JACC:肿瘤治疗里程碑——注意万能CAR-T疗法的心肺不良事件!

2021-10-28 MedSci原创 MedSci原创

嵌合抗原受体T细胞(CAR-T细胞)的诞生是人类与肿瘤的斗争中具有里程碑意义的事件。

嵌合抗原受体T细胞(CAR-T细胞)的诞生是人类与肿瘤的斗争中具有里程碑意义的事件。从首个人工改造TCR嵌合T细胞的出现并验证其有特异性抗原识别活性,到嵌合入特异性抗体单链可变区(scFv)片段和共刺激分子区域的CAR-T细胞成为主流,再到CAR-T细胞被临床公认为一种安全、有效、持续杀伤肿瘤细胞的免疫细胞疗法,其过程复杂又艰辛。

越来越多有关CAR-T的关键试验已经确定了常见的毒性,但在检测血管和肺部不良事件(CPAEs)方面可能数据仍不足。为了调查与商业CD19导向的CAR-T疗法相关的CPAEs,来自以色列Chaim Sheba医疗中心Leviev心脏中心的专家开展了相关研究,结果发表在JACC杂志上。

在这项回顾性的药物警戒研究中,作者使用食品和药物管理局的不良事件报告系统来确定与axicabtagen-ciloleucel(简称AC)和tisagenlecleucel(简称TG)有关的CPAEs。作者通过报告几率(ROR)和信息成分95%可信区间的下限(IC025>0被认为是显著的)评估了不相称的报告。有意义的关联被进一步调整为年龄和性别(adj.ROR)。

最终确定了2657名患者的CAR-T报告,包括546例CPAEs(20.5%)。在68.3%的报告中,CPAEs与细胞因子释放综合征相重叠(546例中的373例)。与完整的数据库相比,CAR-T与过度报告心动过速(n = 74 [2.8%], adj.ROR = 2.78 [95% CI: 2.21-3.51])、心肌病(n = 69 [2. 6%], adj.ROR = 3.51 [2.42-5.09]),胸膜疾病(n = 46 [1.7%], adj.ROR = 3.91 [2.92-5.23])和心包疾病(n = 11 [0.4%], adj.ROR = 2.26 [1.25-4.09],所有IC025 >0)的风险增加有关。

所有CAT-T疗法、AC疗法、TG疗法的不良心肺事件汇总

同时,静脉血栓栓塞事件(VTEs)仅与AC治疗有关(n = 28 [1.6%], adj.ROR = 1.80 [1.24-2.62], IC025>0)。心房颤动(n = 55)是主要的快速性心律失常,其次是室性心律失常(n = 14)。在经过年龄和性别调整的模型中,AC治疗后,心动过速和VTE的报道比TG更多(adj.ROR=1.82[1.04-3.18]和adj.ROR=2.86[1.18-6.93],分别)。最后,CPAEs的死亡率为30.9%。

综上,该研究发现CAR-T与包括心动过速、心肌病、心包和胸膜病变以及VTEs等在内的心肺不良事件相关。

 

参考文献:

Adverse Cardiovascular and Pulmonary Events Associated With Chimeric Antigen Receptor T-Cell Therapy. J Am Coll Cardiol. 2021 Nov, 78 (18) 1800–1813

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    2022-03-07 xzw113
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    2022-04-04 仁者大医
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    2022-02-08 hbwxf
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    2022-09-12 aids222
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    2021-10-29 汪汪王要加油

    学到了

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