Key Points
➤ 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.
➤ 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 Oncotype DX, MammaPrint,
EndoPredict, PAM50, Breast Cancer Index, and urokinase plasminogen
activator and plasminogen activator inhibitor type 1 in specific subgroups
of breast cancer.
➤ No biomarker except for estrogen receptor, progesterone receptor, and
human epidermal growth factor receptor 2 was found to guide choices of
specific treatment regimens.
➤ Treatment decisions should also consider disease stage, comorbidities,
and patient preferences.
Diagnosis
For patients who present with a hormone receptor positive, HER2
not overexpressed, axillary node negative early breast cancer:
Oncotype DX
➤ For patients older than 50 and whose tumors have Oncotype DX recurrence
scores <26, and for patients ≤50 whose tumors have Oncotype DX recurrence
scores <16, there is little to no benefit from chemotherapy. Clinicians may
offer endocrine therapy alone. (Strong Recommendation; EB-H)
➤ For patients 50 years of age or younger with Oncotype DX recurrence
scores of 16 to 25, clinicians may offer chemoendocrine therapy.
(Moderate Recommendation; EB-I)
➤ Patients with Oncotype DX recurrence scores >30 should be considered
candidates for chemoendocrine therapy. (Strong Recommendation; EB-H)
➤ Based on Expert Panel consensus, oncologists may offer chemoendocrine
therapy to patients with Oncotype DX scores of 26 to 30. (Moderate
Recommendation; IC-Ins)
