Most invasive breast cancers express hormone receptors (HR) and typically have a favorable prognosis following endocrine therapy. Patients at a higher risk of recurrence can be identified by multigene prognostic classifiers such as the 21‐gene recurrence score (RS) assay, 70‐gene prognostic signature, PAM‐50, 12‐gene molecular score, and others. The 21‐gene RS assay (Oncotype Dx™, Genomic Health, Redwood City, CA) has level I clinical evidence and is the most widely used multigene assay in North America. The RS assay is based on reverse transcriptase polymerase chain reaction that can be performed on the RNA isolated from formalin‐fixed paraffin‐embedded tissue. It evaluates the expression of 16 cancer‐related genes developed based on a multi‐step approach. Due to its ability to assess recurrence risk and predict potential benefit from chemotherapy, the assay is recommended for patients with node‐negative, HR‐positive, and human epidermal growth factor receptor 2 (HER2)‐negative breast cancer by the American Society of Clinical Oncology, National Comprehensive Cancer Network clinical practice guidelines in oncology, European Society for Medical Oncology clinical practice guidelines, and St. Gallen consensus panel guidelines. The RS assay has also been incorporated in the prognostic stage groups in the 8th edition of the American Joint Commission of Cancer staging manual in order to provide essential genomic information for optimal treatment decisions. This review will focus on the utility of the RS assay in HR‐positive and HER2‐negative breast cancer patients, including risk of distant and locoregional recurrence in node‐negative and node‐positive tumors, association with radiotherapy, special subtypes of breast cancer, practical issues related to selecting tumors for testing, and overview of the recently published TailorX (Trial Assigning IndividuaLized Options for treatment [Rx]) results.

中文翻译：

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乳腺癌中的多基因检测：我们从21基因复发评分分析中学到了什么？

大多数浸润性乳腺癌会表达激素受体（HR），在内分泌治疗后通常具有良好的预后。可以通过多基因预后分类器（例如21基因复发评分（RS）分析，70基因预后签名，PAM-50、12基因分子评分等）来识别复发风险较高的患者。21基因RS检测（Oncotype Dx™，基因组健康，加利福尼亚州红木市）具有I级临床证据，是北美使用最广泛的多基因检测方法。RS分析基于逆转录酶聚合酶链反应，该反应可对从福尔马林固定石蜡包埋的组织中分离的RNA进行。它评估了基于多步骤方法开发的16种癌症相关基因的表达。由于其具有评估复发风险和预测化疗潜在获益的能力，因此该方法推荐用于美国临床学会推荐的淋巴结阴性，HR阳性和人表皮生长因子受体2（HER2）阴性的乳腺癌患者肿瘤学，国家肿瘤综合癌症网络临床实践指南，欧洲医学肿瘤学会临床实践指南和圣加仑共识小组指南。RS分析也已纳入《美国癌症联合委员会分期手册》第8版的预后阶段组中，以便为最佳治疗决策提供必要的基因组信息。本文将重点探讨RS分析在HR阳性和HER2阴性乳腺癌患者中的实用性，