PDF(Pubmed)
Abstract：
Although the immunotherapy advent has revolutionized cancer treatment, it, unfortunately, does not spare cancer patients from possible immune-related adverse events (irAEs), which can also involve the peripheral nervous system. Immune checkpoint inhibitors (ICIs), blocking cytotoxic T-lymphocyteassociated protein 4 (CTLA-4), programmed cell death protein 1 (PD-1), or programmed cell death ligand 1 (PD-L1), can induce an immune imbalance and cause different peripheral neuropathies (PNs). Considering the wide range of PNs and their high impact on the safety and quality of life for cancer patients and the availability of large post-marketing surveillance databases, we chose to analyze the characteristics of ICI-related PNs reported as suspected drug reactions from 2010 to 2020 in the European real-world context. We analyzed data collected in the European pharmacovigilance database, Eudravigilance, and conducted a systematic and disproportionality analysis. In our study, we found 735 reports describing 766 PNs occurred in patients treated with ICIs. These PNs included Guillain-Barré syndrome, Miller-Fisher syndrome, neuritis, and chronic inflammatory demyelinating polyradiculoneuropathy. These ADRs were often serious, resulting in patient disability or hospitalization. Moreover, our disproportionality analysis revealed an increased reporting frequency of PNs with tezolizumab compared to other ICIs. Guillain-Barré syndrome is a notable potential PN related to ICIs, as it is associated with a significant impact on patient safety and has had unfavorable outcomes, including a fatal one. Continued monitoring of the safety profile of ICIs in real-life settings is necessary, especially considering the increased frequency of PNs associated with atezolizumab compared with other ICIs.
摘要：
尽管免疫疗法的出现彻底改变了癌症治疗，it,不幸的是,不能使癌症患者免于可能的免疫相关不良事件（irAE），也可能涉及周围神经系统。免疫检查点抑制剂（ICIs），阻断细胞毒性T淋巴细胞相关蛋白4（CTLA-4），程序性细胞死亡蛋白1（PD-1），或程序性细胞死亡配体1（PD-L1），可以诱导免疫失衡并引起不同的周围神经病(PNs)。考虑到广泛的PN及其对癌症患者的安全性和生活质量的高度影响，以及大型上市后监测数据库的可用性，我们选择在欧洲现实背景下分析2010-2020年报告为可疑药物反应的ICI相关PN的特征.我们分析了欧洲药物警戒数据库中收集的数据，Eudra警惕，并进行了系统和不相称性分析。在我们的研究中,我们发现735份报告描述了在接受ICIs治疗的患者中发生的766例PNs.这些PNs包括格林-巴利综合征，Miller-Fisher综合征,神经炎,和慢性炎性脱髓鞘性多发性神经根神经病。这些ADR通常很严重，导致患者残疾或住院。此外，我们的不成比例分析显示,与其他ICI相比,使用替唑珠单抗的PNs报告频率增加.格林-巴利综合征是一种与ICIs相关的显著潜在PN，因为它与对患者安全的重大影响相关，并且有不利的结果，包括一个致命的。有必要在现实生活中继续监测ICI的安全状况，特别是考虑到与阿司珠单抗相关的PNs频率与其他ICI相比增加.
