Van Meerhaeghe T, Baurain J F, Bechter O, Orte Cano C, Del Marmol V, Devresse A, Doubel P, Hanssens M, Hellemans R, Lienard D, Rutten A, Sprangers B, Le Moine A, Aspeslagh S
Department of Nephrology, Hôpital Erasme - Université Libre de Bruxelles (ULB), Brussels, Belgium.
Department of Oncology, Clinique Universitaire Saint-Luc - Université Catholique de Louvain (UCLouvain), Brussels, Belgium.
Front Nephrol. 2022 Oct 31;2:1041819. doi: 10.3389/fneph.2022.1041819. eCollection 2022.
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.
由于长期免疫抑制，肾移植受者（KTR）患癌症的风险增加。非黑色素瘤皮肤癌的患病风险比普通人群高出约250倍。此外，在实体器官移植受者（SOTR）中，这些癌症的侵袭性更强，转移和死亡风险增加。西米普利单抗是一种抗程序性细胞死亡（PD-1）的人源单克隆IgG4抗体，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，而这些患者尚无广泛认可的标准治疗方案。因此，自2018年以来，西米普利单抗已被批准用于治疗晚期cSCC。然而，关于西米普利单抗在SOTR尤其是KTR中的应用数据稀少，仅基于已发表的病例报告和小病例系列。在本研究中，我们报告了比利时一组7例患有晚期cSCC的KTR使用西米普利单抗的实际疗效。
报告比利时KTR中使用西米普利单抗的总体缓解率（ORR）和安全性。
确定了2018年至2022年期间在比利时接受西米普利单抗治疗的7例晚期cSCC患者。3例患者接受皮质类固醇单药治疗，1例患者接受他克莫司单药治疗，3例患者在开始使用西米普利单抗时至少接受2种免疫抑制剂治疗。患者的ORR为42.8%，疾病稳定率为14.3%，疾病进展率为42.8%。给药周期的中位数为12，四分位间距（IQR）25 - 75 [3.5 - 13.5]。所有患者在使用西米普利单抗之前均接受了手术治疗，71.4%的患者接受了额外的放疗，只有1例患者在接受西米普利单抗之前接受了化疗。1例患者出现活检证实的急性肾移植排斥反应，该患者最终失去移植肾功能，但对治疗显示出完全的肿瘤反应。该队列中有1例患者出现轻度皮肤毒性。
本病例系列表明，在对先前手术、化疗和/或放疗治疗无反应的晚期cSCC的KTR中使用西米普利单抗，ORR为42.8%，移植排斥风险最低（14.3%），耐受性良好。
