Oncotype DX Tests
There are two Oncotype DX tests — one for invasive breast cancer and one for DCIS (non-invasive breast cancer:
The Oncotype DX Breast Recurrence Score Test can be used if you’re diagnosed with early-stage, estrogen receptor-positive, HER2-negative invasive breast cancer.
The Oncotype DX Breast DCIS Score Test can be used if you’re diagnosed with DCIS (ductal carcinoma in situ).
The Oncotype DX tests are genomic tests. Genomic tests analyze certain genes in a sample of a cancer tumor to see how active they are. The activity level of these genes affects how likely the cancer is to grow and spread. The Oncotype DX tests are used to help make decisions about whether chemotherapy or radiation after surgery would help lower the risk of the breast cancer or DCIS coming back (also known as recurrence).
Note that genomic tests are different from genetic tests. Genetic testing detects inherited changes (also called mutations) in a gene linked to a higher risk of breast cancer. Genetic tests are done on a sample of blood or saliva and can be done whether or not someone has been diagnosed with breast cancer.
What is the Oncotype DX Breast Recurrence Score Test?
The Oncotype DX Breast Recurrence Score Test analyzes the activity of a group of genes that can affect how an early-stage breast cancer is likely to behave and respond to treatment. The Oncotype DX Breast Recurrence Score Test is used in two ways:
to help doctors figure out a person’s risk of early-stage, estrogen receptor-positive breast cancer coming back in a part of the body away from the breast (distant or metastatic recurrence)
to help figure out if a person will benefit from chemotherapy
The results of the Oncotype DX Breast Recurrence Score Test, combined with other features of the cancer, can help you make a more informed decision about whether or not to have chemotherapy after surgery to treat early-stage, hormone receptor-positive, HER2-negative breast cancer.
Who is eligible for the Oncotype DX Breast Recurrence Score Test?
You may be a candidate for the Oncotype DX Breast Recurrence Score Test if:
you’ve recently been diagnosed with stage I, stage II, or stage IIIa invasive breast cancer
the cancer is estrogen receptor-positive
the cancer is HER2-negative
the cancer is lymph node-negative or has spread to no more than three lymph nodes
you and your doctor are making decisions about chemotherapy after surgery
Most early-stage, estrogen receptor-positive, HER2-negative breast cancers are treated with a hormonal therapy medicine, such as an aromatase inhibitor or tamoxifen, after breast cancer surgery to reduce the risk that the cancer will come back in the future. Whether or not chemotherapy is also necessary isn’t always clear.
If you’ve been diagnosed with early-stage, estrogen receptor-positive, HER2-negative breast cancer, the Oncotype DX Breast Recurrence Score Test can help you and your doctor make a more informed decision about whether or not you will benefit from chemotherapy.
How does the Oncotype DX Breast Recurrence Score Test work?
The Oncotype DX Breast Recurrence Score Test analyzes the activity of 21 genes that can influence how likely a cancer is to grow and respond to treatment.
Looking at these 21 genes can provide specific information on:
the likelihood that the breast cancer will come back (recur)
whether you’re likely to benefit from chemotherapy after surgery
So the Oncotype DX Breast Recurrence Score Test is a prognostic test, since it provides more information about how likely (or unlikely) the breast cancer is to come back. And it’s also a predictive test, since it predicts how likely a person is to benefit from chemotherapy . Studies have shown that Oncotype DX Breast Recurrence Score Test is useful for both purposes.
The Oncotype DX Breast Recurrence Score Test assigns a Recurrence Score — a number between 0 and 100 — to the early-stage breast cancer. Based on menopausal status, you and your doctor can use the following ranges to interpret your results for early-stage invasive cancer.
What are the Oncotype DX Breast Recurrence Scores?
For post-menopausal women diagnosed with cancer that is lymph node-positive or lymph node-negative:
Recurrence Score of 0–25: The cancer has a lower risk of recurrence. The benefits of chemotherapy are small and likely won’t outweigh the risks of side effects.
Recurrence Score of 26–100: The cancer has a higher risk of recurrence. The benefits of chemotherapy are likely to be greater than the risks of side effects.
For pre-menopausal women diagnosed with lymph node-negative breast cancer:
Recurrence Score of 0–15: The cancer has a lower risk of recurrence. The benefits of chemotherapy are small and likely won’t outweigh the risks of side effects.
Recurrence Score of 16–25: The cancer has a low to medium risk of recurrence. Having chemotherapy after surgery may offer a small benefit. You may get the same benefit by taking medicine to shut down your ovaries (called ovarian suppression) along with hormonal therapy. You and your doctor will discuss the risks and benefits of both options.
Recurrence Score of 26–100: The cancer has a higher risk of recurrence. The benefits of chemotherapy are likely to be greater than the risks of side effects.
For pre-menopausal women diagnosed with lymph node-positive breast cancer:
Recurrence Score of 0–25: The cancer has a low to medium risk of recurrence. Having chemotherapy after surgery may offer benefits. You may get the same benefits by taking medicine to shut down your ovaries (called ovarian suppression) along with hormonal therapy. You and your doctor will discuss the risks and benefits.
Recurrence Score of 26–100: The cancer has a higher risk of recurrence. The benefits of chemotherapy are likely to be greater than the risks of side effects.
You and your doctor will consider the Recurrence Score in combination with other factors, such as the size and grade of the cancer and the number of hormone receptors the cancer cells have (many vs. few). Together, you can make a decision about whether or not you should have chemotherapy.
What is the Oncotype DX Breast DCIS Score?
The Oncotype DX Breast DCIS Score is used:
to help doctors figure out a person’s risk of DCIS coming back in the same breast and/or the risk of a new invasive cancer developing in the same breast
how likely someone is to benefit from radiation therapy after DCIS surgery; with DCIS, doctors aren’t always sure which women will benefit from radiation therapy.
The results of the Oncotype DX Breast DCIS Score Test can help you and your doctor make a more informed decision about whether or not you need radiation therapy.
Who’s eligible for the Oncotype DX Breast DCIS Score Test?
You may be a candidate for the Oncotype DX Breast DCIS Score Test if:
you’ve recently been diagnosed with DCIS
you’re having lumpectomy to remove the DCIS or have had a core biopsy
How does the Oncotype DX Breast DCIS Score Test work?
The Oncotype DX Breast DCIS Score Test analyzes the activity of 12 genes that can influence how likely the DCIS is to come back in the same breast, either as another DCIS or as invasive breast cancer.
The Oncotype DX Breast DCIS Score Test assigns a Recurrence Score — a number between 0 and 100 — to the DCIS. You and your doctor can use the following ranges to interpret your results for DCIS:
Recurrence Score lower than 39: The DCIS has a low risk of recurrence. The benefit of radiation therapy is likely to be small and won’t outweigh the risks of side effects.
Recurrence Score between 39 and 54: The DCIS has an intermediate risk of recurrence. It’s unclear whether the benefits of radiation therapy outweigh the risks of side effects.
Recurrence Score greater than 54: The DCIS has a high risk of recurrence, and the benefits of radiation therapy are likely to be greater than the risks of side effects.
You and your doctor will consider the Recurrence Score together with other factors, such as the size and grade of the DCIS and the number of hormone receptors the cancer cells have (many vs. few). Together, you can make a decision about whether or not you should have radiation therapy.
Insurance coverage and financial assistance for Oncotype DX tests
The Medicare program and many other insurance companies cover the Oncotype DX tests. If you discover that your plan does not cover the Oncotype DX test that’s right for you, talk to your doctor; they may be able to work with your insurance company to get the test covered.
Abbott, the company that makes the Oncotype DX tests, has a Patient Assistance Program to help people navigate the billing and insurance process for the Oncotype DX tests.