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Updated: Jun 13, 2025

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在BRAF突变结直肠癌中使用恩科拉费尼布,塞图西马布和化疗:一个随机的第三期试验

Scott Kopetz¹, Takayuki Yoshino², Eric Van Cutsem³

¹University of Texas MD Anderson Cancer Center, Houston, TX, USA. SKopetz@mdanderson.org.

Nature medicine

|January 25, 2025

概括

一线Encorafenib + cetuximab (EC) 显著改善了BRAF V600E突变转移性结直肠癌 (mCRC) 患者的客观反应率. 这种组合疗法为这种患者群体提供了更有效的治疗选择.

科学领域:

在瘤学瘤学.
临床试验临床试验
胃肠道癌症胃肠道癌症

背景情况:

从历史上看,BRAF V600E突变转移性结直肠癌 (mCRC) 的治疗选择有限.
此前对这种mCRC亚型的治疗方法的疗效有限.
恩科拉费尼布+塞图西马布 (EC) 已被批准用于先前治疗的BRAF V600E突变mCRC.

研究的目的:

为了研究一线Encorafenib + cetuximab加mFOLFOX6的疗效和安全性,与以前未经治疗的BRAF V600E突变mCRC.患者的标准护理 (SOC) 相比.
评估无进展生存率和客观反应率的双重初级终点.

主要方法:

第三阶段,随机化,开放标签研究 (BREAKWATER).
以前未经治疗的BRAF V600E突变mCRC患者接受了EC + mFOLFOX6或SOC.
评估了客观反应率 (ORR) 和整体存活率 (OS).

主要成果:

与SOC (40.0%) 相比,EC + mFOLFOX6手臂的ORR显著更高 (60.9%).
在EC + mFOLFOX6手臂中,响应的中位持续时间更长 (13.9个月与11.1个月).
对OS的临时分析显示,EC + mFOLFOX6 (危险比率0.47) 的趋势有利.

结论:

以恩科拉费尼布+塞图西马布加mFOLFOX6的第一线治疗显示,BRAF V600E突变mCRC.患者的客观应答率显著而持久地改善.
EC + mFOLFOX6的安全性概况与单个药物的已知安全性概况一致.
水研究支持EC + mFOLFOX6作为BRAF V600E突变mCRC.第一线治疗的新护理标准.

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