在氧尿素不耐受性或氧尿素耐火性基本血栓细胞血症 (SURPASS ET) 中使用Ropeginterferon alfa-2b:多中心,开放标签,随机,主动控制的第三阶段研究
Ruben Mesa1, Harinder Gill2, Lei Zhang3
1Atrium Health, Wake Forest Baptist Comprehensive Cancer Center, Winston-Salem, NC, USA.
与阿纳格雷利德相比,罗佩干扰素α-2b显示出更高的疗效,作为二线治疗白血球性基本血栓塞病的二线治疗. 这种新疗法对不耐受或耐受氧尿素的患者提供了显著的改善.
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:
- 高风险基本血栓细胞血症 (ET) 的初始治疗是氧尿素,但耐药性或不耐受性影响了三分之一的患者.
- 阿纳格雷利德是ET的标准第二线治疗方法.
- 作为一种新的干扰素疗法,Ropeginterferon alfa-2b已被批准用于真实多细胞血症.
研究的目的:
- 为了评估rope-interferon alfa-2b与anagrelide的疗效和安全性.
- 评估rope-interferon alfa-2b作为二线治疗,用于患有白细胞病的基尿素不耐受或耐药ET患者.
主要方法:
- 第三阶段,开放标签,随机,主动控制的SURPASS ET试验.
- 174名患有高风险的ET,白细胞瘤和氧尿素不耐受/耐药性的患者被随机 (1:1) 分给rope-interferon alfa-2b或anagrelide.
- 主要终点:根据修改的欧洲白血病网 (ELN) 标准,在9个月和12个月的应答率.
主要成果:
- 该试验达到了其主要终点:43%的rope-interferon alfa-2b反应与6%的anagrelide相比 (p=0.0001).
- 与阿纳格利利德 (34%) 相比,3级以上的不良事件在rope-interferon alfa-2b (23%) 较少.
- 严重的不良事件也较低与rope-interferon alfa-2b (14%),而不是anagrelide (30%),没有脑梗塞事件.
结论:
- 在这个患者群体中,罗佩干扰素α-2b的疗效明显高于阿纳格利利德.
- 与阿纳格利利德相比,罗佩干扰素α-2b显示出一个有利的安全性概况.
- 罗佩干扰素α-2b是一种潜在的二线治疗选择,用于患有白细胞症的精性血栓塞瘤.
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