Department of Oncology, Division of Medical Oncology, Schulich School of Medicine & Dentistry, Western University, London, ON, Canada.
London Regional Cancer Program, London Health Sciences Centre, Victoria Hospital, London, ON, Canada.
J Cutan Med Surg. 2024 Sep-Oct;28(5):453-457. doi: 10.1177/12034754241265696. Epub 2024 Jul 26.
Cutaneous squamous cell carcinoma (cSCC) is the second most common nonmelanoma skin cancer in Canada. However, few real-world reports exist on the treatment of refractory locally advanced (LA) and metastatic cSCC with cemiplimab to date.
The objective of this study was to characterize the demographic and clinical outcomes of advanced cSCC patients on cemiplimab in a real-world setting.
Retrospective analysis of adult patients with refractory LA and metastatic cSCC treated with cemiplimab at the London Regional Cancer Program in Canada. Patient demographics and treatment characteristics were reported, as well as Kaplan-Meier estimates of progression-free survival (PFS) and overall survival (OS).
Forty patients were included in this study. Sixteen (40%) had LA disease and 24 (60%) had metastatic disease. Median treatment duration was 3.5 months (range: 0.6-29.4 months). Kaplan-Meier analyses of the entire study population revealed that the median OS was not reached [NR; 95% confidence interval (CI) 9.1 months-NR], but median PFS was 11.5 months (95% CI 7.0 months-NR). A total of 25% of patients experienced at least one adverse event from cemiplimab. Reasons for treatment discontinuation were death from any cause (25%), disease progression (15%), cemiplimab adverse events (5%), and other causes (15%).
The 12 month estimates of OS and PFS were lower than pivotal phase I and II clinical trials. However, toxicity was tolerable. Cemiplimab remains a safe and effective therapy in patients with refractory LA and metastatic cSCC disease.
在加拿大,皮肤鳞状细胞癌(cSCC)是第二常见的非黑色素瘤皮肤癌。然而,迄今为止,关于西普单抗治疗难治性局部晚期(LA)和转移性 cSCC 的真实世界报告很少。
本研究的目的是描述在真实环境中接受西普单抗治疗的晚期 cSCC 患者的人口统计学和临床结局。
对加拿大伦敦地区癌症项目接受西普单抗治疗的难治性 LA 和转移性 cSCC 成年患者进行回顾性分析。报告了患者的人口统计学和治疗特征,以及无进展生存期(PFS)和总生存期(OS)的 Kaplan-Meier 估计。
本研究纳入了 40 名患者。16 名(40%)患者患有 LA 疾病,24 名(60%)患者患有转移性疾病。中位治疗持续时间为 3.5 个月(范围:0.6-29.4 个月)。整个研究人群的 Kaplan-Meier 分析显示,中位 OS 未达到[NR;95%置信区间(CI)9.1 个月-NR],但中位 PFS 为 11.5 个月(95%CI 7.0 个月-NR)。共有 25%的患者经历了至少一次西普单抗相关不良事件。停止治疗的原因包括任何原因导致的死亡(25%)、疾病进展(15%)、西普单抗相关不良事件(5%)和其他原因(15%)。
OS 和 PFS 的 12 个月估计值低于关键的 I 期和 II 期临床试验。然而,毒性是可以耐受的。西普单抗仍然是难治性 LA 和转移性 cSCC 疾病患者安全有效的治疗选择。