肾移植受者(KTR)由于长期免疫抑制治疗而面临癌症风险增加。非黑素皮肤癌相较于一般人群，风险增加约250倍。此外，在固体器官移植受者(SOTR)中，这些癌症的行为更具侵袭性，有着转移和死亡的风险增加。Cemiplimab是一种针对程序化细胞死亡(PD-1)的人源单克隆IgG4抗体，已在转移性和局部晚期皮肤鳞状细胞癌(cSCC)患者中显示出显著的临床活性，而这种癌症在目前还没有广泛接受的治疗标准。因此，Cemiplimab自2018年起被批准用于治疗晚期cSCC。然而，在SOTR和特别是KTR中使用Cemiplimab的数据非常有限，主要依靠已发表的病例报告和小型病例系列。在本研究中，我们报告了比利时7名患有晚期cSCC的KTR使用Cemiplimab的实际效果。报告比利时KTR中Cemiplimab的整体反应率(ORR)和安全性。在比利时，我们确定了2018年至2022年间接受Cemiplimab治疗的7名晚期cSCC患者。其中3名患者接受类固醇单药治疗，1名患者接受他克莫司单药治疗，而3名患者在Cemiplimab开始时至少使用了2种免疫抑制剂。结果显示，ORR为42.8％，稳定病例占14.3％，进展病例占42.8％。接受的平均治疗周期数为12，四分位数范围为25-75 [3.5-13.5]。所有患者在接受Cemiplimab治疗之前都接受了手术治疗，71.4％的患者接受了额外放疗治疗，只有1名患者在接受Cemiplimab之前接受了化疗治疗。其中一名患者出现了活检证实的急性肾移植物排斥反应，最终失去了移植物功能，但完全对肿瘤治疗作出了反应。其中一名患者出现了轻度皮肤毒性。这个病例系列表明，对于之前手术、化疗和/或放疗治疗无效的KTR晚期cSCC患者，使用Cemiplimab的ORR为42.8％，并且仅有很小的移植物排斥风险(14.3％)，且耐受性良好。版权所有© 2022年Van Meerhaeghe、Baurain、Bechter、Orte Cano、Del Marmol、Devresse、Doubel、Hanssens、Hellemans、Lienard、Rutten、Sprangers、Le Moine和Aspeslagh。

Kidney transplant recipients (KTR) are at increased risk of cancer due to chronic immunosuppression. Non-melanoma skin cancer has an excess risk of approximately 250 times higher than the general population. Moreover, in solid organ transplant recipients (SOTR) these cancers have a more aggressive behavior, with an increased risk of metastasis and death. Cemiplimab, a human monoclonal IgG4 antibody against programmed cell death (PD-1) has shown considerable clinical activity in metastatic and locally advanced cutaneous squamous cell carcinoma (cSCC) in patients for whom no widely accepted standard of care exists. Cemiplimab has therefore been approved since 2018 for the treatment of advanced cSCC. However, data regarding the use of cemiplimab in SOTR and particularly in KTR are scarce and based on published case reports and small case series. In this study, we report on the real-life outcome of cemiplimab use in a Belgian cohort of seven KTR suffering from advanced cSCC.To report on the overall response rate (ORR) and safety of cemiplimab in KTR in Belgium.Seven patients suffering from advanced cSCC, treated with cemiplimab, between 2018 and 2022, in Belgium were identified. Three patients were on corticosteroid monotherapy, one patient on tacrolimus monotherapy and three patients were on at least 2 immunosuppressants at start of cemiplimab. The ORR was 42.8%, stable disease was seen in 14.3% and progressive disease was found in 42.8% of the patients, respectively. The median administered number of cycles was 12, interquartile range (IQR) 25-75 [3.5 - 13.5]. All patients were treated with surgery before administration of cemiplimab, 71.4% received additional radiotherapy and only 1 patient was treated with chemotherapy prior to receiving cemiplimab. Biopsy-proven acute renal allograft rejection was observed in one patient, who eventually lost his graft function but showed a complete tumor response to treatment. Low grade skin toxicity was seen in one patient of the cohort.The present case series shows that the use of cemiplimab in KTR with advanced cSCC who failed to respond to previous surgery, chemo - and/or radiotherapy treatment is associated with an ORR of 42.8% with minimal risk of graft rejection (14.3%) and good tolerance.Copyright © 2022 Van Meerhaeghe, Baurain, Bechter, Orte Cano, Del Marmol, Devresse, Doubel, Hanssens, Hellemans, Lienard, Rutten, Sprangers, Le Moine and Aspeslagh.