The clinician’s perspective on the 21-gene assay in early breast cancer

Francesco Cognetti _ and Giuseppe Naso

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Oncotarget. 2021; 12:2514-2530. https://doi.org/10.18632/oncotarget.28148

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Francesco Cognetti1 and Giuseppe Naso1

1 Department of Clinical and Molecular Medicine, University La Sapienza, Rome, Italy

Correspondence to:

Francesco Cognetti, email: [email protected]

Keywords: Oncotype DX test; recurrence score results; multigene assays; genomic tests; personalized medicine

Received: September 11, 2021     Accepted: November 10, 2021     Published: December 21, 2021

Copyright: © 2021 Cognetti and Naso. This is an open access article distributed under the terms of the Creative Commons Attribution License (CC BY 3.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.


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.

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