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一线与二线西米普利单抗治疗晚期基底细胞癌的真实世界经验。

Real-world experience with first- versus second-line cemiplimab for advanced basal cell carcinoma.

作者信息

DeTemple Viola K, Kaatz Martin, Stockfleth Eggert, Scheel Christina, Angela Yenny, Gutzmer Ralf, Leiter Ulrike, Meier Friedegund, Schadendorf Dirk, Livingstone Elisabeth, Gebhardt Christoffer, von Wasielewski Imke, Weichenthal Michael, Mohr Peter, Hassel Jessica, Pföhler Claudia, Simon Jan Christoph, Jochims Franziska, Terheyden Patrick, Ulrich Jens, Haferkamp Sebastian, Drexler Konstantin, Schilling Bastian, Glutsch Valerie, Heinzerling Lucie, Berking Carola, Ugurel Selma, Tomsitz Dirk

机构信息

Department of Dermatology, Johannes Wesling Medical Center Minden, Ruhr University Bochum, Minden, Germany.

Department of Dermatology, SRH Wald-Hospital Gera, Gera, Germany; Department of Dermatology, DRK Hospital Chemnitz-Rabenstein, Rabenstein, Germany.

出版信息

Eur J Cancer. 2025 Jul 25;225:115590. doi: 10.1016/j.ejca.2025.115590. Epub 2025 Jun 24.

Abstract

BACKGROUND

The anti-PD1 antibody (PD1i) cemiplimab is approved as second-line treatment for locally advanced or metastatic basal cell carcinoma (BCC), resulting in an ORR of 20-30 %. This study aimed to investigate the efficacy of cemiplimab as first-line or second-line treatment of BCC in a German real-world patient cohort.

METHODS

Patients with histologically confirmed locally advanced or metastatic BCC who were treated with cemiplimab were retrospectively identified from the prospective multicenter real-world skin cancer registry ADOREG. Study endpoints were overall response rate (ORR), progression-free survival (PFS), and overall survival (OS). Therapy outcome was compared between patients receiving first-line cemiplimab and patients treated with cemiplimab in second-line.

RESULTS

37 patients from 17 skin cancer centers were identified who received cemiplimab. The median follow-up after start of any first-line treatment was 37.1 months, and 17.9 months after initiation of any cemiplimab treatment. Patients who received first-line cemiplimab (n = 8) had an ORR of 62.5 %, compared to an ORR of 31.0 % for patients who received second-line cemiplimab (n = 29); Median PFS was 19.8 months for first-line cemiplimab and 5.3 months for second-line cemiplimab. Reinduction with HHIs after progression on second-line cemiplimab resulted in an ORR of 20.0 % and a median PFS of 3.8 months.

CONCLUSION

We demonstrate a comparable outcome for cemiplimab as second-line treatment of BCC in our real-world patient cohort as reported in previous registration studies. Additionally, we found a trend for a more favorable outcome in first-line therapy, suggesting a rationale to further investigate cemiplimab as first-line treatment of advanced BCC.

摘要

背景

抗程序性死亡蛋白1(PD1)抗体西米普利单抗已被批准作为局部晚期或转移性基底细胞癌(BCC)的二线治疗药物,客观缓解率(ORR)为20%-30%。本研究旨在调查西米普利单抗在德国真实世界患者队列中作为BCC一线或二线治疗的疗效。

方法

从前瞻性多中心真实世界皮肤癌登记处ADOREG中回顾性识别出接受西米普利单抗治疗的组织学确诊的局部晚期或转移性BCC患者。研究终点为总缓解率(ORR)、无进展生存期(PFS)和总生存期(OS)。比较接受一线西米普利单抗治疗的患者和接受二线西米普利单抗治疗的患者的治疗结果。

结果

确定了来自17个皮肤癌中心的37例接受西米普利单抗治疗的患者。任何一线治疗开始后的中位随访时间为37.1个月,任何西米普利单抗治疗开始后的中位随访时间为17.9个月。接受一线西米普利单抗治疗的患者(n = 8)的ORR为62.5%,而接受二线西米普利单抗治疗的患者(n = 29)的ORR为31.0%;一线西米普利单抗治疗的中位PFS为19.8个月,二线西米普利单抗治疗的中位PFS为5.3个月。二线西米普利单抗治疗进展后用 Hedgehog通路抑制剂(HHIs)再次诱导治疗的ORR为20.0%,中位PFS为3.8个月。

结论

我们在真实世界患者队列中证明,西米普利单抗作为BCC二线治疗的结果与先前注册研究报告的结果相当。此外,我们发现一线治疗有更有利结果的趋势,这为进一步研究西米普利单抗作为晚期BCC的一线治疗提供了理论依据。

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