Yosefof Eyal, Edri Nofar, Ben-Nachum Idan, Yaniv Dan, Mizrachi Aviram, Asher Nethanel, Ben-Dor Naomi, Ben-Artzi Avital, Averbuch Itamar, Kurman Noga
Department of Otorhinolaryngology and Head and Neck Surgery, Rabin Medical Center-Beilinson Hospital, Petach Tikva 4941492, Israel.
Faculty of Medicine, Tel Aviv University, Tel Aviv 6997801, Israel.
Oncologist. 2025 Feb 6;30(2). doi: 10.1093/oncolo/oyaf022.
Programmed-cell death protein 1 (PD-1) inhibitors have emerged as a standard of care treatment among advanced-stage or metastatic cutaneous squamous cell carcinoma (cSCC). Immune-compromised patients and particularly solid organ transplant recipients (SOTRs) are considered at high risk for cSCC. When treated with PD-1 inhibitors, the possibility of organ rejection, autoimmune flare, or insufficient response to treatment is feared. As these patients were excluded from past prospective clinical trials, we aim to describe our institute's experience regarding these patients.
A retrospective analysis was conducted on cSCC patients treated with PD-1 inhibitors. Comparisons were made between immune-compromised and immune-competent groups, with a subgroup analysis of SOTR.
The study cohort comprised of 133 patients, including 97.8% receiving Cemiplimab with a mean age of 77.2 ± 11.7 years. Immune-compromised patients constituted 26.9% (n = 35) of the cohort, including 10 SOTR (all kidney transplant recipients). Objective response rates (ORRs) and disease control rates (DCR) were comparable between immunocompetent and immunosuppressed patients receiving Cemiplimab (ORR: 76.8% vs 62.9%, P = .12; DCR: 81.1% vs 68.6%, P = .13). SOTR demonstrated an 80% ORR and DCR. Progression-free survival was comparable across all groups. Toxicity rates were similar between immunosuppressed and immunocompetent subgroups (68.6% vs 62.1%, P = .5). Two OTRs (20%) experienced acute graft rejection.
PD-1 inhibitors demonstrate efficacy and safety in immunosuppressed cSCC patients. While effective in SOTR, treatment requires multidisciplinary management due to the potential risk of organ rejection. These findings provide valuable insights into this understudied population and support the use of PD-1 inhibitors in immunosuppressed patients with advanced cSCC.
程序性细胞死亡蛋白1（PD-1）抑制剂已成为晚期或转移性皮肤鳞状细胞癌（cSCC）的标准治疗方案。免疫功能低下的患者，尤其是实体器官移植受者（SOTR），被认为患cSCC的风险很高。在使用PD-1抑制剂治疗时，人们担心会出现器官排斥、自身免疫性炎症或治疗反应不足的情况。由于这些患者被排除在过去的前瞻性临床试验之外，我们旨在描述我们研究所对这些患者的治疗经验。
对接受PD-1抑制剂治疗的cSCC患者进行回顾性分析。对免疫功能低下组和免疫功能正常组进行比较，并对SOTR进行亚组分析。
研究队列包括133例患者，其中97.8%接受西米普利单抗治疗，平均年龄为77.2±11.7岁。免疫功能低下的患者占队列的26.9%（n = 35），其中包括10例SOTR（均为肾移植受者）。接受西米普利单抗治疗的免疫功能正常和免疫功能低下患者的客观缓解率（ORR）和疾病控制率（DCR）相当（ORR：76.8%对62.9%，P = 0.12；DCR：81.1%对68.6%，P = 0.13）。SOTR的ORR和DCR均为80%。所有组的无进展生存期相当。免疫抑制亚组和免疫功能正常亚组的毒性发生率相似（68.6%对62.1%，P = 0.5）。2例OTR（20%）发生急性移植物排斥反应。
PD-1抑制剂在免疫抑制的cSCC患者中显示出疗效和安全性。虽然对SOTR有效，但由于存在器官排斥的潜在风险，治疗需要多学科管理。这些发现为这一研究不足的人群提供了有价值的见解，并支持在免疫抑制的晚期cSCC患者中使用PD-1抑制剂。
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