在一项跨国现实世界研究中,glofitamab对复发/耐火性大B细胞淋巴瘤的安全性和有效性
Evgenii Shumilov1, Rebecca Wurm-Kuczera2, Andrea Kerkhoff3
1University Hospital Münster, Muenster, Germany.
Blood advances
|December 11, 2024
概括
格洛菲他马布在复发性/耐药性扩散性大B细胞淋巴瘤 (r/rDLBCL) 中显示出有希望的现实世界疗效. 建议谨慎使用之前的T细胞消耗剂,如达穆斯丁,因为它可能对结果产生影响.
科学领域:
- 血液学 血液学 血液学
- 在瘤学瘤学.
- 免疫治疗是一种免疫疗法.
背景情况:
- 双特异性CD20/CD3抗体Glofitamab已被批准用于复发性/耐火性扩散性大B细胞淋巴瘤 (r/rDLBCL).
- 在重度预治疗的患者中,关于glofitamab疗效和安全性的现实数据有限.
研究的目的:
- 评估glofitamab治疗在患有r/rDLBCL的患者中的实际结果.
- 评估与glofitamab治疗相关的安全性,包括细胞因子释放综合征 (CRS) 和神经毒性.
- 在这个患者群体中确定对glofitamab的反应和耐药性的预测因子.
主要方法:
- 这是一项回顾性,多中心,跨国研究,涉及70名患有r/r DLBCL的患者,这些患者在同情使用计划下接受了glofitamab治疗.
- 收集关于患者人口统计,先前治疗,安全事件 (CRS,ICANS,感染) 和疗效结果 (反应率,PFS,OS) 的数据.
- 对预后因素的分析,包括LDH升高和先前暴露于bendamustine.
主要成果:
- 总体反应率 (ORR) 为47% (27%的完整反应,20%的部分反应).
- 无进展生存时间 (PFS) 中位数为3.6个月,总生存时间 (OS) 中位数为5.7个月.
- 常见的不良事件包括CRS (40%),ICANS (10%) 和感染 (31%);3-4级事件很少发生.
- 之前在6个月内接受的bendamustine治疗与PFS显著减少有关,这表明它可能对T细胞健康有影响.
结论:
- 在现实环境中,glofitamab在重度预治疗的r/r DLBCL患者中显示出有希望的疗效和可管理的安全性.
- 在一小部分实现完全缓解的患者中观察到持久的反应.
- 在开始使用glofitamab之前,需要谨慎对待T细胞消耗剂的测序,例如bendamustine.
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