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

Sebastian Søby; Robin Prestwich; Niels Gyldenkerne; Christian Maare; Camilla K. Lonkvist; Maria Andersen; Kinga Nowicka-Matus; Anita Gothelf; Trine Tramm; Kasper Toustrup; Simion Mihaela; Danny Ulahannan; Zsuzsanna Iyizoba-Ebozue; Jesper G. Eriksen

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, Robin Prestwich, Niels Gyldenkerne, Christian Maare, Camilla K. Lonkvist, Maria Andersen, Kinga Nowicka-Matus, Anita Gothelf, Trine Tramm, Kasper Toustrup, Simion Mihaela, Danny Ulahannan, Zsuzsanna Iyizoba-Ebozue, Jesper G. Eriksen

Department of Oncology

1 Citation (Scopus)

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.

Original language	English
Journal	Acta oncologica (Stockholm, Sweden)
Volume	64
Pages (from-to)	1269-1275
Number of pages	7
ISSN	0284-186X
DOIs	https://doi.org/10.2340/1651-226X.2025.44327
Publication status	Published - 21 Sept 2025

Keywords

B7-H1 antigen (D060890)
Pembrolizumab (C582435)
clinical trials, Phase IV as topic (D017327)
head and neck neoplasms (D006258)
palliative medicine (D065126)

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Søby, S., Prestwich, R., Gyldenkerne, N., Maare, C., Lonkvist, C. K., Andersen, M., Nowicka-Matus, K., Gothelf, A., Tramm, T., Toustrup, K., Mihaela, S., Ulahannan, D., Iyizoba-Ebozue, Z., & Eriksen, J. G. (2025). Pembrolizumab as first-line treatment for recurrent or metastatic head and neck squamous cell carcinoma: a multi-institutional DAHANCA cohort study. Acta oncologica (Stockholm, Sweden), 64, 1269-1275. https://doi.org/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. / Søby, Sebastian; Prestwich, Robin; Gyldenkerne, Niels et al.
In: Acta oncologica (Stockholm, Sweden), Vol. 64, 21.09.2025, p. 1269-1275.

Research output: Contribution to journal › Journal article › Research › peer-review

Søby, S, Prestwich, R, Gyldenkerne, N, Maare, C , Lonkvist, CK, Andersen, M, Nowicka-Matus, K, Gothelf, A, Tramm, T, Toustrup, K, Mihaela, S, Ulahannan, D, Iyizoba-Ebozue, Z & Eriksen, JG 2025, 'Pembrolizumab as first-line treatment for recurrent or metastatic head and neck squamous cell carcinoma: a multi-institutional DAHANCA cohort study', Acta oncologica (Stockholm, Sweden), vol. 64, pp. 1269-1275. https://doi.org/10.2340/1651-226X.2025.44327

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

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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doi = "10.2340/1651-226X.2025.44327",

language = "English",

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T1 - Pembrolizumab as first-line treatment for recurrent or metastatic head and neck squamous cell carcinoma

T2 - a multi-institutional DAHANCA cohort study

AU - Søby, Sebastian

AU - Prestwich, Robin

AU - Gyldenkerne, Niels

AU - Maare, Christian

AU - Lonkvist, Camilla K.

AU - Andersen, Maria

AU - Nowicka-Matus, Kinga

AU - Gothelf, Anita

AU - Tramm, Trine

AU - Toustrup, Kasper

AU - Mihaela, Simion

AU - Ulahannan, Danny

AU - Iyizoba-Ebozue, Zsuzsanna

AU - Eriksen, Jesper G.

PY - 2025/9/21

Y1 - 2025/9/21

N2 - 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.

AB - 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.

KW - B7-H1 antigen (D060890)

KW - Pembrolizumab (C582435)

KW - clinical trials, Phase IV as topic (D017327)

KW - head and neck neoplasms (D006258)

KW - palliative medicine (D065126)

UR - https://www.scopus.com/pages/publications/105016768241

U2 - 10.2340/1651-226X.2025.44327

DO - 10.2340/1651-226X.2025.44327

M3 - Journal article

C2 - 40976915

AN - SCOPUS:105016768241

SN - 0284-186X

VL - 64

SP - 1269

EP - 1275

JO - Acta oncologica (Stockholm, Sweden)

JF - Acta oncologica (Stockholm, Sweden)

ER -

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

Abstract

Keywords

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