Tomsitz Dirk, Ruf Theresa, Zierold Sarah, French Lars E, Heinzerling Lucie
Department of Dermatology and Allergy, University Hospital, LMU Munich, 80539 Munich, Germany.
SERIO Side Effects Registry Immunooncology, 80337 Munich, Germany.
Cancers (Basel). 2023 Apr 28;15(9):2538. doi: 10.3390/cancers15092538.
The occurrence, second-line management and outcome of sr/sd-irAEs was investigated in patients with skin cancer. All skin cancer patients treated with immune checkpoint inhibitors (ICIs) between 2013 and 2021 at a tertiary care center were analyzed retrospectively. Adverse events were coded by CTCAE version 5.0. The course and frequency of irAEs were summarized using descriptive statistics. A total of 406 patients were included in the study. In 44.6% (n = 181) of patients, 229 irAEs were documented. Out of those, 146 irAEs (63.8%) were treated with systemic steroids. Sr-irAEs and sd-irAEs (n = 25) were detected in 10.9% of all irAEs, and in 6.2% of ICI-treated patients. In this cohort, infliximab (48%) and mycophenolate mofetil (28%) were most often administered as second-line immunosuppressants. The type of irAE was the most important factor associated with the choice of second-line immunosuppression. The Sd/sr-irAEs resolved in 60% of cases, had permanent sequelae in 28% of cases, and required third-line therapy in 12%. None of the irAEs were fatal. Although these side effects manifest in only 6.2% of patients under ICI therapy, they impose difficult therapy decisions, especially since there are few data to determine the optimal second-line immunosuppression.
对皮肤癌患者中严重/重度免疫相关不良反应(irAEs)的发生情况、二线治疗及结局进行了调查。对2013年至2021年在一家三级医疗中心接受免疫检查点抑制剂(ICIs)治疗的所有皮肤癌患者进行了回顾性分析。不良事件按照美国国立癌症研究所不良事件通用术语标准第5.0版(CTCAE version 5.0)进行编码。使用描述性统计方法总结irAEs的病程和发生频率。共有406例患者纳入研究。44.6%(n = 181)的患者记录有229起irAEs。其中,146起irAEs(63.8%)接受了全身性激素治疗。在所有irAEs中,10.9%检测到严重irAEs和重度irAEs(n = 25),在接受ICIs治疗的患者中占6.2%。在该队列中,英夫利昔单抗(48%)和霉酚酸酯(28%)最常作为二线免疫抑制剂使用。irAE的类型是与二线免疫抑制选择相关的最重要因素。60%的严重/重度irAEs病例得到缓解,28%的病例有永久性后遗症,12%的病例需要三线治疗。所有irAEs均无致命情况。尽管这些副作用仅在6.2%接受ICI治疗的患者中出现,但它们带来了艰难的治疗决策,尤其是因为确定最佳二线免疫抑制的可用数据很少。