乳腺癌临床决策的分子和蛋白质标志物:今天和明天。

Molecular and protein markers for clinical decision making in breast cancer: today and tomorrow.

机构信息

Brustzentrum, Universitätsfrauenklinik, Klinikum Großhadern, Marchioninistr. 15, München, Germany.

Pathologisches Institut, Ludwig-Maximilians-Universität München, Thalkirchner Strasse. 36, München, Germany.

出版信息

Cancer Treat Rev. 2014 Apr;40(3):434-44. doi: 10.1016/j.ctrv.2013.09.014. Epub 2013 Sep 29.

Abstract

In early breast cancer (eBC), established clinicopathological factors are not sufficient for clinical decision making particularly regarding adjuvant chemotherapy since substantial over- or undertreatment may occur. Thus, novel protein- and molecular markers have been put forward as decision aids. Since these potential prognosis and/or predictive tests differ substantially regarding their methodology, analytical and clinical validation, this review attempts to summarize the essential facts for clinicians. This review focuses on those markers which are the most advanced so far in their development towards routine clinical application, i.e. two protein markers (i.e. uPA/PAI-1 and IHC4) and six molecular multigene tests (i.e. Mammaprint®, Oncotype DX®, PAM50, Endopredict®, the 97-gene genomic grade, and 76 gene Rotterdam signatures). Next to methodological aspects, we summarized the clinical evidences, in particular the main prospective clinical trials which have already been fully recruited (i.e. MINDACT, TAILORx, WSG PLAN B) or are still ongoing (i.e. RxPONDER/SWOG S1007, WSG-ADAPT). Last but not least, this review points out the key elements for clinicians to select one test among the wide panel of proposed assays, for a specific population of patients in term of level of evidence, analytical and clinical validity as well as cost effectiveness.

摘要

在早期乳腺癌 (eBC) 中,既定的临床病理因素不足以用于临床决策,尤其是在辅助化疗方面,因为可能会出现过度治疗或治疗不足的情况。因此,已经提出了新的蛋白质和分子标记物作为决策辅助工具。由于这些潜在的预后和/或预测性测试在方法学、分析和临床验证方面存在很大差异,因此本篇综述尝试总结这些对临床医生有用的基本事实。

本篇综述主要关注那些在常规临床应用方面发展最先进的标记物,即两种蛋白质标记物(即 uPA/PAI-1 和 IHC4)和六种分子多基因测试(即 Mammaprint®、Oncotype DX®、PAM50、Endopredict®、97 基因基因组分级和 76 基因鹿特丹标记物)。除了方法学方面,我们还总结了这些临床证据,特别是已经完全招募的主要前瞻性临床试验(即 MINDACT、TAILORx、WSG PLAN B)或仍在进行中的临床试验(即 RxPONDER/SWOG S1007、WSG-ADAPT)。最后但同样重要的是,本篇综述指出了临床医生在广泛的建议检测方案中选择一个测试的关键要素,这需要考虑到特定患者群体的证据水平、分析和临床有效性以及成本效益。

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