The Oncotype® DX Breast Recurrence Score
Oncotype Dx® is a genomic lab test that helps guide treatment choices for people with early-stage invasive breast cancers. This test helps decide if using chemotherapy along with hormone (endocrine) therapy after surgery will lower your risk of your cancer coming back (recurring).
Genomic tests are not the same as genetic tests. Genetic tests look for a single-gene mutation (change) in your body (like BRCA 1 and 2). Genomic tests look at the genes in your tumor to help guide your treatment options.
Organizations like the National Comprehensive Cancer Network (NCCN) and the American Society of Clinical Oncology (ASCO) recommend using this test. Other tests may be used, but you will want to make sure that they are validated by major cancer organizations.
Who should get this test?
Oncotype DX® testing is used if you meet these criteria:
- You have invasive breast cancer. It is used in women with invasive breast cancer but is being studied in men with breast cancer.
- The stage of your cancer is I, II, or IIIA. Your lymph nodes can be negative or you can have 1-3 positive nodes.
- Your cancer is ER+ (estrogen receptor-positive) and HER2 negative. This means your cancer is likely to respond to hormone therapy
How does the test work?
After you have surgery (lumpectomy or mastectomy), pieces of the tumor are sent to an Exact Sciences Laboratory (a specific lab for cancer related tests) where the test is done. It takes about 2 weeks for your provider to get the results.
Scientists look at the tumor samples. They measure the amount of 21 specific genes in the tumor tissue. Sixteen of the genes are cancer-related; the other 5 are used as "reference" genes. Based on the amount of each of these genes, a score is given. This is called the Recurrence Score (RS). This score is on a scale of 0-100. Higher scores mean there is a greater risk of recurrence (cancer coming back). A higher score also means that getting chemotherapy would likely reduce the risk of your cancer coming back. Your recurrence score, along with your age and the size and grade of your tumor, will be used to pick the best treatment for you to help prevent a recurrence.
What does the recurrence score mean?
How the score is used to guide your treatment depends on your menopausal status (if you still menstruate or not) and if you have cancer in your lymph nodes.
For a postmenopausal person (no longer menstruates) with or without cancer in the lymph nodes (positive or negative nodes):
- A score of 0-25 means a low risk of recurrence. Adding chemotherapy to your treatment will not add any benefit. The risks of chemotherapy would outweigh the benefits.
- A score of 26-100 means a high risk of recurrence. The benefits of chemotherapy in preventing recurrence outweigh the risks.
For a premenopausal person (still menstruates) with no cancer found in the lymph nodes (node-negative):
- A score of 0-15 means a low risk of recurrence. Likely the risks of chemotherapy would outweigh the benefits.
- A score of 16-25 means a low to medium risk of recurrence. There may be a small benefit to adding chemotherapy to your treatment. You may get the same benefit by taking medicines to stop your ovaries from making estrogen (called ovarian suppression) along with hormone therapy. Your oncology team will talk about the risks and benefits with you.
- A score of 26-100 means a high risk of recurrence. The benefits of chemotherapy are greater than the risks
For a premenopausal person (still menstruates) with cancer in the lymph nodes (positive nodes):
- If you have a score of 0 to 25, there is benefit to adding chemotherapy to your treatment. You may be able to get the same benefit by taking medicines to stop your ovaries from making estrogen (called ovarian suppression) along with hormone therapy. Your oncology team will talk about the risks and benefits of chemotherapy or ovarian suppression with you.
- A score of 26-100 means a high risk of cancer recurrence. The benefits of chemotherapy are greater than the risks.
Is the test covered by my insurance?
The test costs about $4,000 and is covered by Medicare and many private insurance companies. Exact Sciences (the lab where the test is sent) will help patients and doctors' offices with insurance claims. They also offer financial help to those who qualify. The test could tell you if you need 6 or more months of chemotherapy and help to figure out the related costs, so it is helpful for the patient and insurer.
Resources for More Information
Oncotype IQ
Information and resources for patients and caregivers from Exact Sciences.
My Breast Cancer Treatment
Information and resources for patients and caregivers from Genomic Health/Exact Sciences
https://www.mybreastcancertreatment.org/
Breastcancer.org
https://www.breastcancer.org/symptoms/testing/types/oncotype_dx
References
Burstein, H. J. (2020). Systemic Therapy for Estrogen Receptor-Positive, HER2-Negative Breast Cancer. New England Journal of Medicine, 383(26), 2557-2570.
Kalinsky, K., Barlow, W. E., Gralow, J. R., Meric-Bernstam, F., Albain, K. S., Hayes, D. F., ... & Hortobagyi, G. N. (2021). 21-Gene assay to inform chemotherapy benefit in node-positive breast cancer. New England Journal of Medicine, 385(25), 2336-2347.
Pease, A. M., Riba, L. A., Gruner, R. A., Tung, N. M., & James, T. A. (2019). Oncotype DX® recurrence score as a predictor of response to neoadjuvant chemotherapy. Annals of Surgical Oncology, 26(2), 366-371.
Sparano, J. A., Gray, R. J., Makower, D. F., Pritchard, K. I., Albain, K. S., Hayes, D. F., ... & Sledge Jr, G. W. (2018). Adjuvant chemotherapy guided by a 21-gene expression assay in breast cancer. New England Journal of Medicine, 379(2), 111-121.
Sparano, J. A., Gray, R. J., Ravdin, P. M., Makower, D. F., Pritchard, K. I., Albain, K. S., ... & Sledge Jr, G. W. (2019). Clinical and genomic risk to guide the use of adjuvant therapy for breast cancer. New England Journal of Medicine, 380(25), 2395-2405.
Williams, A. D., McGreevy, C. M., Tchou, J. C., & De La Cruz, L. M. (2020). Utility of Oncotype DX in male breast cancer patients and impact on chemotherapy administration: a comparative study with female patients. Annals of Surgical Oncology, 27, 3605-3611.