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Spotlight on the utility of the Oncotype DX® breast cancer assay

Authors Siow ZR, De Boer RH, Lindeman GJ, Mann GB

Received 14 September 2017

Accepted for publication 6 December 2017

Published 21 February 2018 Volume 2018:10 Pages 89—100

DOI https://doi.org/10.2147/IJWH.S124520

Checked for plagiarism Yes

Review by Single-blind

Peer reviewers approved by Dr Amy Norman

Peer reviewer comments 2

Editor who approved publication: Professor Everett Magann


Zhen Rong Siow,1–3 Richard H De Boer,2,3 Geoffrey J Lindeman,1–4 G Bruce Mann2–4

1ACRF Stem Cells and Cancer Division, Walter and Eliza Hall Institute of Medical Research, 2Department of Medical Oncology, Peter MacCallum Cancer Centre, 3Familial Cancer Centre, The Royal Melbourne Hospital, 4Faculty of Medicine, Dentistry and Health Sciences, The University of Melbourne, Parkville, VIC, Australia

Abstract: The Oncotype DX® assay was developed to address the need for optimizing the selection of adjuvant systemic therapy for patients with estrogen receptor (ER)-positive, lymph node-negative breast cancer. It has ushered in the era of genomic-based personalized cancer care for ER-positive primary breast cancer and is now widely utilized in various parts of the world. Together with several other genomic assays, Oncotype DX has been incorporated into clinical practice guidelines on biomarker use to guide treatment decisions. The Oncotype DX result is presented as the recurrence score which is a continuous score that predicts the risk of distant disease recurrence. The assay, which provides information on clinicopathological factors, has been validated for use in the prognostication and prediction of degree of adjuvant chemotherapy benefit in both lymph node-positive and lymph node-negative early breast cancers. Clinical studies have consistently shown that the Oncotype DX has a significant impact on decision making in adjuvant therapy recommendations and appears to be cost-effective in diverse health care settings. In this article, we provide an overview of the validation and clinical impact studies for the Oncotype DX assay. We also discuss its potential use in the neoadjuvant setting, as well as the more recent prospective validation trials, and the economic and utility implications of studies that use a lower cutoff score to define low-risk disease.

Keywords: breast cancer, adjuvant, Oncotype DX®, recurrence score, utility

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