Adding Clinical Risk of Recurrence to Oncotype DX Score Can Help Make Chemotherapy Decisions for Younger Women With Early-Stage Breast Cancer

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When women 50 and younger diagnosed with early-stage hormone-receptor-positive, HER2-negative breast cancer that has not spread to the lymph nodes have an Oncotype DX Recurrence Score of 16 to 25, adding clinical risk of recurrence information can help determine who will benefit from chemotherapy after surgery, according to the latest analysis of results from the TAILORx trial.

The research was presented on June 3, 2019, at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting and published online the same day in The New England Journal of Medicine.

About the Oncotype DX test for early-stage breast cancer

The Oncotype DX genomic test for early-stage breast cancer 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 return
  • whether you’re likely to benefit from chemotherapy if you’re being treated for early-stage invasive breast cancer

Oncotype DX test results assign a Recurrence Score — a number between 0 and 100 — to the early-stage breast cancer. Based on your age, you and your doctor can use the following ranges to interpret your results for early-stage invasive cancer.

For women older than 50 years of age:

  • Recurrence Score of 0–25: The cancer has a low risk of recurrence. The benefits of chemotherapy likely will not outweigh the risks of side effects.
  • Recurrence Score of 26–100: The cancer has a high risk of recurrence. The benefits of chemotherapy are likely to be greater than the risks of side effects.

For women age 50 and younger:

  • Recurrence Score of 0–15: The cancer has a low risk of recurrence. The benefits of chemotherapy likely will not outweigh the risks of side effects.
  • Recurrence Score of 16–20: The cancer has a low to medium risk of recurrence. The benefits of chemotherapy likely will not outweigh the risks of side effects.
  • Recurrence Score of 21–25: The cancer has a medium risk of recurrence. The benefits of chemotherapy will probably be greater than the risks of side effects.
  • Recurrence Score of 26–100: The cancer has a high risk of recurrence. The benefits of chemotherapy will likely be greater than the risks of side effects.

About the TAILORx trial

The TAILORx trial (Trial Assigning IndividuaLized Options for Treatment) is a large, ongoing study looking at how the Oncotype DX test can help people and their doctors make decisions about chemotherapy after breast cancer surgery.

The TAILORx study is a prospective study. A prospective study follows a group of similar people who are different in terms of the factors being studied to see how the factors affect the rates of a certain outcome.

The TAILORx study included 10,273 women diagnosed with hormone-receptor-positive, HER2-negative breast cancer that had not spread to the lymph nodes. The researchers performed Oncotype DX tests on tissues samples from all the cancers, and all the women were then assigned an Oncotype DX Recurrence Score:

  • women with a Recurrence Score of 0 to 10 were assigned to receive hormonal therapy alone (meaning they didn’t get chemotherapy) — 1,626 women were in this group (15.9% of the women in the study)
  • women with a Recurrence Score of 11 to 25 were randomly assigned to received either:
    • chemotherapy plus hormonal therapy
    • hormonal therapy alone
    6,897 women were in this group (67.3% of the women in the study)
  • women with a Recurrence Score of 26 or higher were assigned to receive chemotherapy plus hormonal therapy — 1,730 women were in this group (16.9% of the women in the study)

The researchers continue to follow the women to see how many women in each group have had a recurrence. Results from the TAILORx trial published in 2015 found that women with a Recurrence Score between 0 and 10 can safely be treated only with hormonal therapy after surgery, allowing them to skip chemotherapy. Results published in 2018 found that women older than 50 with a Recurrence Score between 11 to 25 and women 50 and younger with a Recurrence Score between 11 and 15 could safely skip chemotherapy after surgery.

The new findings

Researchers wondered if adding information about clinical risk of recurrence to the Oncotype DX Recurrence Score could further clarify who would and would not benefit from chemotherapy after surgery.

For this analysis, the researchers classified clinical risk of recurrence of breast cancer as low or high based on the cancer’s size and grade.

Cancers with a low clinical risk of recurrence were:

  • 3 cm or smaller and low grade
  • smaller than 2 cm and intermediate grade
  • 1 cm or smaller and high grade

Cancers with a high clinical risk of recurrence were:

  • any cancer that was not classified as low clinical risk of recurrence

The researchers had a Recurrence Score and clinical risk of recurrence information for 9,427 women in the study:

  • 70% were considered to have low clinical risk of recurrence
  • 30% were considered to have high clinical risk of recurrence

Overall, the researchers found that clinical risk of recurrence information added more prognostic information to the Recurrence Score, but it didn’t help determine whether chemotherapy would be beneficial.

Still, when the researchers looked specifically at women age 50 and younger with a Recurrence Score of 16 to 25, they found that clinical risk of recurrence information could help identify who would benefit from chemotherapy. The results suggest that women age 50 and younger with a Recurrence Score of 16 to 25 with a low clinical risk of recurrence don’t get much benefit from chemotherapy after surgery.

"Last year's TAILORx results gave clinicians high-quality data to inform personalized treatment recommendations for women," lead author Joseph A. Sparano, M.D., associate director for clinical research at the Albert Einstein Cancer Center and Montefiore Health System, said in a statement. "With this new analysis, it is clear that women ages 50 or younger with a Recurrence Score result between 16 and 20 and at low risk, clinically, do not need chemotherapy. Furthermore, the integration of the Recurrence Score with clinical risk information could identify premenopausal women with higher clinical risk who may benefit from ovarian function suppression and more aggressive anti-estrogen therapy."

What this means for you

If you’ve been diagnosed with early-stage hormone-receptor-positive, HER2-negative breast cancer that has not spread to the lymph nodes and are weighing the pros and cons of adding chemotherapy to your treatment plan, the Oncotype DX test, as well as the clinical risk of recurrence classification,1 may help you and your doctor make that decision, especially if you are age 50 or younger.

Besides any genomic test results, you and your doctor will consider a number of factors when developing your treatment plan, such as:

  • your age
  • the size of the cancer
  • hormone receptor protein levels
  • the grade of the cancer
  • any other health conditions you have
  • your family history of cancer
  • your personal preferences

Together, you can make the best treatment decisions for you.

Written by: Jamie DePolo, senior editor


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