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Multicenter Study
. 2025 Sep 21:64:1269-1275.
doi: 10.2340/1651-226X.2025.44327.

Pembrolizumab as first-line treatment for recurrent or metastatic head and neck squamous cell carcinoma: a multi-institutional DAHANCA cohort study

Sebastian Søby  1 , Robin Prestwich  2 , Niels Gyldenkerne  3 , Christian Maare  4 , Camilla K Lonkvist  4 , Maria Andersen  5 , Kinga Nowicka-Matus  5 , Anita Gothelf  6 , Trine Tramm  7 , Kasper Toustrup  8 , Simion Mihaela  2 , Danny Ulahannan  2 , Zsuzsanna Iyizoba-Ebozue  9 , Jesper G Eriksen  10
Affiliations
Multicenter Study

Pembrolizumab as first-line treatment for recurrent or metastatic head and neck squamous cell carcinoma: a multi-institutional DAHANCA cohort study

Sebastian Søby et al. Acta Oncol. .

Abstract

Background and purpose: Pembrolizumab is frequently used for recurrent or metastatic head and neck squamous cell carcinoma (rmHNSCC) as first-line treatment. This study evaluates real-world effectiveness in a Danish and United Kingdom (UK) cohort. Patient/material and methods: Patients with confirmed rmHNSCC treated with pembrolizumab (2020-2024) as first-line palliative treatment were included consecutively. Data were collected from patient files at four Danish head and neck cancer centres (discovery cohort) and the Leeds Teaching Hospitals NHS Trust (comparison cohort). Primary endpoints were overall survival (OS) and progression-free survival (PFS).

Results: In the discovery cohort (n = 228), a median OS of 10 months (95% [confidence interval [CI]: 10-12) and median PFS of 4 months (95% CI: 4-6) were found. Primary endpoints did not differ significantly between the discovery and comparison cohort. Baseline World Health Organization performance status appeared to negatively impact endpoints (hazard ratio: 1.4 [95% CI: 1.0-2.0]).

Interpretation: In this real-world multi-centre study, pembrolizumab demonstrated efficacy equivalent to the registration studies in two independent cohorts.

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Conflict of interest statement

The authors report there are no competing interests to declare.

Figures

Figure 1
Figure 1
Overall survival (1A) and progression-free survival (1B) by patient cohort.
Figure 2
Figure 2
Overall survival (2A) and progression-free survival (2B) by WHO PS at baseline. WHO PS: World Health Organization performance status.
Figure 3
Figure 3
Overall survival (3A) and progression-free survival (3B) by pre-treatment CPS PD-L1 expression. CPS: combined positive score.
Figure 4
Figure 4
Overall survival (4A) and progression-free survival (4B) by neutrophilia at baseline.
See this image and copyright information in PMC

References

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    1. Vasiliadou I, Grose D, Wilson C, Thapa A, Donnelly O, Lee E, et al. The use of pembrolizumab monotherapy for the management of head and neck squamous cell carcinoma (HNSCC) in the UK. Int J Cancer. 2024;155(5):883–93. 10.1002/ijc.34963 - DOI - PubMed
    1. Søby S, Gothelf A, Gyldenkerne N, Bentzen J, Nowicka-Matus K, Tramm T, et al. Efficacy of nivolumab as second line treatment for recurrent or metastatic head and neck squamous cell carcinoma: a national DAHANCA cohort study. Acta Oncol. 2022;61(8):972–8. 10.1080/0284186X.2022.2103387 - DOI - PubMed
    1. Kenilworth NJ. FDA approves Merck’s Keytruda (pembrolizumab) for use at an additional recommended dose of 400 mg every six weeks for all approved adult indications [Internet]. [cited 2025 Jan 21]. Available from: https://www.drugs.com/newdrugs/fda-approves-merck-s-keytruda-pembrolizum...

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