用于治疗AML不适合强化化疗的患者的阿斯帕西塔拉宾:一项2期研究
Jessica K Altman1, Tsila Zuckerman2, Jamie Koprivnikar3
1Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago, IL.
Blood advances
|October 30, 2023
概括
阿斯帕西塔拉宾是一种新型前药物,对急性髓性白血病 (AML) 患者不适合进行密集化疗具有前性. 这项研究发现,与高剂量cytarabine相比,它的毒性降低了.
科学领域:
- 血液学 血液学 血液学
- 在瘤学瘤学.
- 药理学 药理学是指药理学的学科.
背景情况:
- 在老年/不适合的急性髓性白血病 (AML) 患者中,由于胃肠道和小脑的毒性,高剂量的cytarabine (Ara-C) 是有限的.
- 阿斯帕基塔拉宾是一种不活跃的细胞胺原药,提供了一种潜在的替代品,具有潜在的改善安全性.
研究的目的:
- 评估阿斯帕西塔拉宾作为单一治疗的有效性和安全性,用于AML患者,这些患者不适合接受密集化疗.
- 评估完全缓解 (CR) 率,整体存活率和与阿斯帕西塔拉宾治疗相关的不良事件.
主要方法:
- 一项2b期研究 (NCT03435848) 招募了65名不适合的AML患者.
- 患者每天接受阿斯帕西塔拉宾4.5g/m2为6次剂量,相当于每天3g/m2的阿斯帕西塔拉宾.
- 结果包括CR,CR完全复苏,整体存活率和不良事件.
主要成果:
- 36.9%的患者实现了完全缓解 (CR),数量完全恢复.
- 平均整体存活时间为9个月;响应者没有达到.
- 在所有响应者中,在26日内观察到血液的恢复,没有长期的细胞衰竭.
- 与高剂量的cytarabine相关的关键毒性没有观察到.
结论:
- 阿斯帕西塔拉宾在不适合的AML患者中表现出有效性,达到与标准疗法相比的CR率.
- 降低的毒性概况表明,阿斯帕西塔拉宾可能是AML患者不适合高剂量细胞塔拉宾的有价值选择.
- 需要对AML和其他血液恶性瘤中的阿斯巴基塔拉宾进行进一步的研究.
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