Biomarkers for Early-Stage Invasive Breast Cancer Clinical Practice Guidelines (ASCO, 2019)

American Society of Clinical Oncology

This is a quick summary of the guidelines without analysis or commentary. For more information, go directly to the guidelines by clicking the link in the reference.

August 30, 2019

The American Society of Clinical Oncology (ASCO) published recommendations on the use of biomarkers for decision making regarding adjuvant systemic treatment for women with early-stage invasive breast cancer in April 2016.[1] In August 2017 and August 2019, ASCO released focused updates of these guidelines.[2,3] The combined recommendations are summarized below.

ASCO advises that the only biomarkers that can guide choices of specific treatment regimens in breast cancer are estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor 2 (HER2).[1] However, certain biomarker assays have shown sufficient evidence of clinical utility in specific subgroups of breast cancer: Oncotype DX, EndoPredict, PAM50, Breast Cancer Index (BCI), and urokinase plasminogen activator (uPA) and plasminogen activator inhibitor 1 (PAI-1).

The Oncotype DX 21-gene recurrence score (RS) may be used in patients with ER/PR-positive, HER2-negative (node-negative) breast cancer.[1] However, it should not be used in patients with ER/PR-positive, HER2-negative (node-positive) breast cancer; HER2-positive breast cancer; or triple-negative (ER-, PR-, HER2-negative) breast cancer.

  • Patients older than 50 years with Oncotype DX RSs below 26 and those aged 50 years or younger with Oncotype DX RSs below 16: Chemotherapy provides little to no benefit; clinicians may offer endocrine therapy alone.[3]

  • Patients aged 50 years or younger with Oncotype DX RSs of 16 to 25: Clinicians may offer endocrine therapy.[3]

  • Patients with Oncotype Dx RSs of 26 to 30: Based on Expert Panel consensus, oncologists may offer chemoendocrine therapy.[3]

  • Patients with Oncotype Dx RSs over 30: Consider for chemoendocrine therapy.[3]

The EndoPredict 12-gene RS or the BCI may be used in patients with ER/PR-positive, HER2-negative (node-negative) breast cancer.[1] However, neither assay should 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 70-gene assay may be used in patients with ER/PR-positive, HER2-negative (node-negative) breast cancer who have high clinical risk per MINDACT (microarray in node-negative) categorization to guide decisions on withholding adjuvant systemic chemotherapy or in those with ER/PR-positive, HER2-negative (node-positive) breast cancer who have one to three positive nodes and are at high clinical risk (inform patients a benefit of chemotherapy cannot be excluded, especially in those with >1 involved lymph node).[2]

However, the MammaPrint 70-gene assay should not be used in patients with ER/PR-positive, HER2-negative (node-negative) breast cancer who have low clinical risk per MINDACT categorization; in those with ER/PR-positive, HER2-negative (node-positive) breast cancer who have one to three positive nodes and are at low clinical risk; or in those with HER2-positive breast cancer or triple-negative breast cancer.[2]

The PAM50 risk of recurrence (ROR) score may be used, in combination with other clinicopathologic variables, in patients with ER/PR-positive, HER2-negative (node-negative) breast cancer.[1] 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.

uPA and PAI-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.[1]

Neither the Mammostrat five-protein assay, nor the Immunohistochemistry 4 (IHC4), nor tumor-infiltrating lymphocytes should be used in patients with ER/PR-positive, HER2-negative (node-positive or node-negative) breast cancer; those with HER2-positive breast cancer; or patients with triple-negative breast cancer.[1]

Circulating tumor cells should not be used to guide decisions on adjuvant therapy.[1]

Protein encoded by the MKI67 gene should not be used to guide the selection of adjuvant chemotherapy.[1]

Neither CYP2D6 polymorphisms nor p27 expression determined by IHC should be used to guide the selection of adjuvant tamoxifen.[1]

Protein encoded by the MKI67 gene labeling index by IHC should not be used to guide the selection of adjuvant aromatase inhibitors.[1]

For patients with ER/PR-positive, HER2-negative (node-negative) breast cancer who have had 5 years of endocrine therapy without evidence of recurrence, clinicians should not use multiparameter gene expression or protein assays (Oncotype DX, EndoPredict, PAM50, BCI, or IHC4) to guide decisions on extended endocrine therapy.[1]

Clinicians should not use microtubule-associated protein Tau messenger (m)RNA expression or mRNA expression determined by IHC or HER1/epidermal growth-factor receptor expression by IHC to guide the selection of adjuvant taxanes.[1]

Clinicians should not use TOP2A gene amplification or TOP2A protein expression determined by IHC, nor should they use HER2 and TOP2A gene coamplification, CEP17 duplication, tissue inhibitor matrix metalloproteinase 1 (TIMP-1), Forkhead box protein P3 (FOXP3), or p53 to guide the selection of adjuvant anthracyclines selection.[1]

Clinicians should not use PTEN or soluble HER2 levels to guide the selection of trastuzumab in patients with HER2-positive breast cancer.[1]

For more information, please go to Breast Cancer, Breast Cancer and HER2, Adjuvant Therapy for Breast Cancer, and Breast Cancer Guidelines.

For more Clinical Practice Guidelines, please go to Guidelines.

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