Cognetti Francesco, Naso Giuseppe
Department of Clinical and Molecular Medicine, University La Sapienza, Rome, Italy.
Oncotarget. 2021 Dec 21;12(26):2514-2530. doi: 10.18632/oncotarget.28148.
Most patients with early HR+ and HER2- breast cancer receive a hormone therapy; the clinical question still open is how to identify patients who can really benefit from adjuvant chemotherapy. The accurate identification of these patients is essential to avoid an over-treatment, increasing the risk of an unnecessary toxicity; on the contrary, the omission of chemotherapy can deprive high risk patients of a potential life-saving treatment (under-treatment). Several multigene assays (MGAs), assessing the risk of relapse according to the biological characteristics of the tumor, have been developed. To date, the 21-gene assay (Oncotype DX Breast Recurrence Score) is the only test developed and validated to be actionable, i.e., able to predict the benefit of adjuvant chemotherapy. The different available tests can be classified according to their clinical utility based on their prognostic and predictive value. A prognostic test gives information about the outcome of the disease, regardless of the administered therapy. When the aim of the test is to drive the treatment decisions, the predictive component, and therefore the ability to accurately identify which patients could benefit from chemotherapy, is essential. This review summarizes the clinical evidences of the Oncotype DX test supporting its clinical utility.
大多数早期激素受体阳性（HR+）且人表皮生长因子受体2阴性（HER2-）的乳腺癌患者会接受激素治疗；目前仍未解决的临床问题是如何识别真正能从辅助化疗中获益的患者。准确识别这些患者对于避免过度治疗、降低不必要毒性风险至关重要；相反，遗漏化疗可能会使高危患者失去潜在的挽救生命的治疗（治疗不足）。已经开发了几种多基因检测方法（MGAs），根据肿瘤的生物学特征评估复发风险。迄今为止，21基因检测（Oncotype DX乳腺癌复发评分）是唯一一种已开发并验证可用于指导治疗的检测方法，即能够预测辅助化疗的获益情况。根据不同检测方法的预后和预测价值，可将现有的不同检测方法按照临床实用性进行分类。预后检测可提供有关疾病结局的信息，而不考虑所给予的治疗。当检测目的是指导治疗决策时，预测成分，即准确识别哪些患者可从化疗中获益的能力，至关重要。本综述总结了支持Oncotype DX检测临床实用性的临床证据。
