在复发或耐火性大B细胞淋巴瘤中,在Axicabtagene Ciloleucel之后的托西利祖马布预防
Frederick L Locke1, Sattva S Neelapu2, Nancy L Bartlett3
1Moffitt Cancer Center, Tampa, Florida.
Transplantation and cellular therapy
|August 26, 2024
概括
在Axicabtagene ciloleucel治疗的大型B细胞淋巴瘤患者中,预防性托西利祖马布并没有预防细胞因子释放综合征或神经事件. 升高的IL-6水平与严重的神经事件相关,这表明托西利祖马布不建议用于预防.
科学领域:
- 在瘤学瘤学.
- 免疫治疗是一种免疫疗法.
- 临床试验 临床试验
背景情况:
- 艾克西卡巴丁基可乐塞尔 (axi-cel) 是一种有效的CAR T细胞疗法,用于复发性/耐药性大B细胞淋巴瘤 (LBCL).
- 细胞因子释放综合征 (CRS) 和神经事件 (NE) 是与轴细胞治疗相关的常见毒性.
- ZUMA-1试验调查了安全扩展队列,以减轻这些毒性.
研究的目的:
- 评估预防性托西利祖马布和 levetiracetam 在预防接受R/R LBCL axi-cel治疗的患者中CRS和NE的疗效.
- 在这个安全扩展队列中评估axi-cel的安全性和有效性.
主要方法:
- 祖马-1队列3招募了接受轴细胞治疗的R/R LBCL患者.
- 预防性托西利祖马布在轴细胞输液后48小时内被给予.
- 主要终点包括CRS和NE的发病率和严重程度;次要终点包括反应率和存活率.
主要成果:
- 任何级别的CRS (92%) 和NE (87%) 是常见的;观察到等级≥3的CRS (3%) 和NE (42%).
- 发生了一次5级NE (大脑水).
- 客观反应率为63%,平均整体存活期为34.8个月;CAR T细胞扩张率与关键队列相当.
结论:
- 预防性托西利祖马布不建议用于预防与CAR T细胞相关的不良事件,原因是缺乏疗效和可能增加IL-6水平.
- 升高的IL-6水平与等级≥3的NE相关,这表明神经毒性的作用.
- 预防性 levetiracetam 的益处仍然不确定.
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