Murty Tara, Wai Karen M, Rahimy Ehsan, Mruthyunjaya Prithvi
Byers Eye Institute, Stanford University, Palo Alto, CA, USA.
Ocul Oncol Pathol. 2025 Jul;11(2):104-108. doi: 10.1159/000543055. Epub 2025 Jan 24.
INTRODUCTION: Chimeric antigen receptor (CAR)-T cell therapies have demonstrated remarkable therapeutic efficacy in leukemias and lymphomas that were previously considered incurable. However, concerns persist over potential risks related to toxicities, including those secondary to activation of the patient's immune system. METHODS: To investigate ocular adverse effects (o-AEs) associated with CAR-T cell therapy, a retrospective cohort study was designed in which data were obtained from the TriNetX aggregated electronic health records database through August 2024, with data analysis performed in August 2024. Billing codes were used to identify patients receiving autologous CAR-T therapy approved by the US Food and Drug Administration (FDA) for the treatment of a hematological malignancy: tisagenlecleucel, brexucabtagene autoleucel, lisocabtagene maraleucel, ciltacabtagene autoleucel, idecabtagene vicleucel, or axicabtagene ciloleucel. RESULTS: In a cohort of 684 patients on CAR-T therapy with at least 6 months of follow-up, the most prevalent o-AEs were related to vision changes (1.9%), which included vitreous opacities, visual disturbances, diplopia, and visual discomfort; inflammation (1.8%), which included optic neuritis, conjunctivitis, optic papillitis, chorioretinal inflammation, iridocyclitis, zoster ocular disease; and dry eyes (1.6%), which included dry eye syndrome, keratitis, and ocular manifestations of Vitamin A deficiency. CONCLUSION: In the period of 6 months following CAR-T therapy infusion, o-AEs were rare in patients receiving CAR-T cell therapy, indicating that patients without existing eye conditions do not need routine prescreening or directed follow-up after treatment, unless symptomatic. Ongoing monitoring and reporting of ocular adverse events will be important given the durable effects of CAR-T therapy in the treatment of hematologic cancers as well as increasing indications for CAR-T therapy in malignant and nonmalignant disease.
引言:嵌合抗原受体(CAR)-T细胞疗法已在先前被认为无法治愈的白血病和淋巴瘤中展现出显著的治疗效果。然而,对于包括患者免疫系统激活继发的毒性在内的潜在风险,人们依然忧心忡忡。 方法:为研究与CAR-T细胞疗法相关的眼部不良反应(o-AEs),设计了一项回顾性队列研究,通过TriNetX汇总电子健康记录数据库获取截至2024年8月的数据,并于2024年8月进行数据分析。使用计费代码识别接受美国食品药品监督管理局(FDA)批准用于治疗血液系统恶性肿瘤的自体CAR-T疗法的患者:替沙格韦单抗、布雷西尤单抗、利索卡韦单抗、西塔卡韦单抗、伊德卡韦单抗或阿西卡韦单抗。 结果:在684例接受CAR-T治疗且随访至少6个月的患者队列中,最常见的o-AEs与视力变化(1.9%)有关,包括玻璃体混浊、视觉障碍、复视和视觉不适;炎症(1.8%),包括视神经炎、结膜炎、视乳头炎、脉络膜视网膜炎、虹膜睫状体炎、眼部带状疱疹;以及干眼症(1.6%),包括干眼综合征、角膜炎和维生素A缺乏的眼部表现。 结论:在CAR-T治疗输注后的6个月内,接受CAR-T细胞治疗的患者中o-AEs很少见,这表明没有现有眼部疾病的患者在治疗后不需要常规预筛查或定向随访,除非出现症状。鉴于CAR-T疗法在血液系统癌症治疗中的持久效果以及CAR-T疗法在恶性和非恶性疾病中的适应证不断增加,持续监测和报告眼部不良事件将很重要。
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