Søby Sebastian, Prestwich Robin, Gyldenkerne Niels, Maare Christian, Lonkvist Camilla K, Andersen Maria, Nowicka-Matus Kinga, Gothelf Anita, Tramm Trine, Toustrup Kasper, Mihaela Simion, Ulahannan Danny, Iyizoba-Ebozue Zsuzsanna, Eriksen Jesper G
Aarhus University Hospital, Department of Experimental Clinical Oncology, Aarhus, Denmark; Aarhus University, Department of Clinical Medicine, Aarhus, Denmark.
St. James University Hospital, Leeds Cancer Center, Leeds, England.
Acta Oncol. 2025 Sep 21;64:1269-1275. doi: 10.2340/1651-226X.2025.44327.
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).
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]).
In this real-world multi-centre study, pembrolizumab demonstrated efficacy equivalent to the registration studies in two independent cohorts.
帕博利珠单抗常用于复发性或转移性头颈部鳞状细胞癌（rmHNSCC）的一线治疗。本研究评估了丹麦和英国队列中的真实疗效。患者/材料与方法：连续纳入2020年至2024年接受帕博利珠单抗一线姑息治疗的确诊rmHNSCC患者。数据从四个丹麦头颈癌中心（发现队列）和利兹教学医院国民保健服务信托基金（比较队列）的患者档案中收集。主要终点为总生存期（OS）和无进展生存期（PFS）。
在发现队列（n = 228）中，中位总生存期为10个月（95%[置信区间[CI]：10 - 12），中位无进展生存期为4个月（95% CI：4 - 6）。发现队列和比较队列之间的主要终点无显著差异。基线世界卫生组织体能状态似乎对终点有负面影响（风险比：1.4[95% CI：1.0 - 2.0]）。
在这项真实世界的多中心研究中，帕博利珠单抗在两个独立队列中显示出与注册研究相当的疗效。
