CHRONOS-4:Copanlisib加上基于rituximab的免疫化学疗法在复发性沉默性B细胞淋巴瘤中的第三阶段研究
Pier Luigi Zinzani1,2, Huaqing Wang3, Jifeng Feng4
1IRCCS Azienda Ospedaliero-Universitaria di Bologna, Istituto di Ematologia "Seràgnoli," Bologna, Italy.
Blood advances
|July 26, 2024
概括
科潘利西布与利图西马布和本达穆斯结合并没有改善复发性无病性非霍奇金淋巴瘤的无进展生存率. 组合治疗的疗效与安慰剂相似,但增加了严重的不良事件和停止治疗.
科学领域:
- 在瘤学瘤学.
- 药理学 药理学是指药理学的学科.
背景情况:
- 酸氨基醇3基因酶抑制剂Copanlisib,此前曾显示出在惰性非霍奇金淋巴瘤 (iNHL) 的承诺.
- 之前的研究表明,当与Rituximab结合使用时,Copanlisib单独治疗和改善无进展生存率 (PFS) 会产生持久的反应.
研究的目的:
- 评估利西布加标准免疫化学疗法的疗效和安全性,用于复发性iNHL的患者.
- 在3期试验中,比较Copanlisib加Rituximab和Bendamustine (R-B) 与安慰剂加R-B.
主要方法:
- CHRONOS-4是一项3期,随机,双盲,安慰剂控制的研究.
- 524名患有复发iNHL的患者被随机分配给接受copanlisib (60mgIV) 加R-B或安慰剂加R-B.
- 治疗涉及R-B长达6个周期,随后单一治疗长达12个月;PFS是主要终点.
主要成果:
- 科潘利西布加R-B的PFS中位数为32.9个月,而安慰剂加R-B的PFS中位数为33.3个月 (HR,1.13;P=.83).
- 没有观察到总体存活率,客观响应率或响应持续时间在手臂之间存在显著差异.
- 利西布加R-B与较高的严重治疗出现不良事件 (TEAE) 相关,包括感染,4/5级TEAE和停止治疗.
结论:
- 与安慰剂加R-B相比,Copanlisib加R-B在复发iNHL的患者中没有显示出临床益处.
- 组合治疗与更差的耐受性和严重不良事件的增加有关.
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