The use of pembrolizumab monotherapy for the management of head and neck squamous cell carcinoma (HNSCC) in the UK.
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Authors
Vasiliadou, Ifigenia
Grose, Derek
Wilson, Christina
Thapa, Alekh
Donnelly, Olly
Lee, Elsa
Leslie, Isla
Karim, Mahwish
Hartley, Andrew
Partridge, Sarah
Issue Date
2024-09-29
Type
Journal Article
Language
en
Keywords
head and neck squamous cell carcinoma , immune‐related adverse events , immunotherapy , pembrolizumab , real‐world data , recurrent/metastatic HNSCC , systemic treatment
Alternative Title
Abstract
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.
Description
This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium,provided the original work is properly cited.© 2024 The Authors. International Journal of Cancer published by John Wiley & Sons Ltd on behalf of UICC.
Citation
Vasiliadou, I.; Grose, D.; Wilson, C.; Thapa, A.; Donnelly, O.; Lee, E.; Leslie, I.; Karim, M.; Hartley, A.; Partridge, S.; Medlow, K.; Boisanger, JD.; Metcalf, R.; Williamson, A.; Haridass, A.; Noble, D.; Mactier, K.; Walter, H.; Ma, N.; Winton, ED.; 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. and Kong, A. 'The use of pembrolizumab monotherapy for the management of head and neck squamous cell carcinoma (HNSCC) in the UK', International Journal of Cancer, 155(5) pp. 883-893. Available at: https://doi.org/10.1002/ijc.34963
Publisher
Wiley
License
© 2024 The Authors. International Journal of Cancer published by John Wiley & Sons Ltd on behalf of UICC.
Journal
International journal of cancer
Volume
155
Issue
5
PubMed ID
ISSN
1097-0215