Abstract
Oncotype DX® is a multigene assay that provides prognostic information in terms of 10-year distant recurrence and predicts the likelihood of adjuvant chemotherapy benefit in estrogen receptor positive breast cancer patients, based on the expression of a panel of 21 genes (16 cancer-related and five reference genes) from a tumor specimen (core biopsy or surgical resection). It has been validated using multiple prospectively designed studies of archived tumor specimens from well-controlled clinical studies. In different countries with varying therapeutic approaches, using Oncotype DX has consistently resulted in a significant reduction in the number of patients who are prescribed chemotherapy, and in addition, it can identify a smaller subset of patients who would benefit from chemotherapy among patients who would otherwise receive endocrine therapy alone.
Financial & competing interests disclosure
The author has received speaker’s honoraria and educational grants from AstraZeneca (UK), Novartis (Basel, Switzerland), Pfizer Inc. (New York, NY, USA) and Genomic Health Inc. (USA). The author is solely responsible for the content of the manuscript with no restrictions set by Genomic Health Inc. The author has no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.
Writing support for the development of the manuscript was provided by Ossian Health Economics and Communications, Basel, Switzerland, through an unrestricted educational grant from Genomic Health Inc.