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在RET突变阳性甲状腺髓癌中使用selpercatinib的单臂LIBRETTO-001试验的真实外部控制臂:RECALIB-RET

J Hadoux¹, J Hernando², K H Wong³

¹Service d'Oncologie Endocrinienne, Département d'Imagerie, Gustave Roussy, Université Paris Saclay, Villejuif, France; ENDOCAN-TUTHYREF Network, France.

|March 4, 2026

概括

与标准护理相比,塞尔珀卡丁尼布显著改善了治疗前未经治疗的患者的无进展生存率,这些患者在转移过程中重新安排了 (RET) 突变阳性髓状甲状腺癌. 晚期治疗线的结果是不确定的.

科学领域:

在瘤学瘤学.
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:

在LIBRETTO-001试验中,selpercatinib在转移期间重新安排 (RET) - 突变阳性髓状甲状腺癌 (MTC) 的疗效被证明.
在RECALIB-RET研究中,selpercatinib与标准护理 (SoC) 进行了比较,使用了对RET突变阳性MTC的真实外部控制 (EC) 臂.

研究的目的:

为了比较selpercatinib与SoC在RET突变阳性MTC患者中的有效性.
为了评估治疗手臂之间的无进展生存 (PFS) 和安全概况.

主要方法:

追溯分析比较selpercatinib (来自LIBRETTO-001) 与EC手臂 (汇总现实世界的数据).
倾向性得分匹配 (PSM) 用于平衡基线特征.
主要终点是无进展生存期 (PFS);安全性是次要终点.

主要成果:

在一线 (1L) 治疗中,selpercatinib在PSM前后都显示出比SoC具有统计学意义的PFS益处.
在第二线和后一线 (≥2L) 治疗中,未调整的PFS中位数在塞尔珀卡提尼布治疗中较长,但由于消耗,PSM后的区别并不显著.
对SoC的安全调查结果与之前的报告一致.

结论:

塞尔珀卡丁尼布在第一线RET突变阳性MTC中比SoC提供了显著的PFS优势.
较后的治疗线路中的比较有效性需要进一步研究.
将现实数据与前性试验相匹配是对比疗效研究的一个可行的方法.

关键词:

利布雷托-001 的意思在RET突变中.骨髓甲状腺癌是一种甲状腺癌.多酶抑制剂的使用在现实世界中,外部控制臂是真实的.塞尔珀卡提尼布 (selpercatinib) 是一种可以

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