Berton Giachetti Pier Paolo M, Carnevale Schianca Ambra, Trapani Dario, Marra Antonio, Toss Angela, Marchiò Caterina, Dieci Maria Vittoria, Gentilini Oreste Davide, Criscitiello Carmen, Kalinsky Kevin, Sparano Joseph A, Curigliano Giuseppe
Division of New Drugs and Early Drug Development for Innovative Therapies European Institute of Oncology IRCCS Milano Italy; Department of Oncology and Hemato-Oncology University of Milano Milano Italy.
Division of New Drugs and Early Drug Development for Innovative Therapies European Institute of Oncology IRCCS Milano Italy.
Cancer Treat Rev. 2025 Apr;135:102887. doi: 10.1016/j.ctrv.2025.102887. Epub 2025 Jan 16.
Multigene prognostic genomic assays have become essential tools in the management of early breast cancer (BC), providing information that help in risk-stratification, to provide risk-adapted decision-making of adjuvant treatments. Clinical practice guidelines recommend refining the prognostic information provided by clinical and pathology features with the use of genomic tests, such as Oncotype DX®, to classify cancers into risk groups and inform adjuvant treatment strategies. However, the clinical value (i.e., prognostic and/or predictive) and applicability of these assays vary due to differences in the clinical setting, especially in those populations that were underrepresented in pivotal clinical trials. Oncotype DX® is a broadly utilized genomic test for breast cancer, having the highest level of supporting evidence to inform clinical practice. Our manuscript provides a comprehensive overview on this recurrence score assay, evaluates supporting evidence across patient populations, and discusses their impact on treatment decisions in those groups of patients underrepresented in pivotal clinical trials, where evidence is limited with the use of Oncotype DX.
多基因预后基因组检测已成为早期乳腺癌（BC）管理中的重要工具，提供有助于风险分层的信息，以便为辅助治疗提供风险适应性决策。临床实践指南建议使用基因组检测（如Oncotype DX®）来完善临床和病理特征提供的预后信息，将癌症分类为风险组并为辅助治疗策略提供依据。然而，由于临床环境的差异，尤其是在关键临床试验中代表性不足的人群中，这些检测的临床价值（即预后和/或预测价值）及适用性各不相同。Oncotype DX®是一种广泛应用于乳腺癌的基因组检测，具有为临床实践提供信息的最高水平的支持证据。我们的手稿全面概述了这种复发评分检测，评估了不同患者群体的支持证据，并讨论了其对关键临床试验中代表性不足的患者群体治疗决策的影响，在这些群体中，使用Oncotype DX的证据有限。
