ASCO - Breast Cancer Biomarkers Flipbook

Biomarkers in Early Breast Cancer

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Diagnosis Endopredict Î If a patient has ER/PgR-positive, HER2-negative (node-negative) breast cancer, the clinician may use the 12-gene risk score (EndoPredict; Sividon Diagnostics, Köln, Germany) to guide decisions on adjuvant systemic chemotherapy. (Moderate Recommendation; EB-I) Î If a patient has ER/PgR-positive, HER2-negative (node-positive) breast cancer, the clinician should NOT use the 12-gene risk score (EndoPredict) to guide decisions on adjuvant systemic chemotherapy. (Moderate Recommendation; EB-Ins) Î If a patient has HER2-positive breast cancer or TN breast cancer, the clinician should NOT use the 12-gene risk score (EndoPredict) to guide decisions on adjuvant systemic therapy. (Strong Recommendation; IC-Ins) MammaPrint Î (Update of 2016 recommendation 1.7) If a patient has ER/PgR-positive, HER2-negative, node-negative, breast cancer, the MammaPrint assay (MammaPrint; Agendia, Irvine, CA) may be used in those with 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. (Strong Recommendation; EB-H) Î (Update of 2016 recommendation 1.7) If a patient has ER/PgR-positive, HER2- negative, node-negative, breast cancer, the MammaPrint assay should NOT be used in those with low clinical risk per MINDACT categorization to inform decisions on withholding adjuvant systemic chemotherapy since women in the low clinical risk category had excellent outcomes and did not appear to benefit from chemotherapy even with a genomic high risk cancer. (Strong Recommendation; EB-H) Î (Update of 2016 recommendation 1.7) 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. Î (Update of 2016 recommendation 1.7) 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)

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