ASCO GUIDELINES Bundle

Breast Cancer Biomarkers

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Diagnosis Protein Encoded By The MKI67 Gene ➤ Protein encoded by the MKI67 gene labeling index by IHC should NOT be used to guide choice on adjuvant chemotherapy. (Moderate Recommendation; EB-I) Extended Endocrine Therapy ➤ If a patient has ER/PgR-positive, HER2-negative (node-negative) breast cancer and has had 5 years of endocrine therapy without evidence of recurrence, the clinician should NOT use multiparameter gene expression or protein assays (Oncotype DX, EndoPredict, PAM50, Breast Cancer Index, or IHC4) to guide decisions on extended endocrine therapy. (Moderate Recommendation; EB-I) Additional Biomarkers to Guide Specific Drug/Regimen Choice Tamoxifen ➤ The clinician should NOT use CYP2D6 polymorphisms to guide adjuvant endocrine therapy selection. (Moderate Recommendation; EB-I) ➤ The clinician should NOT use p27 expression by IHC to guide adjuvant endocrine therapy selection. (Strong Recommendation; IC-L) Aromatase Inhibitors ➤ The clinician should NOT use protein encoded by the MKI67 gene labeling index by IHC to guide adjuvant endocrine therapy selection. (Moderate Recommendation; EB-I) Taxanes ➤ The clinician should NOT use microtubule-associated protein Tau mRNA expression or mRNA expression by IHC to guide adjuvant chemotherapy selection. (Moderate Recommendation; EB-I) ➤ The clinician should NOT use HER1/epidermal growth factor receptor expression by IHC to guide adjuvant chemotherapy selection. (Moderate Recommendation; EB-L) Anthracyclines ➤ The clinician should NOT use TOP2A gene amplification or TOP2A protein expression by IHC to guide adjuvant chemotherapy selection. (Moderate Recommendation; EB-H) ➤ The clinician should NOT use HER2 and TOP2A gene coamplification; CEP17 duplication; or TIMP-1, FOXP3, or p53 to guide adjuvant chemotherapy selection. (Moderate Recommendation; EB-I)

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