ASCO Issues Guideline on Biomarker-Based Adjuvant Breast Cancer Treatment

The American Society of Clinical Oncology (ASCO) has published a guideline on biomarker use to guide decisions for adjuvant systemic treatment for women with early-stage, invasive breast cancer. The guideline was published in the Journal of Clinical Oncology.

Besides the use of assays to identify women with estrogen receptor (ER)- and/or progesterone receptor (PR)-positive or human epidermal growth factor receptor 2 (HER2)-positive diseases, the authors found satisfactory clinical trial data and prospective-retrospective studies to recommend the use of six biomarker assays in specific patient subgroups.

The guideline panel found sufficient evidence to include Oncotype DX, EndoPredict, PAM50, Breast Cancer Index, and urokinase plasminogen activator and plasminogen activator inhibitor type 1 assays.

Daniel F. Hayes, MD, clinical director of the breast oncology program at the University of Michigan Comprehensive Cancer Center, and colleagues identified one randomized clinical trial and 18 prospective-retrospective studies that evaluated the clinical utility of specific biomarkers for use in guiding adjuvant treatment decisions in breast cancer.

“A biomarker-based test is judged to have clinical utility if use of the test is associated with a favorable balance of benefits to harms compared with treatment of the patient in the absence of the biomarker test result,” the authors wrote.

The authors of the guideline recommend that clinicians educate patients, family members, and/or caregivers on the results of pathology tests and how the results are used to tailor treatment decisions based on the biology of the tumor.

Select Strong Recommendations:

• If a patient has ER/PR-positive, HER2-negative (node-negative) breast cancer, the clinician may use the 21-gene recurrence score (Oncotype DX) to guide decisions on adjuvant systemic chemotherapy.

• If a patient has HER2-positive breast cancer or triple-negative breast cancer, the clinician should not use the 21-gene recurrence score (Oncotype DX) to guide decisions on adjuvant systemic therapy.

• If a patient has HER2-positive breast cancer or triple-negative breast cancer, the clinician should not use the 12-gene risk score (EndoPredict) to guide decisions on adjuvant systemic therapy.

• If a patient has triple-negative breast cancer, the clinician should not use the 70-gene assay (MammaPrint) to guide decisions on adjuvant systemic therapy.

• If a patient has ER/PR-positive, HER2-negative (node-negative) breast cancer, the clinician may use the PAM50 risk-of-recurrence score (Prosigna Breast Cancer Prognostic Gene Signature Assay) in conjunction with other clinicopathologic variables to guide decisions on adjuvant systemic therapy.

­• If a patient has HER2-positive or triple-negative breast cancer, the clinician should not use the PAM50 risk-of-recurrence score to guide decisions on adjuvant systemic therapy.

• If a patient has ER/PR-positive, HER2-negative (node-positive) breast cancer, HER2-positive breast cancer, or triple-negative breast cancer, the clinician should not use the Breast Cancer Index to guide decisions on adjuvant systemic therapy.

ASCO has also recently published a separate guideline to guide decisions on systemic therapy for women with metastatic breast cancer.