Eur J Cancer:Cemiplimab治疗局部晚期/转移性皮肤鳞状细胞癌的真实数据

2021-09-22 xiaozeng MedSci原创

Cemiplimab 治疗真实临床晚期 cSCC 患者的安全性和有效性结果与临床试验中获得的结果一致

皮肤鳞状细胞癌 (cSCC) 患者的总体预后良好,但晚期疾病患者除外。程序性死亡蛋白-1(PD-1)抑制剂 Cemiplimab(Libtayo,西米普利单抗)已获批用于晚期 cSCC。

本文报告了意大利晚期 cSCC 患者采用 Cemiplimab 治疗的真实临床结果。

这是一项回顾性、观察性的多中心研究,分析了于 2019年 5 月至 2020 年 2 月在意大利 17 个医疗中心接受 Cemiplimab 治疗的晚期 cSCC 患者的医疗记录,评估了 Cemiplimab 治疗的安全性、临床活性(缓解率)、临床获益和缓解持续时间,以及与缓解相关的基础临床病理特征。

不良事件

共纳入了 131 位患者,中位年龄为 79 岁。其中,9.2% 的患者同时合并慢性淋巴增生性疾病,8.5% 的患者伴有自身免疫病。42.7% 的患者至少发生了一次治疗相关的不良事件(AE),其中,9.2% 的发生了 3-4 级不良事件,并且有两例致命的不良事件。

最佳缓解情况

总缓解率(ORR)为 58%,疾病控制率(DCR)为 71.7%。在头颈部区域的皮肤鳞状细胞癌(cSCC)和正常范围的血红蛋白值与对 Cemiplimab 更好的反应相关(p值分别是0.007和0.034);而生殖器区域的 cSCC(p=0.041)、在开始 Cemiplimab 治疗的一个月内全是应用抗生素(p=0.012)、表现状态≥1分(p=0.012)、长期糖皮质激素治疗(p=0.052)和既往化疗(p=0.0020)都与反应较差显著相关。

综上所述,该真实世界研究显示的 Cemiplimab 治疗晚期 cSCC 的安全性和有效性结果与临床试验中获得的结果一致。此外,该研究还确定了一些可能与 Cemiplimab 反应相关的临床和生化因素。

原始出处:

Baggi Alice,Quaglino Pietro,Rubatto Marco et al. Real world data of cemiplimab in locally advanced and metastatic cutaneous squamous cell carcinoma.[J] .Eur J Cancer, 2021, 157: 250-258.

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    2022-01-02 zlawrance
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    2021-12-03 snf701207
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    2021-09-24 chg122

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