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弗鲁昆丁尼布在较少预先治疗的患者中:对FRESCO-2对FRESCO的多变量配置匹配分析

Arvind Dasari¹, Cathy Eng², Sara Lonardi³

¹Department of Gastrointestinal Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.

European journal of cancer (Oxford, England : 1990)

|August 12, 2025

概括

果丁尼布在转移性结直肠癌患者中显示出显著的整体生存益处. 在全球较少预先治疗的人群中,疗效是一致的,没有显示出新的安全问题.

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FRESCO和FRESCO-2研究的第三阶段,果丁尼布显著改善了转移性结直肠癌 (mCRC) 患者的整体存活率 (OS).
这些研究包括了具有不同先前治疗方法的多样群体;FRESCO患者的预治疗比FRESCO-2患者少.
这项分析评估了与FRESCO-2治疗意向 (ITT) 人群相比,在全球较少预先治疗的人群中评估fruquintinib的疗效和安全性.

研究的目的:

评估fruquintinib在全球不太预先治疗的转移性结直肠癌患者群体中的疗效和安全性.
在与FRESCO-2患者和FRESCO ITT患者群体匹配的子集中比较fruquintinib治疗的结果.

主要方法:

患者被随机分为2:1接受口服弗鲁昆丁尼布 (5毫克) 或安慰剂,以及最佳支持性护理.
使用包括年龄,表现状态,RAS状态,转移部位,肝转移和先前治疗线路在内的变量进行了个人资料匹配.
评估了整体存活率 (OS),无进展存活率 (PFS) 和安全性.

主要成果:

152名FRESCO-2患者与FRESCO ITT群体进行了匹配,表现出类似的基线特征和预治疗概况.
对OS的危险比率为0.63 (FRESCO-2子集),0.62 (FRESCO ITT) 和0.63 (组合);对于PFS的危险比率分别为0.34,0.27和0.30.
治疗出现的3级以上的不良事件发生在63.7% (FRESCO-2子组),61.2% (FRESCO ITT) 和61.8% (组合) 的接受fruquintinib.com的患者中.

结论:

弗鲁昆丁尼布在全球mCRC群体中表现出具有临床意义的疗效,其先前治疗暴露率低于FRESCO-2 ITT群体.
无论之前的治疗线路如何,fruquintinib的疗效都保持不变.
没有发现新的安全信号,支持fruquintinib的安全性.

关键词:

结肠直肠癌是一种癌症.弗雷斯科 (Fresco) 是一个艺术品.弗雷斯科-2是Fresco-2的第二个版本.弗鲁昆丁尼布的使用方法转移性结直肠癌是什么意思多变量分析多变量分析.个人资料匹配匹配.这是一种VEGFR抑制剂.

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