Key Points
Î In an era of great interest in personalized, precision medicine, the role of
tumor biomarker assays in guiding clinical care has taken on even greater
importance than in the past.
Î In addition to estrogen and progesterone receptors and human epidermal
growth factor receptor 2 (HER2), the panel found sufficient evidence
of clinical utility for the biomarker assays MammaPrint, Oncotype DX,
EndoPredict, PAM50, Breast Cancer Index, and urokinase plasminogen
activator and plasminogen activator inhibitor type 1 in specific subgroups
of breast cancer.
Î No biomarker except for estrogen receptor, progesterone receptor, and
human epidermal growth factor receptor 2 was found to guide choices of
specific treatment regimens.
Î Treatment decisions should also consider disease stage, comorbidities, and
patient preferences.
Diagnosis
Early-Stage Invasive Breast Cancer with Known ER/PgR and
HER2 Status
Oncotype DX
Î If a patient has ER/PgR-positive, HER2-negative (node-negative) breast
cancer, the clinician may use the 21-gene recurrence score (RS; Oncotype
DX; Genomic Health, Redwood City, CA) to guide decisions on adjuvant
systemic chemotherapy. (Strong Recommendation; EB-H)
Î If a patient has ER/PgR-positive, HER2-negative (node-positive) breast
cancer, the clinician should NOT use the 21-gene RS to guide decisions on
adjuvant systemic chemotherapy. (Moderate Recommendation; EB-I)
Î If a patient has HER2-positive breast cancer or triple negative (TN) breast
cancer, the clinician should NOT use the 21-gene triple negative (RS) to
guide decisions on adjuvant systemic therapy. (Strong Recommendation;
IC-Ins)
