The Oncotype DX Test Results: What to expect

All breast cancers are not the same and the chances of surviving treatment are improving all the time. As our understanding of breast cancer increases, it has become possible to tailor specific treatment plans to better suit the needs of each patient. The Oncotype DX Breast Recurrence Score® test plays an important role in creating confidence and reassurance in the treatment decision you and your doctor will make.

The Oncotype DX Recurrence Score® test is performed on cancer tissue obtained from a biopsy procedure or during initial surgery to remove primary cancer from the breast.1,2 No additional surgery is required.

Approximately 10 working days after your tumour sample arrives at the Exact Sciences laboratory, a written report will be sent to your doctor electronically via a secure password protected online account. The results provide a score between 0 and 100 that indicates how likely your cancer is to return and predicts how beneficial adding chemotherapy is likely to be for you to further reduce the risk of your cancer returning.3-6

Understanding Your Recurrence Score Result

The lower the Recurrence Score result is (between 0-25), the less likely you are to benefit from chemotherapy; the higher the Recurrence Score result is (considered 26 and above), the more likely you are to benefit from chemotherapy. A high score means that chemotherapy in addition to standard hormone therapy could reduce your risk of your cancer returning. (Please see the section below on Personalising Treatment).

As the benefits of chemotherapy treatment are much less certain in women with HR+/ER+ (hormone / oestrogen receptor-positive) and HER2-negative (human epidermal growth factor receptor 2-negative) early-stage, invasive breast cancers the Recurrence Score result helps to address the key question of whether or not you will need to add chemotherapy to your treatment plan in order to minimise the risk of your cancer returning.

It is important to understand that a lower Recurrence Score result does not mean that there is no chance the cancer will return. Similarly, a higher result does not mean that chemotherapy will definitely prevent the cancer from returning. A balance must be weighed between the benefits of chemotherapy and its inevitable side effects. Your treatment decision depends on your unique situation from a clinical perspective and your personal preferences in discussion with your doctor.

Because your Recurrence Score result is based on your specific cancer it helps your doctor understand the underlying biology of your cancer, so your treatment plan can be tailored specifically for you.


Why the Oncotype DX test?


As the most commonly used genomic test in the UK for invasive breast cancer, Oncotype DX is the only test proven to determine the expected benefit from chemotherapy in early-stage breast cancer. Several studies have consistently proven that the test can predict which patients will benefit from chemotherapy, or not.3-6
The test has also been validated for its ability to assess the risk of a patient’s cancer returning (recurrence), with or without chemotherapy. The ability of the test to predict the likely benefit of chemotherapy makes the Oncotype DX test unique.

Personalising Treatment

The Oncotype DX Test has now been tested in over 1 million patients worldwide. It is recommended by the UK’s National Institute for Health and Care Excellence (NICE)7 and is incorporated in all major internationally accepted clinical practice guidelines for breast cancer treatment.8-11

The results of two large, independent clinical studies (TAILORx5 and RxPONDER6) in more than 15,000 patients support previous trials for the Oncotype DX test. The TAILORx study confirmed that chemotherapy does not reduce the risk of the cancer returning in early-stage, node-negative breast cancer patients (~80%) patients with Recurrence Score results of 0 to 25 and node negative women 50 and younger derived a modest benefit from chemotherapy starting with a Recurrence Score result of 16. Furthermore, in RxPONDER study showed that postmenopausal patients with node positive (1-3 nodes positive) breast cancer and Recurrence Score result 0-25 did not benefit from chemotherapy, and thus could also forego chemotherapy without compromising outcomes. On the other hand, premenopausal patients with node positive breast cancer and a Recurrence Score result 0-25 did benefit from chemotherapy.

For women with Recurrence Score results 26 to 100 regardless of age, previous data have shown that there is a clear and large chemotherapy benefit.12-13

Whatever your result or age, it is very important to discuss your Recurrence Score result with your healthcare professional. This important additional information will help you and your doctor make a personalised treatment plan with more precision and confidence.13

Find out more about eligibility and testing.

REFERENCES
  1. Anderson et al. SABCS 2009.
  2. Stull et al. SABCS 2011.
  3. Paik et al. N Engl J Med. 2006.
  4. Albain et al. Lancet Oncol. 2010.
  5. Kalinsky et al. SABCS 2020 Abstract GS3-00.
  6. NCCN Guidelines Insights: Breast Cancer, version 3.2021 https://www.nccn.org/professionals/physician_gls/pdf/breast.pdf (accessed Nov. 2021). All rights reserved. Subject to Notice of rights NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.
  7. NICE Diagnostics Guidance DG34 December 2018. https://www.nice.org.uk/ (accessed Nov. 2021).
  8. Burstein et al. Ann Oncol. 2021.
  9. Andre et al. J Clin Oncol. 2019.
  10. Cardoso et al. Ann Oncol. 2019.
  11. Sparano et al. N Engl J Med. 2018.
  12. Geyer et al. NPJ Breast Cancer. 2018.
  13. Sparano et al. N Engl J Med. 2019.
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