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Guideline: ASCO guidelines recommend olaparib for people with early-stage, high-risk breast cancer and an inherited BRCA mutation

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Contents

At a glance Clinical trials
Updated guidelines Guidelines
What does this mean for me? Questions for your doctor
In-depth: Research behind the update Resources

 

GUIDELINE AT A GLANCE

What is this guideline about?

The American Society of Clinical Oncology (ASCO) updated its guidelines on the management of hereditary breast cancer. The new guidelines now include a recommendation to add one year of the oral olaparib as for people with (or nonmetastatic), breast cancer who have an inherited or mutation and who are at high risk for recurrence. Update: Based on results from the OlympiA Study, on March 11, 2022 the approved as treatment for people with an inherited mutation who have been diagnosed with early-stage HER2-negative breast cancer and are at high risk for recurrence. 

 

Why is this guideline important?

Most people with early-stage breast cancer may be treated successfully and never have their cancer return. Some people, however, particularly those with large tumors, several positive or may have an increased risk for recurrence after treatment ends.

Several methods are used to treat early-stage breast cancer, including surgery, radiation therapy and hormone therapy. In people with breast cancer, a year of such as Herceptin (used for HER2-positive breast cancers) may be used after treatment to keep cancer from coming back. Until olaparib, no targeted therapy was available to specifically keep cancer from returning in people with a BRCA1 or BRCA2 mutation.

PARP inhibitors are a type of targeted therapy that was developed to kill cancer cells in people with a BRCA mutation. These medicines prevent cancer cells from repairing damage, leading to cancer cell death. PARP inhibitors for breast cancer are only approved to treat people with breast cancer.

In June 2021, the early results of the large OlympiA study were published. OlympiA looked at whether treatment with a PARP inhibitor could improve outcomes in women with earlier-stage breast cancer (see our In-depth section for more details). Based on these results ASCO has updated its 2020 guidelines on the treatment of hereditary breast cancer to recommend a year of treatment with the oral PARP inhibitor olaparib after the completion of chemotherapy for people with all the following:

  • early-stage breast cancer
  • HER2-negative breast cancer
  • an in a BRCA1 or a BRCA2 gene
  • an increased risk for recurrence

 

Updated guidelines

The guidelines below are based on results from the OlympiA trial, a phase 3 clinical trial that included 1,836 people with early-stage breast cancer and a BRCA1 or BRCA2 mutation. In this study, people who received the PARP inhibitor olaparib as an add-on treatment after initial therapy (e.g., surgery, chemotherapy, etc.) had reduced cancer recurrence and prolonged life. (All clinical trial participants had HER2-negative breast cancer.)

Based on these results, ASCO updated their recommendations to include offering one year of olaparib to the following people with early-stage breast cancer and a BRCA1 or BRCA2 mutation after completion of or and local treatment (surgery and, or radiation).

  • For people with triple-negative breast cancer who had surgery to remove their cancer before chemotherapy:
    • anyone with a tumor that was larger than 2 cm (3/4 inch)
    • anyone with 1 or more positive lymph nodes
  • For people with triple-negative breast cancer who had neoadjuvant chemotherapy:
    • anyone with residual cancer found at the time of the surgery
  • For people with ER-positive, HER2-negative cancer who had surgery to remove the cancer first (before chemotherapy or hormone therapy):
    • anyone with 4 or more positive lymph nodes
  • For people with ER-positive, HER2-negative cancer who had neoadjuvant therapy
    • anyone with residual cancer found at the time of surgery and a high risk for recurrence based on a “CSP+EG score” (a score used to predict outcomes after neoadjuvant chemotherapy) of 3 or higher 

 

What does this mean for me?

If you have a BRCA1 or BRCA2 mutation and you have been diagnosed with early-stage, HER2-negative breast cancer, you may benefit from additional treatment with olaparib.

If you have been diagnosed with early-stage, HER2-negative breast cancer and you do not know if you have a BRCA1 or BRCA2 mutation, genetic testing for an inherited mutation can help you learn if you might benefit from additional treatment with olaparib.

Although use of olaparib has been added to the ASCO and NCCN guidelines for early-stage breast cancer, it is important to note that olaparib has not yet received FDA approval in the early-stage breast cancer setting, and some health plans may not cover the cost for this treatment.

 

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posted 8/6/21

 

References

ASCO Releases Rapid Guideline Recommendation Update for Certain Patients With Hereditary Breast Cancer. American Society of Clinical Oncology. Published June 15, 2021.

Tung N, Boughey J, Pierce L, et al. Management of Hereditary Breast Cancer: American Society of Clinical Oncology, American Society for Radiation Oncology, and Society of Surgical Oncology Guideline. Journal of Clinical Oncology. 2020 Jun 20;38(18):2080-2106. Published online April 3, 2020.

Tutt ANJ, Garber JE, Kaufman B, et al. OlympiA Clinical Trial Steering Committee and Investigators. Adjuvant Olaparib for Patients with BRCA1- or BRCA2-Mutated Breast Cancer. New England Journal of Medicine. 2021 Jun 24;384(25):2394-2405. Published ahead of print June 3, 2021.

 

Disclosure

FORCE receives funding from industry sponsors, including companies that manufacture cancer drugs, tests and devices. All XRAYS articles are written independently of any sponsor and are reviewed by members of our Scientific Advisory Board prior to publication to assure scientific integrity.

This article is relevant for:

People with early-stage HER2-negative breast cancer and an inherited BRCA mutation

This article is also relevant for:

people with breast cancer

people newly diagnosed with cancer

Be part of XRAY:

Expert Guidelines
Expert Guidelines

National Comprehensive Cancer Network guidelines regarding who should undergo genetic counseling and testing recommend speaking with a genetics expert about genetic testing if you have been diagnosed with breast cancer and any of the following apply to you:     

  • You have a blood relative who has tested positive for an inherited mutation 
  • You have any of the following:  
    • Breast cancer at age 50 or younger. 
    • Male breast cancer at any age.
    • Ovarian cancer at any age. 
    • Triple-negative breast cancer at any age.
    • Two separate breast cancer diagnoses.
    • Eastern European Jewish ancestry and breast cancer at any age.
    • Lobular breast cancer and a family history of diffuse gastric cancer.
    • HER2-negative breast cancer and are at high-risk for recurrence.
    • Tumor testing shows a mutation in a gene that is associated with .

OR 

  • You have one or more close family members who have had:  
    • Young-onset or rare cancers.
    • Breast cancer at age 50 or younger.
    • Triple-negative breast cancer.
    • Male breast cancer, ovarian cancer, pancreatic cancer or metastatic prostate cancer at any age.
    • Two separate cancer diagnoses.
    • Metastatic prostate cancer or prostate cancer that is high-risk or very-high-risk. 

The American Society of Breast Cancer Surgeons (ASBrS) released guidelines in 2019 recommending that all women diagnosed with breast cancer have access to genetic testing for inherited mutations in breast cancer genes. 

If you are uncertain whether you meet the guidelines above and you are interested in or considering genetic testing, you should speak with a cancer genetics expert

Updated: 07/28/2023

Expert Guidelines
Expert Guidelines

National Comprehensive Cancer Network (NCCN) guidelines address treating early-onset breast cancer in people with an inherited BRCA1 or BRCA2 mutation. For people who are at high risk for recurrence, the NCCN recommends considering a year of maintenance therapy with olaparib after chemotherapy is completed.  

Updated: 06/06/2022

Questions To Ask Your Doctor
Questions To Ask Your Doctor

  • Are PARP inhibitors recommended for my type of breast cancer?
  • Will my insurance pay for PARP inhibitor treatment?
  • Should I be tested for an inherited mutation in a BRCA1 or BRCA2 gene or another gene that is linked to breast cancer?
  • I have a mutation in a gene other than BRCA1 or BRCA2; would PARP inhibitors be helpful for treating my cancer?
  • How long will I have to use PARP inhibitors?
  • What are the side effects of PARP inhibitors?

Who covered this study?

Physician’s Weekly

ASCO Updates Recommendations for Managing Hereditary Breast Cancer This article rates 4.0 out of 5 stars

Oncology Nursing News

New ASCO Guideline Recommends Adjuvant Olaparib for Patients with Hereditary Breast Cancer This article rates 4.0 out of 5 stars

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