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埃尔特罗姆博帕格与或没有Tacrolimus复发/耐药性获得的无性贫血:一个潜在的随机试验

Jiang Ji¹, Ziqi Wan¹, Jing Ruan¹

¹Peking Union Medical College Hospital (PUMCH), Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.

Blood cancer journal

|September 19, 2023

概括

与单独使用埃尔特罗姆博帕格相比,埃尔特罗姆博帕格加上塔克罗利斯在获得的无形性贫血患者中显示出更好的反应率,特别是在60岁以下的患者中. 在不同治疗方法之间,存活率和安全性概况相似.

科学领域:

血液学血液学血液学
临床试验临床试验
药理学药理学是指药理学的学科.

背景情况:

获得的无塑性贫血 (AA) 是一种罕见的,严重的骨髓衰竭疾病.
耐药性/复发性AA存在重大治疗挑战.
埃尔特伦博巴格 (EPAG) 和塔克罗利斯在AA治疗中使用,但组合疗效需要进一步研究.

研究的目的:

为了比较ELTROMBOPAG (EPAG) 与TACROLIMUS结合的疗效和安全性,与EPAG单一治疗在患有耐火性/复发性获得性无塑性贫血 (AA) 的患者.
为了评估整体反应率 (ORR),生存率,安全性和克隆进化.
确定可能从组合治疗中受益的潜在子组.

主要方法:

一个随机试验比较EPAG+tacrolimus (n=76) 与EPAG单疗法 (n=38) 在不耐药/复发的AA患者中.
随访时间中位数为18个月.
3,6,12个月的ORR评估和最后的随访;安全性,整体存活率和克隆进化也受到监测.

主要成果:

虽然ORR在3个月是相似的 (38.2%对31.6%),但EPAG+tacrolimus在6个月 (61.8%对39.5%,P=0.024) 和最后的随访 (60.5%对34.2%,P=0.008) 显示ORR显著更高.
在不良事件,整体存活率 (P=0.635) 或克隆进化 (P=1.000) 中没有发现显著差异.
亚组分析表明,EPAG+tacrolimus在6个月和最后一次随访后改善了ORR,以及60岁以下患者的累积无复发存活率.

结论:

与ELTROMBOPAG和TACROLIMUS联合治疗显示,与ELTROMBOPAG单独治疗相比,在不耐药/复发性获得性无塑性贫血中反应率更高.
组合疗法似乎是安全的,不会对存活率或克隆进化产生负面影响.
较年轻的患者 (<60岁) 可能特别受益于将塔克罗利莫斯添加到ELTROMBOPAG治疗中.

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