Kuzmanovszki Daniella, Kiss Norbert, Tóth Béla, Tóth Veronika, Szakonyi József, Lőrincz Kende, Hársing Judit, Kuroli Enikő, Imrédi Eleonóra, Kerner Tünde, Patyánik Mihály, Wikonkál Norbert M, Szabó Ákos, Brodszky Valentin, Rencz Fanni, Holló Péter
Department of Dermatology, Venereology and Dermatooncology, Faculty of Medicine, Semmelweis University, H-1085 Budapest, Hungary.
Uzsoki Street Hospital, Practice Hospital of the Faculty of General Medicine, Semmelweis University, H-1145 Budapest, Hungary.
J Clin Med. 2023 Sep 14;12(18):5966. doi: 10.3390/jcm12185966.
The systemic treatment of advanced cutaneous squamous cell carcinoma (cSCC) has seen significant developments in recent years. The anti-PD1 inhibitor cemiplimab has demonstrated efficacy in clinical trials, but real-world data are still limited. Here, we aimed to evaluate the efficacy and the safety of cemiplimab in a real-world clinical setting.
A retrospective analysis was carried out for all patients who received at least two doses of cemiplimab at our department between February 2020 and January 2023. Progression-free survival (PFS), overall survival (OS), the objective response rate (ORR), the disease control rate (DCR) and adverse events (AEs) were evaluated.
Twenty-five patients were included with a median age of 78 (65-82) years. The median treatment duration was 48 (16-72) weeks. Five (20%) patients were immunocompromised. Sixteen patients (64%) developed AEs, including 36% serious AEs (SAEs) of grade ≥ 3. Six patients (24%) were withdrawn from treatment due to the occurrence of AEs. Among the 25 patients, 52% showed an objective response (3 complete and 10 partial responses), 76% had controlled disease and 24% experienced progression. Among the five immunocompromised patients, the ORR was 60%, while the DCR was 80%.
This retrospective real-world study revealed that locally advanced or metastatic cSCC could be effectively treated with cemiplimab even in elderly, polymorbid and immunocompromised patients.
近年来,晚期皮肤鳞状细胞癌(cSCC)的系统治疗取得了显著进展。抗PD1抑制剂西米普利单抗在临床试验中已显示出疗效,但真实世界的数据仍然有限。在此,我们旨在评估西米普利单抗在真实世界临床环境中的疗效和安全性。
对2020年2月至2023年1月期间在我科接受至少两剂西米普利单抗治疗的所有患者进行回顾性分析。评估无进展生存期(PFS)、总生存期(OS)、客观缓解率(ORR)、疾病控制率(DCR)和不良事件(AE)。
纳入25例患者,中位年龄为78(65 - 82)岁。中位治疗持续时间为48(16 - 72)周。5例(20%)患者存在免疫功能低下。16例患者(64%)发生了AE,其中36%为≥3级严重AE(SAE)。6例患者(24%)因AE发生而退出治疗。在这25例患者中,52%表现出客观缓解(3例完全缓解和10例部分缓解),76%疾病得到控制,24%疾病进展。在5例免疫功能低下的患者中,ORR为60%,而DCR为80%。
这项回顾性真实世界研究表明,即使在老年、多病和免疫功能低下的患者中,西米普利单抗也可有效治疗局部晚期或转移性cSCC。