ASCO - Breast Cancer Biomarkers Flipbook 2019

Diagnosis ➤ If a patient has ER/PgR-positive, HER2-negative, node-positive, breast cancer, the MammaPrint assay may be used in patients with 1-3 positive nodes and at high clinical risk per MINDACT categorization to inform decisions on withholding adjuvant systemic chemotherapy due to its ability to identify a good prognosis population with potentially limited chemotherapy benefit. (Moderate Recommendation; EB-H) • However, such patients should be informed that a benefit of chemotherapy cannot be excluded, particularly in patients with greater than one involved lymph node. ➤ If a patient has ER/PgR-positive, HER2-negative, node-positive, breast cancer, the MammaPrint assay should NOT be used in patients with 1-3 positive nodes and at low clinical risk per MINDACT categorization to inform decisions on withholding adjuvant systemic chemotherapy. There are insufficient data on the clinical utility of MammaPrint in this specific patient population. (Moderate Recommendation; IC-L) ➤ If a patient has HER2-positive breast cancer, the clinician should NOT use the MammaPrint assay to guide decisions regarding adjuvant systemic therapy. (Moderate Recommendation; IC-L) • Additional studies are required to address the role of MammaPrint in patients with this tumor subtype who are also receiving HER2-targeted therapy. ➤ If a patient has ER/PgR negative and HER2-negative breast cancer (triple negative), the clinician should NOT use the MammaPrint assay to guide decisions about adjuvant systemic chemotherapy. (Strong Recommendation; IC-Ins) PAM50 Risk of Recurrence Score ➤ If a patient has ER/PgR-positive, HER2-negative (node-negative) breast cancer, the clinician may use the PAM50 risk of recurrence (ROR) score (Prosigna Breast Cancer Prognostic Gene Signature Assay; NanoString Technologies, Seattle, WA), in conjunction with other clinicopathologic variables, to guide decisions on adjuvant systemic therapy. (Strong Recommendation; EB-H) ➤ If a patient has ER/PgR-positive, HER2-negative (node-positive) breast cancer, the clinician should NOT use the PAM50-ROR to guide decisions on adjuvant systemic therapy. (Moderate Recommendation; EB-I) ➤ If a patient has HER2-positive breast cancer, the clinician should NOT use the PAM50-ROR to guide decisions on adjuvant systemic therapy. (Strong Recommendation; IC-Ins) ➤ If a patient has TN breast cancer, the clinician should NOT use the PAM50-ROR to guide decisions on adjuvant systemic therapy. (Strong Recommendation; IC-Ins)

• Cover