[Chinese expert consensus on multigene testing for adjuvant treatment of HR-positive, HER-2 negative early breast cancer(2023 edition)].

Breast cancer is the most common malignant tumor in women, of which the majority is early breast cancer (EBC). The strategy of postoperative adjuvant treatment relies mainly on the clinicopathologic characteristics of patients, but there are certain deficiencies if only depending on it to assess treatment benefits and disease prognosis. Multigene testing tools can evaluate the prognosis and predict therapeutic effects of breast cancer patients to guide the clinical decision-making on whether to use adjuvant chemotherapy, radiotherapy, and endocrine therapy by detecting the expression levels of specific genes. The consensus-writing expert group, based on the characteristics, validation results, and accessibility of the multigene testing tools and combined with clinical practice, described the result interpretation and clinical application of OncotypeDx(®) (21-gene), Mammaprint(®) (70-gene), RecurIndex(®) (28-gene), EndoPredict(®)(12-gene), and BreastCancerIndex(®) (BCI, 7-gene) for hormone receptor-positive and human epidermal growth factor receptor 2-negative EBC. The development and validation process of each tool was also briefly introduced. It is expected that the consensus will help guide and standardize the clinical use of multigene testing tools and further improve the level of precise treatment for EBC.乳腺癌是女性最常见的恶性肿瘤，其中绝大多数为早期乳腺癌。乳腺癌术后辅助治疗决策的制定主要依据患者的临床病理特征，但仅依据于临床病理特征对于疗效及预后判断存在一定不足。多基因检测工具通过检测特定基因的表达水平，对不同患者的预后进行评估，并预测疗效，从而指导乳腺癌辅助化疗、放疗及内分泌治疗决策。共识专家组根据多基因检测工具的特点、验证结果及工具可及性，并结合临床实践，针对激素受体阳性、人表皮生长因子受体2阴性早期乳腺癌，将Oncotype Dx(®)(21基因)、Mammaprint(®)(70基因)、RecurIndex(®)(28基因)、EndoPredict(®)(12基因)以及Breast Cancer Index(®)(BCI，7基因)的结果判读及临床应用进行说明，并对各工具的开发和验证过程进行简要介绍。希望通过共识，能够有助于指导和规范多基因检测工具的临床运用，进一步提高早期乳腺癌的精准化治疗水平。.