What is the Oncotype DX^® test, and what makes it unique?

The Oncotype DX Breast Recurrence Score^® test has been developed for patients with early-stage HR+, HER2- breast cancer to:

• Identify those patients who may benefit from chemotherapy^1,2
• Determine the magnitude of chemotherapy benefit^1-5
• Support treatment decisions^1-5

Chemotherapy can cause both short- and long-term side effects affecting current and future health, quality of life, family life and work life.^6-8 The vast majority of patients with HR+, HER2- early-stage breast cancer do not benefit from adjuvant chemotherapy.⁹

The Oncotype DX test is the only multigene assay that is both predictive of chemotherapy treatment effect and prognostic of disease outcome^1-5,10-14

The Oncotype DX test is the only test clinically validated to identify patients likely to benefit from chemotherapy, or not.^1-5,10-14

Learn more about the difference between prognostic and predictive tests

Prediction of chemotherapy benefit based on prospective clinical trials makes the Oncotype DX test unique

Development of the Oncotype DX Test

The Oncotype DX test was developed to assess disease prognosis and predict benefit from chemotherapy (CT) in patients with early-stage, HR+, HER2- breast cancer.¹⁰ Genes were selected accordingly, and the test’s predictive abilities were validated in two-arm retrospective prospective clinical trials (comparing CT+ Endocrine Therapy (ET) versus ET alone): the NSABP B-20 for node-negative patients^1,13 and SWOG-8814 for node-positive patients.² The test was then further validated in two prospective studies. The landmark TAILORx study showed that ET was non-inferior to CT + ET in patients with node-negative disease and Recurrence Score results 11 to 25.^2,16 In addition, RxPONDER study initial results demonstrated that postmenopausal patients with Recurrence Score results 0-25 do not benefit from chemotherapy, independent of clinical pathologic parameters.^4,5 The results of the practice-changing TAILORx and RxPONDER studies supports earlier research indicating that the majority of patients do not benefit from the addition of chemotherapy.^3,4,5,9

The Oncotype DX test was developed to predict chemotherapy benefit based on a unique understanding of tumour biology.^1,10 The Oncotype DX test quantifies expression of 21 genes, 16 cancer-related and five reference genes.¹⁰ Based on the expression levels of the 21 genes, a Recurrence Score result is calculated for each tumour sample.¹⁰

The Oncotype DX test reveals individual tumour biology based on measuring the expression of 21 genes^1,10

What information does the Oncotype DX test provide?

The Oncotype DX test identifies patients who may benefit from adjuvant chemotherapy, or not, by providing three pieces of information: the Recurrence Score result, the risk of distant recurrence, and the estimated chemotherapy benefit.^1-5,10-11,13

Learn more about the Oncotype DX test for: