Bristol Haematology and Oncology Centre, University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, United Kingdom.
Department of Clinical Oncology, Royal Cornwall Hospital, Truro, United Kingdom.
Front Immunol. 2024 Jul 12;15:1408667. doi: 10.3389/fimmu.2024.1408667. eCollection 2024.
Cemiplimab was licensed in the United Kingdom (UK) in 2019 for the treatment of patients with locally advanced and metastatic CSCC not suitable for curative surgery or radiotherapy (advanced CSCC [aCSCC]). No UK multi-center studies have investigated the real-world experience of cemiplimab post marketing authorization in aCSCC.
This non-interventional retrospective study (10 UK centers) involved data collection from medical records of patients with aCSCC who initiated cemiplimab treatment between 2 July 2019 and 30 November 2020. The study period was a minimum of 12 and a maximum of 36 months post cemiplimab initiation. The primary objective was to describe the real-world clinical effectiveness of cemiplimab (primary outcome: overall response rate [ORR]).
Of 105 patients, 70% (n=73/105) were male (median [range] age at index of 78.5 [55.4-93.2] years); most patients (63% [n=50/80]) had an Eastern Cooperative Oncology Group (ECOG) score of 1 and 62% (n=63/102) had metastatic disease. The ORR within 12 months was 42% (95% confidence interval [CI] 32%-51%) and the disease control rate was 62% (n=65/105). The median (95% CI) real-world progression-free survival and overall survival from index was 8.6 (6.0-18.7) and 21.0 (14.7-25.2) months, respectively. The median (range) number of cemiplimab infusions was 11.0 (1.0-44.0). Eighty-seven percent experienced no cemiplimab treatment interruptions; 13% (n=14/105) interrupted treatment due to immune-related adverse reactions (irARs) (47% [n=9/19] of treatment interruption events). Eighty-five percent (n=89/105) of patients had discontinued cemiplimab treatment by the end of the study; where reasons for discontinuation were recorded, 20% (n=17/87) discontinued due to the completion of their 2-year treatment course. Nineteen percent (n=20/105) of patients experienced irARs.
Effectiveness and safety data in this study are broadly similar to previous real-world studies of cemiplimab and the EMPOWER-CSCC1 clinical trial; with our cohort representing a broader population (included immunocompromised and transplant patients). Results support the use of cemiplimab for the treatment of aCSCC in a real-world setting.
西妥昔单抗于 2019 年在英国（英国）获得批准，用于治疗不适合根治性手术或放疗的局部晚期和转移性 CSCC 患者（晚期 CSCC[aCSCC]）。在英国，没有多中心研究调查过西妥昔单抗上市后的真实世界经验。
本非干预性回顾性研究（10 个英国中心）涉及从 2019 年 7 月 2 日至 2020 年 11 月 30 日期间接受西妥昔单抗治疗的 aCSCC 患者的病历中收集数据。研究期间至少为 12 个月，最长为 36 个月。主要目的是描述西妥昔单抗的真实世界临床疗效（主要结局：总缓解率[ORR]）。
在 105 例患者中，70%（n=73/105）为男性（指数年龄中位数[范围]为 78.5[55.4-93.2]岁）；大多数患者（63%[n=50/80]）ECOG 评分为 1，62%（n=63/102）有转移病灶。12 个月内的 ORR 为 42%（95%置信区间[CI]32%-51%），疾病控制率为 62%（n=65/105）。从指数开始的中位（95%CI）真实世界无进展生存期和总生存期分别为 8.6（6.0-18.7）和 21.0（14.7-25.2）个月。中位（范围）西妥昔单抗输注次数为 11.0（1.0-44.0）。87%的患者未中断西妥昔单抗治疗；13%（n=14/105）因免疫相关不良反应（irAR）中断治疗（治疗中断事件的 47%[n=9/19]）。研究结束时，85%（n=89/105）的患者已停止西妥昔单抗治疗；记录了停药原因，20%（n=17/87）因完成 2 年治疗疗程而停药。19%（n=20/105）的患者出现 irAR。
本研究的有效性和安全性数据与西妥昔单抗之前的真实世界研究和 EMPOWER-CSCC1 临床试验大致相似；我们的队列代表了更广泛的人群（包括免疫功能低下和移植患者）。结果支持在真实环境中使用西妥昔单抗治疗 aCSCC。
