Updated ASCO Guideline for the Use of Biomarkers in Early-Stage Breast Cancer

By: Sarah Campen, PharmD
Posted: Thursday, July 21, 2022

The American Society of Clinical Oncology (ASCO) updated its guidelines for the appropriate use of breast cancer biomarker assay results to guide treatment decisions in early-stage breast cancer. An expert panel, co-chaired by Fabrice Andre, MD, of Institute Gustave Roussy, Paris, and Vered Stearns, MD, of Johns Hopkins University, Baltimore, published its recommendations in the Journal of Clinical Oncology.

“This report aims to provide more precise guidelines on how to use previously endorsed genomic tests and to provide recommendations on the use of new biomarkers to guide endocrine and chemotherapy recommendations in individuals with estrogen receptor–positive, HER2-negative tumors, and in those with HER2-positive or triple-negative breast cancer,” stated the panel members.

Three questions were reviewed for the update:

1. For patients with early-stage estrogen receptor–positive, HER2-negative breast cancer, which biomarkers should be used to guide decisions on adjuvant endocrine and chemotherapy for a newly diagnosed cancer or in the extended setting?
2. For patients with early-stage HER2-positive breast cancer, which biomarkers should be used to guide decisions on adjuvant endocrine and chemotherapy?
3. For patients with early-stage triple-negative breast cancer, which biomarkers should be used to guide decisions on adjuvant chemotherapy?

Under the new guidelines, Oncotype DX, MammaPrint, Breast Cancer Index, and EndoPredict are all recommended for guiding decision-making in postmenopausal women with estrogen receptor–positive, HER2-negative breast cancer that is either lymph node–negative or with one to three positive nodes. For premenopausal women with estrogen receptor–positive, HER2-negative breast cancer that is node-negative, Oncotype DX is the sole assay recommended for use in guidance of therapeutic decisions. No genomic tests have been recommended for patients with HER2-positive breast cancer, triple-negative breast cancer, or those with four or more positive lymph nodes due to a lack of data in these groups.

Disclosure: For full disclosures of the study authors, visit ascopubs.org.

Journal of Clinical Oncology

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