在复发性或耐火性地幔细胞淋巴瘤中使用ibrutinib的现实结果:一项基于丹麦人口的研究
Trine Trab1,2, Iman Chanchiri3,4, Ahmed Ludvigsen Al-Mashhadi5
1Department of Hematology, Rigshospitalet, Copenhagen, Denmark.
Blood neoplasia
|August 14, 2025
概括
与临床试验相比,对复发/耐药的地幔细胞淋巴瘤 (MCL) 实践中使用易布鲁替尼的有效性和常见不良事件较低,表明需要更好的治疗方法.
科学领域:
- 血液学 血液学 血液学
- 在瘤学瘤学.
- 临床药理学 临床药理学
背景情况:
- 易布鲁替尼被批准用于复发性/耐药性 (R/R) 的地幔细胞淋巴瘤 (MCL).
- 在R/R MCL中,ibrutinib的实际有效性和预后因素尚未得到充分确立.
研究的目的:
- 评估在R/R MCL患者中对ibrutinib的真实反应率,生存率,预后指标和不良事件 (AE).
- 将现实世界的结果与临床试验的结果进行比较.
主要方法:
- 在丹麦 (2010-2022) 接受ibrutinib治疗的146名R/R MCL患者的基于人口的回顾性研究.
- 从健康记录中收集的数据,分析整体反应率 (ORR),无进展生存率 (PFS),整体生存率 (OS) 和AE.
- 考克斯回归用于确定PFS的预后因素.
主要成果:
- 总体应答率 (ORR) 为56%,中位数PFS为5.8个月,中位数OS为12.0个月.
- 与劣质PFS相关的因素包括高Ki67,布拉斯/形亚型,早期复发和耐火性疾病.
- 副作用导致19%的患者在三年内停止治疗,22%的患者减少剂量.
结论:
- 在R/RMCL中,IBRUTINIB的实际结果不如临床试验结果.
- 高水平的剂量限制性毒性和较差的生存率强调了需要改进治疗策略和剂量优化.
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