Genomic tests such as the Oncotype DX analyze a group of genes in cancer cells with regards to their possible behavior and response to treatment. It helps doctors predict whether cancer, such as breast cancer, will recur (or return) after chemotherapy or radiation therapy. This aids doctors and patients in choosing their best option of treatment. Who could be a candidate for oncotype DX test? What do the test results mean?

How Is Oncotype DX Test Used?

Oncotype DX testing may be used in one of two ways:

• It can help doctors evaluate a patient’s risk of cancer recurrence (cancer coming back), particularly in women who have early-stage breast cancer that is estrogen-receptor-positive (ER+), as well as the likelihood of a patient benefitting from chemotherapy after surgical treatment.
• It can help doctors evaluate cancer recurrence in patients with ductal carcinoma in situ (DCIS), and/or one’s risk of developing a new type of invasive cancer in the same breast, and one’s likelihood of benefitting from radiation therapy after surgical treatment of DCIS.

Who May Be a Candidate for Oncotype DX Test?

Patients who make good candidates for taking the Oncotype DX test include:

• patients who have recently been diagnosed with invasive breast cancer (stage I or II)
• patients who have ER+ breast cancer
• those whose lymph nodes are free of cancer
• patients who have decided on treatments using chemotherapy

Most patients who have early-stage ER+ breast cancers that have not spread to the lymph nodes have a low risk for cancer recurrence. After breast cancer surgery, hormonal therapy using aromatase inhibitors or tamoxifen may be prescribed to reduce one’s risk of cancer recurrence.

The Oncotype DX test helps you and the doctor to decide if you need chemotherapy. Research suggests that the test may also help postmenopausal women with ER+ breast cancer that has spread to their lymph nodes to decide on chemotherapy.

Other candidates for Oncotype DX test include:

• women who have recently been diagnosed with DCIS
• women who have had lumpectomy (surgical removal) for DCIS

DCIS is a non-invasive type of breast cancer that is common. It is usually treated by removing the tumor surgically (lumpectomy). Hormonal treatment may be recommended after surgery if the tumor is positive for hormone receptors. Radiation therapy is another option, for which the Oncotype DX test can assist in making a more informed decision.

How does Oncotype DX Test Work?

While genetic tests look for gene mutations that are passed from one generation to another (inherited), a genomic test like the Oncotype DX test evaluates the activity of groups of genes, which can affect how cancer is likely to respond to treatment. The test involves looking at a sample of tissue and analyzing the behavior of 21 genes, which control the activities of cancer cells. This is a relatively new test that helps determine the prognosis (outcome) of treatment and predict the likelihood that one will benefit from chemotherapy or radiotherapy.

What do the Test Results Mean?

Results of the Oncotype DX test give the patient a Recurrence Score (0 to 100), which may be interpreted as:

• Lower than 18: There is a low risk of recurrence of DCIS. It is likely that the benefits of chemotherapy for breast cancer in its early stages or radiation therapy for DCIS is small and may not compensate for the risks of its side effects.
• Between 18 to 31: There is an intermediate risk of cancer recurrence and it is not clear whether the benefits of treatment will outweigh the risks of its side effects.
• Greater than 31: There is a high risk of cancer recurrence; therefore, the benefits of chemotherapy for breast cancer (early stage) or radiotherapy for DCIS outweigh the risks of their side effects.

The decision to undergo either chemotherapy or radiation therapy will also depend on other factors, such as your age, the tumor size and cancer grade, and whether you have many or few hormone receptors in your cancer cells.

Is Oncotype DX Test Covered by Insurance?

Oncotype DX test is covered by the US Medicare program and by many insurance companies. Most insured members have plans that cover the genomic test. However, in case your plan does not include the test, ask your health provider to work out a solution with the insurance company.

The Genomic Access Program has been started by Genomic Health to assist patients in verifying coverage and in obtaining reimbursements. Financial assistance programs and payment plans are also available for patients who are underinsured or uninsured. The test costs approximately $4,000. Call 1-866-ONCOTYPE (1-866-662-6897) for more information on these matters.