文章：

晚期皮肤鳞状细胞癌中的免疫检查点抑制剂：来自加拿大综合癌症中心的真实世界经验

Immune Checkpoint Inhibitors in Advanced Cutaneous Squamous Cell Carcinoma: Real-World Experience from a Canadian Comprehensive Cancer Centre

原文发布日期：29 August 2023

DOI: 10.3390/cancers15174312

类型: Article

开放获取: 是

英文摘要：

Immune checkpoint inhibitors (ICI) cemiplimab and pembrolizumab have revolutionized the treatment of advanced cutaneous squamous cell carcinoma (cSCC). We aimed to evaluate the effectiveness and safety of ICI in a real-world cSCC population, including patients with conditions that would exclude clinical trial participation. In this single-center, retrospective cohort study, we included all non-trial patients with advanced cSCC treated with ICI between 2017 and 2022. We evaluated investigator-assessed best overall response (BOR) and immune-related adverse events (irAEs). We correlated survival outcomes with age, performance status, immune status and irAEs. Of the 36 patients identified, the best overall response (BOR) to ICI was a partial response (PR) in 41.7%, a complete response (CR) in 27.8%, and stable disease in (SD) 13.9%. The progression-free survival (PFS) rate for 1 year was 58.1%; the median PFS was 21.3 months (95% CI 6.4–NE). The 1-year overall survival (OS) was 76.7%, and the median OS was 38.6 months (95% CI 25.4–NE). Immune-compromised patients, ECOG performance 2–3, and age ≥ 75 years were not significantly associated with PFS or OS. IrAE grades 3–4 were seen in 13.9% of patients. In our Canadian experience with real-world patients, ICI was an effective and safe treatment for advanced cSCC patients. Patients achieved great benefits with ICI regardless of age, immune status or ECOG performance status. We acknowledge the small sample size and retrospective methodology as the main limitations of our study.

摘要翻译： 

免疫检查点抑制剂（ICI）西米普利单抗和帕博利珠单抗已彻底改变了晚期皮肤鳞状细胞癌（cSCC）的治疗格局。本研究旨在评估ICI在真实世界cSCC人群中的有效性和安全性，该人群包括不符合临床试验入组条件的患者。在这项单中心回顾性队列研究中，我们纳入了2017年至2022年间所有接受ICI治疗的非临床试验晚期cSCC患者。评估指标包括研究者判定的最佳总体缓解（BOR）和免疫相关不良事件（irAEs），并分析生存结局与年龄、体能状态、免疫状态及irAEs的相关性。在纳入的36例患者中，ICI治疗的最佳总体缓解情况为：部分缓解（PR）占41.7%，完全缓解（CR）占27.8%，疾病稳定（SD）占13.9%。1年无进展生存（PFS）率为58.1%，中位PFS为21.3个月（95% CI 6.4-未达到）。1年总生存（OS）率为76.7%，中位OS为38.6个月（95% CI 25.4-未达到）。免疫功能低下、ECOG体能状态评分2-3分及年龄≥75岁与PFS或OS均无显著相关性。13.9%的患者出现3-4级irAEs。基于加拿大真实世界患者的治疗经验，ICI是晚期cSCC患者有效且安全的治疗方案。无论年龄、免疫状态或ECOG体能状态如何，患者均能从ICI治疗中显著获益。本研究的主要局限性在于样本量较小且采用回顾性研究方法。

原文链接：

Immune Checkpoint Inhibitors in Advanced Cutaneous Squamous Cell Carcinoma: Real-World Experience from a Canadian Comprehensive Cancer Centre