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:

  • Precisely identify those patients who will derive benefit from chemotherapy
  • Define 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 early HR+, HER2- 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 outcome5–10

The Oncotype DX test is the only test validated to identify patients likely to benefit from chemotherapy, or not.5–8

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

*ClinicalTrials.gov identifier: NCT01272037, fully recruited

Development of the Oncotype DX Test

The Oncotype DX test was developed to assess disease prognosis and quantify the benefit from chemotherapy (CT) in patients with early-stage, HR+, HER2- breast cancer. Genes were selected accordingly, and the test’s predictive abilities were validated based on two-arm retrospective prospective clinical trial (comparing CT+ Endocrine Therapy (ET) versus ET alone): the NSABP B-20 (for node-negative patients) and SWOG-8814 trial (for node-positive patients). Recently, the landmark TAILORx study showed that ET was non-inferior to CT + ET in patients with node-negative disease and midrange Recurrence Score results. This supports earlier research indicating that the majority of patients do not benefit from the addition of chemotherapy.

The Oncotype DX test was developed to predict chemotherapy benefit based on a unique understanding of tumour biology. 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.9 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.9 Based on the expression levels of the 21 genes, a Recurrence Score result is calculated for each tumour sample.9

The Oncotype DX test reveals individual tumour biology based on measuring the expression of 21 genes5,6,8-10,13

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 group average chemotherapy benefit.

Learn more about interpreting the results of the Oncotype DX test for node-negative and node-positive patients.

The Oncotype DX test for node-negative patients

In node-negative, early-stage, HR+, HER2- breast cancer patients, studies including > 85,000 patients have established that the Oncotype DX test consistently identifies the vast majority of patients (80%) who can be spared chemotherapy and the important minority (20%) who will substantially benefit from it.5,6,9,13–15,19 This includes the largest ever prospective, randomised adjuvant clinical trial in breast cancer: the landmark TAILORx study, which enrolled more than 10,000 patients.6,18

Patient selection using the Oncotype DX test in node-negative patients

a 80% of the patients proven not to benefit from chemotherapy, whereas for 20% of them, it might be life-saving6,13-16,19-21

Learn more about reducing the risk of over- and undertreatment in node-negative patients and in node-positive patients.

The Oncotype DX test for node-positive patients

The test’s predictive ability in the node positive setting was validated in the two-arm prospective retrospective clinical trial SWOG-8814 (comparing CT+ Endocrine Therapy (ET) versus ET alone)8. Results from this trial are summarized in the graphic below. Patients with one to three positive lymph nodes and Recurrence Score results 0-17 are consistently shown to have excellent outcomes when treated with ET alone8,10,12,14,16. Real-world observations22 suggest that 60% of HR+, HER2- patients with one to three positive nodes tested with Oncotype DX have a Recurrence Score result 0-17 and hence could be spared chemotherapy.

Patient Selection using the Oncotype DX test in node-positive patients8

of node-positive patients tested outside of clinical trials22 have a Recurrence Score result 0-17 and may be overtreated without testing

AI, aromatase Inhibitor
CT, chemotherapy
ET, endocrine therapy
HER2–, human epidermal growth factor receptor 2 negative
HR+, hormone receptor positive
N+, node-positive
N0, node-negative
TAM, Tamoxifen

  1. Partridge et al. J Natl Cancer Inst Monogr. 2001.
  2. Friese et al. Cancer. 2017.
  3. Groenvold. Dan Med Bull. 2010.
  4. EBCTCG. Lancet. 2012.
  5. Paik et al. J Clin Oncol. 2006.
  6. Sparano JA et al. N Engl J Med. 2018.
  7. Ballman et al. J Clin Oncol. 2015.
  8. Albain et al. Lancet Oncol. 2010.
  9. Paik et al. N Engl J Med. 2004.
  10. Dowsett M et al. J Clin Oncol. 2010.
  11. RxPONDER, NCT01272037.
  12. Nitz et al. Breast Cancer Res Treat. 2017.
  13. Geyer et al. NPJ Breast Cancer. 2018.
  14. Hortobagyi et al. SABCS 2018.
  15. Stemmer et al. St. Gallen Conference. 2019.
  16. Stemmer et al. NPJ Breast Cancer. 2017.
  17. Mamounas et al. NPJ Breast Cancer. 2018.
  18. Sparano et al. N Engl J Med. 2019.
  19. Sparano et al. N Engl J Med. 2015.
  20. Petkov et al. Npj Breast Cancer. 2016.
  21. Blohmer et al. ESMO 2017.
  22. Bello et al. Ann Surg Onc. 2018.
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