ASCO Updates Guidelines on Using Biomarkers to Make Adjuvant Treatment Decisions for Women Diagnosed With Early-Stage Invasive Breast Cancer

Save as Favorite
Sign in to receive recommendations (Learn more)

The American Society of Clinical Oncology (ASCO) has updated its guidelines on using biomarkers to make decisions about systemic therapies after surgery to treat women diagnosed with early-stage invasive breast cancer.

The updated ASCO guidelines address using recent results from the TAILORx trial on using the Oncotype DX test to guide use of chemotherapy after surgery for people diagnosed with hormone-receptor-positive, HER2-negative breast cancer that has not spread to the lymph nodes.

The update was published online on July 15, 2019, by the Journal of Oncology Practice. Read the abstract of “Use of Biomarkers to Guide Decisions on Adjuvant Systemic Therapy for Women With Early-Stage Invasive Breast Cancer: ASCO Clinical Practice Guideline Update Summary.”

ASCO is a national organization of oncologists and other cancer care providers. ASCO guidelines give doctors recommendations for treatments and testing that are supported by credible research and experience.

The biomarkers used in this study are certain characteristics in cancer cells that can help predict how the cancer will respond to certain treatments. For example, HER2 status is a biomarker. If a cancer is HER2-positive, it’s very likely that the cancer will respond to anti-HER2 medicines such as Herceptin (chemical name: trastuzumab), Kadcyla (chemical name: T-DM1 or ado-trastuzumab emtansine), Nerlynx (chemical name: neratinib), Perjeta (chemical name: pertuzumab), or Tykerb (chemical name: lapatinib). Other biomarkers include estrogen-receptor status, progesterone-receptor status, and BRCA1 and BRCA2 status.

Adjuvant treatments are treatments given after breast cancer surgery to lower the risk of the cancer coming back (recurrence).

Systemic treatments are treatments that involve the entire body, not just the area where the cancer was. Chemotherapy, hormonal therapy, and targeted therapies are systemic therapies.

When a person is diagnosed with breast cancer, doctors do a biopsy and run a number of tests on the tissue removed to determine the characteristics of the cancer, including hormone-receptor and HER2 status. This information helps guide treatment decisions.

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 likely 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.

Guideline updates

All the updates refer to women diagnosed with early-stage, hormone-receptor-positive, HER2-negative breast cancer that has not spread to the lymph nodes.

The updates say:

  • There is little to no benefit from chemotherapy for women older than 50 with an Oncotype DX Recurrence Score of less than 26. Doctors may offer hormonal therapy after surgery.
  • There is little to no benefit from chemotherapy for women age 50 or younger with an Oncotype DX Recurrence Score of less than 16. Doctors may offer hormonal therapy after surgery.
  • For women age 50 or younger with an Oncotype DX Recurrence Score of 16 to 25, doctors may offer both chemotherapy and hormonal therapy after surgery.
  • No matter their age, women with an Oncotype DX Recurrence Score higher than 30 should be considered candidates for both chemotherapy and hormonal therapy after surgery.
  • Based on expert panel consensus, doctors may offer chemotherapy and hormonal therapy after surgery to women with an Oncotype DX Recurrence Score of 26 to 30.

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 may help you and your doctor make that decision.

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

Reviewed by: Brian Wojciechowski, M.D., medical adviser


Was this article helpful? Yes / No

Fy20octappeal sidebar a
Back to Top