■嵌合抗原受体T细胞(CAR-T)治疗,自2017年FDA批准以来,一种迅速出现的癌症治疗方法获得了势头,涉及对患者T细胞进行基因工程以靶向肿瘤。尽管已经观察到显著的治疗益处,已经报道了危及生命的不良肺部事件.
■使用SAS9.4和MedDRA26.1,我们回顾性分析了来自食品和药物管理局不良事件报告系统(FAERS)数据库的数据,涵盖2017年至2023年期间。分析包括报告赔率比比例报告比信息分量和经验贝叶斯几何平均值,以评估CAR-T细胞疗法与不良肺事件(PAEs)之间的关联。
■FAERS数据库记录了9,400起与CAR-T疗法有关的不良事件(AE),其中940(10%)为PAEs。在这些CAR-T细胞相关的AE中,缺氧是最常见的报道(344例),其次是呼吸衰竭(127例)。值得注意的是,不同的CAR-T细胞治疗与PAEs有不同程度的关联。具体来说,Tisa-cel与严重事件相关,包括呼吸衰竭和缺氧,而Axi-cel与缺氧和呼吸急促密切相关。此外,其他CAR-T疗法,即,Brexu-cel,Liso-cel,Ide-cel,还有Cilta-cel,也与不同的PAEs有关。值得注意的是,这些PAEs大部分发生在治疗后的前30天.不同CAR-T疗法的死亡率各不相同,Tisa-cel的死亡率最高(43.6%),其次是Ide-cel(18.8%)。
■这项研究全面分析了FAERS数据库中报告的CAR-T细胞疗法接受者的PAEs,揭示缺氧等条件,呼吸衰竭,胸腔积液,和肺不张。这些CAR-T细胞治疗相关事件具有临床意义,值得临床医生和研究人员关注。
UNASSIGNED: Chimeric antigen receptor T-cell (CAR-T) therapy, a rapidly emerging treatment for cancer that has gained momentum since its approval by the FDA in 2017, involves the genetic engineering of patients\' T cells to target tumors. Although significant therapeutic benefits have been observed, life-threatening adverse pulmonary events have been reported.
UNASSIGNED: Using SAS 9.4 with MedDRA 26.1, we retrospectively analyzed data from the Food and Drug Administration\'s Adverse Event Reporting System (FAERS) database, covering the period from 2017 to 2023. The analysis included the Reporting Odds Ratio Proportional Reporting Ratio Information Component and Empirical Bayes Geometric Mean to assess the association between CAR-T cell therapy and adverse pulmonary events (PAEs).
UNASSIGNED: The FAERS database recorded 9,400 adverse events (AEs) pertaining to CAR-T therapies, of which 940 (10%) were PAEs. Among these CAR-T cell-related AEs, hypoxia was the most frequently reported (344 cases), followed by respiratory failure (127 cases). Notably, different CAR-T cell treatments demonstrated varying degrees of association with PAEs. Specifically, Tisa-cel was associated with severe events including respiratory failure and hypoxia, whereas Axi-cel was strongly correlated with both hypoxia and tachypnea. Additionally, other CAR-T therapies, namely, Brexu-cel, Liso-cel, Ide-cel, and Cilta-cel, have also been linked to distinct PAEs. Notably, the majority of these PAEs occurred within the first 30 days post-treatment. The fatality rates varied among the different CAR-T therapies, with Tisa-cel exhibiting the highest fatality rate (43.6%), followed by Ide-cel (18.8%).
UNASSIGNED: This study comprehensively analyzed the PAEs reported in the FAERS database among recipients of CAR-T cell therapy, revealing conditions such as hypoxia, respiratory failure, pleural effusion, and atelectasis. These CAR-T cell therapy-associated events are clinically significant and merit the attention of clinicians and researchers.