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Tissue-agnostic drug approvals: how does this apply to patients with breast cancer?
npj Breast Cancer ( IF 5.9 ) Pub Date : 2021-09-13 , DOI: 10.1038/s41523-021-00328-3
Luiza N Weis 1 , Sara M Tolaney 2, 3 , Carlos H Barrios 4 , Romualdo Barroso-Sousa 1, 5
Affiliation  

Precision medicine has provided new perspectives in oncology, yielding research on the use of targeted therapies across different tumor types, regardless of their site of origin, a concept known as tissue-agnostic indication. Since 2017, the Food and Drug Administration (FDA) has approved the use of three different agents for tumor-agnostic treatment: pembrolizumab (for patients with microsatellite instability or high tumor mutational burden) and larotrectinib and entrectinib (both for use in patients harboring tumors with NTRK fusions). Importantly, the genomic alterations targeted by these agents are uncommon or rare in breast cancer, and little information exists regarding their efficacy in advanced breast cancer. In this review, we discuss the prevalence of these targets in breast cancer, their detection methods, the clinical characteristics of patients whose tumors have these alterations, and available data regarding the efficacy of these agents in breast cancer.



中文翻译:

与组织无关的药物批准:这如何适用于乳腺癌患者?

精准医学为肿瘤学提供了新的视角,产生了针对不同肿瘤类型(无论其起源部位如何)使用靶向治疗的研究,这一概念被称为组织不可知适应症。自 2017 年以来,美国食品和药物管理局 (FDA) 已批准使用三种不同的药物进行与肿瘤无关的治疗:pembrolizumab(用于微卫星不稳定或高肿瘤突变负荷的患者)以及 larotrectinib 和 entrectinib(均用于携带肿瘤的患者)与NTRK融合)。重要的是,这些药物针对的基因组改变在乳腺癌中并不常见或罕见,而且关于它们在晚期乳腺癌中的疗效的信息很少。在这篇综述中,我们讨论了这些靶点在乳腺癌中的流行程度、它们的检测方法、肿瘤具有这些改变的患者的临床特征,以及有关这些药物在乳腺癌中疗效的可用数据。

更新日期:2021-09-13
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