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Review
. 2025 Apr:135:102887.
doi: 10.1016/j.ctrv.2025.102887. Epub 2025 Jan 16.

Current controversies in the use of Oncotype DX in early breast cancer

Pier Paolo M Berton Giachetti  1 , Ambra Carnevale Schianca  1 , Dario Trapani  1 , Antonio Marra  2 , Angela Toss  3 , Caterina Marchiò  4 , Maria Vittoria Dieci  5 , Oreste Davide Gentilini  6 , Carmen Criscitiello  1 , Kevin Kalinsky  7 , Joseph A Sparano  8 , Giuseppe Curigliano  9
Affiliations
Review

Current controversies in the use of Oncotype DX in early breast cancer

Pier Paolo M Berton Giachetti et al. Cancer Treat Rev. 2025 Apr.

Abstract

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.

Keywords: Adjuvant chemotherapy; Breast cancer; Oncotype DX; RxPONDER; TAILORx.

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Conflict of interest statement

Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: AM has received honoraria as a consultant, advisor or speaker from Roche, Eli Lilly and Menarini/Stemline; has received travel and accommodation support from AstraZeneca, and is supported by the ESMO José Baselga Fellowship for Clinician Scientists sponsored by AstraZeneca 2023–2025. AT reports a consulting/advisory role for Lilly, Novartis, Pfizer, MSD, Astrazeneca, Daiichi Sankyo, Exact Science, Menarini Stemline, Gilead. CM has received personal consultancy fees from Roche, Menarini, Illumina, AstraZeneca and Daiichi Sankyo. MVD reports personal fees from Genomic Health, Eli Lilly, Celgene, and Novartis. OR reported receiving personal fees from AstraZeneca, Bayer, BD, Eli Lilly and Company, and MSD. ODG has received honoraria as consultant, advisor or speaker from MSD, Astra Zeneca, Eli-Lilly, BD, Bayer. CC reports personal fees for consulting, advisory role and speakers’ bureau from Eli Lilly, Roche, Novartis, MSD, Seagen, Gilead and Pfizer. KK has disclosed advisory/consulting funding from Eli-Lilly, Pfizer, Novartis, Eisai, AstraZeneca, Immunomedics, Merck, Seattle Genetics, OncoSec, 4D Pharma, Daiichi Sankyo, and Cyclocel. Dr. Kalinsky also reports financial disclosures for his spouse (stock): Grail, Array BioPharma and Pfizer (prior employee). JAS reports a consulting/advisory role for Genentech/Roche, Novartis, AstraZeneca, Celgene, Lilly, Celldex, Pfizer, Prescient Therapeutics, Juno Therapeutics, Merrimack, Adgero Biopharmaceuticals, Cardinal Health, GlaxoSmithKline, CStone Pharmaceuticals, Epic Sciences, Daiichi Sankyo, BMSi. GC reports financial interests with AstraZeneca, Daiichi Sankyo, Exact Sciences, Lilly, Merck, Novartis, Pfizer, Roche, Veracyte, Ellipsis, Astellas, Blueprint Medicine, BMS, Merck, Novartis, Menarini, Relay Therapeutics, Sanofi; and non-financial interests with the Italian National Health Council as Advisor for Ministry of Health, ESMO as Clinical Practice Guidelines Chair, Europa Donna as Member of the Scientific Council, EUSOMA as member of the Advisory Council, Fondazione Beretta. All the competing interests were outside the submitted work. All other authors have no potential conflicts of interest to disclose. This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.

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