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Healthcare Professionals > Oncotype DX Breast Recurrence Score

What is the Oncotype DX® test?

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

  • Identify those patients who will derive benefit from chemotherapy
  • Determine the magnitude of chemotherapy benefit
  • Make chemotherapy a personalised treatment

Chemotherapy causes both short- and long-term side effects affecting current and future health, quality of life, family life and work life.1-3 The vast majority of patients with HR+, HER2- early-stage breast cancer do not benefit from adjuvant chemotherapy.4

The Oncotype DX test is the only multigene assay that is both predictive of chemotherapy treatment effect and prognostic of disease outcome5-13

The Oncotype DX test is the only test clinically validated to identify patients likely to benefit from chemotherapy, or not.5-13

Learn more about the difference between prognostic and predictive tests

See the difference

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

*TAILORx showed that endocrine therapy was non-inferior to chemoendocrine therapy in node-negative patients with Recurrence Score® results 11-25. RxPONDER showed that node-positive postmenopausal patients with Recurrence Score® results 0-25 do not benefit from chemotherapy while premenopausal patients with 1 to 3 positive nodes and RS® results 0-25 have a modest benefit from chemotherapy.

Development of the Oncotype DX Test

The Oncotype DX test was developed to assess disease prognosis and predicts benefit from chemotherapy (CT) in patients with early-stage, HR+, HER2- breast cancer9. 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 patients5,13 and SWOG-8814 for node-positive patients8. The landmark TAILORx study6 showed that ET was non-inferior to CT + ET in patients with node-negative disease and Recurrence Score results 11 to 25. In addition, RxPONDER study11 initial results demonstrated that postmenopausal patients with Recurrence Score results 0-25 can be spared chemotherapy independent of clinical pathologic parameters. This supports earlier research indicating that the majority of patients do not benefit from the addition of chemotherapy.4

The Oncotype DX test was developed to predict chemotherapy benefit based on a unique understanding of tumour biology5,9. The Oncotype DX test quantifies expression of 21 genes in fixed, paraffin-embedded tumour tissue using high-throughput, real-time, reverse transcription-polymerase chain reaction. Three independent breast cancer studies were used to select the panel of 16 cancer-related and five reference genes that are tested in the Oncotype DX assay. Based on the expression levels of the 21 genes, a Recurrence Score result is calculated for each tumour sample.

The Oncotype DX test reveals individual tumour biology based on measuring the expression of 21 genes9

16 Cancer Genes and 5 Reference Genes


What information does the Oncotype DX test provide?

The Oncotype DX test identifies patients who will 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.



Guiding treatment with the Oncotype DX test

In summary, thanks to the comprehensive clinical evidence for both node-negative and node-positive patients, the Oncotype DX test can help guide confident chemotherapy treatment decisions.

CT benefit expressed in percentage points based on probability of distant recurrence (N0) or distant recurrence-free interval (N1) with/without CT;
No CT benefit is considered for an absolute benefit <1%;
Node-negative (N0) patients: TAILORx analyses were performed by age and demonstrated patients ≤ 50 years derived some clinically meaningful benefit from CT at 9 years starting with an RS® result of 16;
Node-positive (N1) patients: RxPONDER data were analysed according to menopausal status and demonstrated that premenopausal patients with RS® results 0-25 overall derived benefit from chemotherapy at 5 years.
* Benefit of chemotherapy for premenopausal N1 patients with RS® results 26-100 has not been formally assessed in a randomised study. The benefit derived from chemotherapy was modest for RS results 0-13 and 14-25 in the RxPONDER study and it is inferred to be substantial for patients with RS result 26-100.

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