Efficacy and safety of cemiplimab in cutaneous squamous cell carcinoma on chronic wounds: A French retrospective study

M. Antoszczak , E. Maubec , A.-B. Duval-Modeste , A. Jannic , C. Jacobzone-Leveque , R. Lesbazeilles , F. Skowron , D. Solub , J. Ancel , L. Mortier , M. Viguier
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Abstract

Background

Chronic wounds increase the risk of the development of cutaneous squamous cell carcinoma (SCC), often resulting in poor prognosis in part because of delayed diagnosis. Cemiplimab, an anti-PD-1 agent, is recommended as first-line treatment for metastatic or locally advanced SCC not eligible for curative surgery, chemotherapy or radiation. However, its efficacy in SCC originating from chronic wounds remains uncertain.

Objective

This retrospective study assessed the efficacy and safety of cemiplimab in patients with SCC originating from chronic wounds.

Methods

We included patients receiving cemiplimab for SCC on chronic wounds between August 2018 and January 2021. The primary endpoint was progression-free survival (PFS) determined by Kaplan-Meier analysis. Secondary endpoints included response rate and safety.

Results

We included 17 patients, predominantly female (59 %), with median age 58 years (interquartile range 49–77). SCC typically originated from leg ulcers (47 %) and presented at locally advanced (41 %) or metastatic stage (41 %). With cemiplimab, often received as third-line therapy (41 %), the median PFS was 6.1 months (95 % confidence interval [CI], 2.97–7.70), with the best response rate 47 % and complete response rate 12 %. We found immune-related adverse events in 24 % of cases. Short PFS was associated with distant metastasis at treatment initiation.

Conclusion

Despite response rates comparable to other SCC types, median PFS was low with cemiplimab treatment for SCC originating from chronic wounds, likely due to the aggressive nature and/or high frequency of altered performance status. Anti-PD-1 therapy remains a primary treatment option for inoperable cases. Further prospective studies are warranted to confirm these findings and optimize treatment strategies.
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cemiplimab对慢性伤口皮肤鳞状细胞癌的疗效和安全性:法国的一项回顾性研究
背景慢性伤口增加了皮肤鳞状细胞癌(SCC)的发病风险,通常导致预后不良,部分原因是诊断延迟。对于不符合根治性手术、化疗或放疗条件的转移性或局部晚期SCC,建议将抗PD-1药物Cemiplimab作为一线治疗药物。本回顾性研究评估了塞米普利单抗在慢性伤口SCC患者中的疗效和安全性。方法我们纳入了2018年8月至2021年1月期间接受塞米普利单抗治疗慢性伤口SCC的患者。主要终点是无进展生存期(PFS),通过卡普兰-梅耶分析确定。次要终点包括反应率和安全性。结果我们纳入了17名患者,主要为女性(59%),中位年龄为58岁(四分位数间距为49-77)。SCC通常源于腿部溃疡(47%),处于局部晚期(41%)或转移期(41%)。塞米普利单抗通常作为三线疗法(41%),中位生存期为 6.1 个月(95% 置信区间 [CI],2.97-7.70),最佳反应率为 47%,完全反应率为 12%。我们在24%的病例中发现了与免疫相关的不良反应。结论尽管反应率与其他类型的SCC相当,但对慢性伤口引起的SCC进行cemiplimab治疗的中位PFS较低,这可能是由于其侵袭性和/或高频率的表现状态改变所致。抗PD-1疗法仍是无法手术病例的主要治疗方案。有必要进一步开展前瞻性研究,以证实这些发现并优化治疗策略。
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