ASCO Guideline on Use of Biomarkers to Guide Decisions on Adjuvant Systemic Therapy in Early-Stage Invasive Breast Cancer


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Although several tests are now recommended in the guidelines, only one needs to be used to guide therapy for an individual patient.

—Lyndsay N. Harris, MD, and colleagues

As reported in the Journal of Clinical Oncology by Lyndsay N. Harris, MD, and colleagues,1 ASCO has released a clinical practice guideline on the use of biomarkers in addition to estrogen receptor/progesterone receptor and HER2 status to guide decisions on adjuvant systemic therapy in women with early-stage invasive breast cancer. Guideline development was based on expert panel review of systematic reviews, meta-analyses, randomized controlled trials, prospective-retrospective studies, and prospective comparative observational studies published from 2006 through 2014.

Recommendations are summarized here. The type of recommendation, evidence quality, and strength of recommendation, in that order, are shown in italics.

Clinical Question 1

The guideline addressed the question: “For women with early-stage invasive breast cancer and with known estrogen receptor/progesterone receptor and HER2 status, which other biomarkers have demonstrated clinical utility to guide decisions on the need for adjuvant systemic therapy?”

Oncotype DX

If a patient has estrogen receptor/progesterone receptor–positive, HER2-negative, node-negative breast cancer, the Oncotype DX 21-gene recurrence score may be used to guide decisions on adjuvant systemic therapy (evidence based, high, strong).

It should not be used in patients with estrogen receptor/progesterone receptor–positive, HER2-negative, node-positive disease (evidence based, intermediate, moderate).

It should not be used in patients with HER2-positive or triple-negative disease (informal consensus, insufficient, strong).

EndoPredict

If a patient has estrogen receptor/progesterone receptor–positive, HER2-negative, node-negative breast cancer, the EndoPredict 12-gene recurrence score may be used to guide decisions on adjuvant systemic therapy (evidence based, intermediate, moderate).

It should not be used in patients with estrogen receptor/progesterone receptor–positive, HER2-negative, node-positive disease (evidence based, insufficient, ­moderate).

It should not be used in patients with HER2-positive or triple-negative disease (informal consensus, insufficient, strong).

MammaPrint

If a patient has estrogen receptor/progesterone receptor–positive, HER2-negative (node-positive or node-negative) breast cancer, the MammaPrint 70-gene assay should not be used to guide decisions on adjuvant systemic therapy (evidence based, intermediate, moderate).

It should not be used in patients with HER2-positive disease (informal consensus, low, moderate).

It should not be used in patients with triple-negative breast cancer (informal consensus, insufficient, strong).

PAM50 Risk of Recurrence Score

If a patient has estrogen receptor/progesterone receptor–positive, HER2-negative, node-negative breast cancer, the PAM50 risk of recurrence score may be used in conjunction with other clinicopathologic variables to guide decisions on adjuvant systemic therapy (evidence based, high, strong).

It should not be used in patients with estrogen receptor/progesterone receptor–positive, HER2-negative, node-positive disease (evidence based, intermediate, ­moderate).

It should not be used in patients with HER2-positive breast cancer (informal consensus, insufficient, strong).

It should not be used in patients with triple-negative breast cancer (informal consensus, insufficient, strong).

Breast Cancer Index

If a patient has estrogen receptor/progesterone receptor–positive, HER2-negative, node-negative breast cancer, the Breast Cancer Index may be used to guide decisions on adjuvant systemic therapy (evidence based, intermediate, moderate).

It should not be used in patients with estrogen receptor/progesterone receptor–positive, HER2-negative, node-positive disease (informal consensus, insufficient, strong).

It should not be used in patients with HER2-positive disease (informal consensus, insufficient, strong).

Mammostrat

If a patient has estrogen receptor/progesterone receptor–positive, HER2-negative (node-positive or node-negative) breast cancer, the Mammostrat 5-protein assay should not be used (evidence based, intermediate, moderate).

It should not be used in patients with HER2-positive or triple-negative breast cancer (informal consensus, insufficient, strong).

Immunohistochemistry 4

If a patient has estrogen receptor/progesterone receptor–positive, HER2-negative (node-positive or node-negative) breast cancer, immunohistochemistry 4 (IHC4) should not be used (evidence based, intermediate, moderate).

It should not be used in patients with HER2-positive or triple-negative breast cancer (informal consensus, insufficient, strong).

Urokinase Plasminogen Activator and Plasminogen Activator Inhibitor Type 1

If a patient has estrogen receptor/progesterone receptor–positive, HER2-negative, node-negative breast cancer, urokinase plasminogen activator and plasminogen activator inhibitor type 1 may be used (evidence based, high, weak).

They should not be used in patients with HER2-positive or triple-negative breast cancer (informal consensus, insufficient, weak).

Circulating Tumor Cells

Circulating tumor cells should not be used (evidence based, intermediate, strong).

Tumor-Infiltrating Lymphocytes

If a patient has estrogen receptor/progesterone receptor–positive, HER2-negative (node-positive or node-negative) breast cancer, tumor-infiltrating lymphocytes should not be used (informal consensus, insufficient, strong).

The marker should not be used in patients with HER2-positive or triple-negative breast cancer (evidence based, intermediate, strong).

Protein Encoded by MKI67 Gene 

Protein encoded by the MKI67 gene–labeling index by immunohistochemistry (IHC) should not be used (evidence based, intermediate, moderate).

Extended Endocrine Therapy

If a patient has estrogen receptor/progesterone receptor–positive, HER2-negative (node-negative) breast cancer and has had 5 years of endocrine therapy without evidence of recurrence, multiparameter gene expression or protein assays (Oncotype DX, EndoPredict, PAM50, Breast Cancer Index, or IHC4) should not be used to guide decisions on extended endocrine therapy (evidence based, intermediate, moderate).

Clinical Question 2

The guideline also addressed the question: “For women with early-stage invasive breast cancer and with known estrogen receptor/progesterone receptor and HER2 status, which additional biomarkers have demonstrated clinical utility to guide the choice of specific drugs or regimens for adjuvant systemic therapy?”

Tamoxifen

CYP2D6 polymorphisms should not be used to guide adjuvant endocrine therapy selection (evidence based, intermediate, moderate).

The expression of p27 by immunohistochemistry should not be used to guide adjuvant endocrine therapy selection (informal consensus, low, strong).

Aromatase Inhibitors

Protein encoded by the MKI67 gene–labeling index by immunohistochemistry should not be used to guide adjuvant endocrine therapy (evidence based, intermediate, moderate).

Taxanes

Microtubule-associated protein Tau mRNA expression or mRNA expression by immunohistochemistry should not be used to guide adjuvant chemotherapy selection (evidence based, intermediate, ­moderate).

HER1/epidermal growth factor receptor expression by immunohistochemistry should not be used to guide adjuvant chemotherapy selection (evidence based, low, moderate).

Anthracyclines

TOP2A gene amplification or ­TOP2A protein expression by immunohistochemistry should not be used to guide adjuvant chemotherapy selection (evidence based, high, moderate).

HER2 and TOP2A gene coamplification, CEP17 duplication, TIMP-1, FOXP3, or p53 should not be used to guide adjuvant chemotherapy selection (evidence based, intermediate, moderate).

Trastuzumab

If a patient has HER2-positive breast cancer, PTEN should not be used to guide adjuvant therapy selection (evidence based, intermediate, ­moderate).

If a patient has HER2-positive breast cancer, soluble HER2 levels should not be used to guide the selection of the type of adjuvant therapy (evidence based, low, ­moderate). ■

Disclosure: For full disclosures of the study authors, visit www.jco.ascopubs.org.

Reference

1. Harris LN, Ismaila N, McShane LM, et al: Use of biomarkers to guide decisions on adjuvant systemic therapy for women with early-stage invasive breast cancer: American Society of Clinical Oncology clinical practice guideline. J Clin Oncol 34:1134-1150, 2016.


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