng
Date accepted
2024-01-11
License start date
2024-09-01
Citation
International Journal of Cancer, 2024, 155 (5), pp. 883 - 893
Publisher
WILEY