What are ASCO guidelines for use of biomarkers in the treatment of breast cancer?

Updated: Dec 27, 2019
  • Author: Pavani Chalasani, MD, MPH; Chief Editor: John V Kiluk, MD, FACS  more...
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Answer

A guideline from the American Society of Clinical Oncology (ASCO) advises that the only biomarkers that can guide choices of specific treatment regimens in breast cancer are as follows [197] :

  • Estrogen receptor (ER)
  • Progesterone receptor (PR)
  • Human epidermal growth factor receptor 2 (HER2)

ASCO recommendations regarding further biomarker use include the following [197] :

  • The Oncotype DX 21-gene recurrence score may be used in patients with ER/PR-positive, HER2-negative (node-negative) breast cancer; however, it should not be used in patients with HER2-positive or triple-negative (ER,PR, HER2 negative) breast cancer
  • The EndoPredict 12-gene risk score may be used in patients with ER/PR-positive, HER2-negative (node-negative) breast cancer; however, it should not be used in patients with ER/PR-positive, HER2-negative (node-positive) breast cancer or in patients with HER2-positive or triple-negative breast cancer
  • The MammaPrint (Agendia) 70-gene assay should not be used in patients with triple-negative breast cancer; in patients with ER/PR-positive, HER2-negative (node-positive or node-negative) breast cancer; or in patients with HER2-positive breast cancer
  • PAM50 risk of recurrence score may be used, in combination with other clinicopathologic variables, in patients with ER/PR-positive, HER2-negative (node-negative) breast cancer; however, it should not be used in patients with ER/PR-positive, HER2-negative (node-positive) breast cancer or in patients with HER2-positive or triple-negative breast cancer
  • The Breast Cancer Index may be used in patients with ER/PR-positive, HER2-negative (node-negative) breast cancer; however, it should not be used in patients with ER/PR-positive, HER2-negative (node-positive) breast cancer or in patients with HER2-positive or triple-negative breast cancer
  • The Mammostrat (Clarient) five-protein assay should not be used in patients with ER/PR-positive, HER2-negative (node-positive or node-negative) breast cancer or in patients with HER2-positive or triple-negative breast cancer.
  • Immunohistochemistry 4 may be used in patients with ER/PR-positive, HER2-negative (node-negative) breast cancer; however, it should not be used in patients with HER2-positive or triple-negative breast cancer
  • Urokinase plasminogen activator and plasminogen activator inhibitor type 1 may be used in patients with ER/PR-positive, HER2-negative (node-negative) breast cancer; however, they should not be used in patients with HER2-positive breast cancer or triple-negative breast cancer
  • Circulating tumor cells should not be used to guide decisions on adjuvant systemic therapy
  • Tumor-infiltrating lymphocytes should not be used in patients with ER/PR-positive, HER2-negative (node-positive or node-negative) breast cancer or in patients with HER2-positive or triple-negative breast cancer
  • Protein encoded by the MKI67 gene should not be used to guide the selection of adjuvant chemotherapy
  • CYP2D6 polymorphisms or p27 expression determined by immunohistochemistry should not be used to guide the selection of adjuvant tamoxifen
  • Protein encoded by the immunohistochemistry MKI67 gene labeling index should not be used to guide the selection of adjuvant aromatase inhibitors
  • For patients with ER/PR-positive, HER2-negative (node-negative) breast cancer who have had 5 yr of endocrine therapy without evidence of recurrence, clinicians should not use multiparameter gene expression or protein assays (Oncotype DX, EndoPredict, PAM50, Breast Cancer Index, or immunohistochemistry 4) to guide decisions on extended endocrine therapy
  • Clinicians should not use microtubule-associated protein Tau messenger (m)RNA expression or mRNA expression determined by immunohistochemistry or HER1/epidermal growth-factor receptor expression by immunohistochemistry to guide the selection of adjuvant taxanes
  • Clinicians should not use TOP2A gene amplification or TOP2A protein expression determined by immunohistochemistry and should not use HER2 and TOP2A gene coamplification, CEP17 duplication, TIMP-1, FOXP3, or p53 to guide the selection of adjuvant anthracyclines

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