对于未经治疗的急性髓性白血病,Glasdegib加强化或非强化化疗法:随机选择的3期BRIGHT AML 1019试验的结果
Mikkael A Sekeres1, Pau Montesinos2,3, Jan Novak4,5
1Division of Hematology, Sylvester Comprehensive Cancer Center, University of Miami, Miami, FL, USA. msekeres@med.miami.edu.
Leukemia
|August 21, 2023
概括
在与强化或非强化化疗法相结合时,glasdegib在急性髓性白血病患者中没有改善整体存活率. 布莱特AML 1019试验没有达到其主要疗效终点.
科学领域:
- 血液学 血液学 血液学
- 在瘤学瘤学.
- 临床试验 临床试验
背景情况:
- 急性髓性白血病 (AML) 是一种异质的血液性恶性瘤.
- 针对AML的标准治疗包括密集化疗 (cytarabine和daunorubicin) 和非密集化疗 (azacitidine).
- 格拉斯迪吉 (Glasdegib) 是一种针对性疗法,研究用于AML治疗.
研究的目的:
- 评估glasdegib与密集性或非密集性化疗结合在未经治疗的急性髓性白血病患者中的疗效和安全性.
- 为了确定glasdegib是否与安慰剂相比改善整体存活率.
主要方法:
- 一个随机的,安慰剂控制的,第三期临床试验 (BRIGHT AML 1019).
- 患者接受了glasdegib或安慰剂,并结合了cytarabine和daunorubicin (强化疗法) 或azacitidine (非强化化疗法).
- 总体存活率是主要的终点.
主要成果:
- 在密集化疗组 (HR 1.05) 和非密集化疗组 (HR 0.99) 中,glasdegib和安慰剂组的整体存活率相似.
- 在glasdegib和安慰剂组之间,治疗出现的不良事件是可比的.
- 常见的不良事件包括恶心,发烧性中性质和贫血.
结论:
- 在密集或非密集化疗中添加glasdegib并没有显著改善未经治疗的急性髓性白血病的整体存活率.
- 布赖特AML 1019 3期试验没有达到其主要疗效终点.
- 格拉斯德吉布联合治疗显示了与安慰剂相似的安全性.
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