The Oncotype Dx Assay in ER-Positive, HER2-Negative Breast Cancer Patients: A Real Life Experience from a Single Cancer Center.

Objective: To determine the influence of the Oncotype Dx assay on the treatment of patients with Estrogen Receptor (ER)-positive, Human Epidermal Growth Factor Receptor 2 (HER2)-negative, axillary lymph node-negative or micrometastatic carcinoma of the breast in a single cancer center. In addition, patients with intermediate Oncotype Dx recurrence scores were analyzed to assess the factors influencing therapeutic decisions for adjuvant chemotherapy.

Materials And Methods: Data from medical records of women diagnosed with carcinoma of the breast and qualified for the Oncotype Dx assay were extracted (OncoDx cohort). Patient demographic and cancer characteristics, genomic report, and course of treatment data, including survival outcomes and treatment decision-making, were analyzed. A matched cohort of patients with similar tumor stage and biology (ER-positive, HER2-negative) from the era before the introduction of the Oncotype Dx assay was analyzed for comparison (pre-OncoDx cohort).

Results: Two hundred and one patients were included in the OncoDx cohort and one hundred and sixty patients were included in the pre-OncoDx cohort. Oncotype Dx recurrence score (RS) was low (<11) in fifty-six patients (28%), intermediate (11-25) in one hundred and twenty-three patients (61.5%) and high (>25) in twenty one patients (10.5%). Demographic and cancer clinicopathologic characteristics between OncoDx and pre-OncoDx cohorts were similar. Overall, 10.9% of the patients in the OncoDx cohort received adjuvant chemotherapy, versus 23.8% of the patients in the pre-OncoDx cohort (Fisher exact p=0.003). Fewer patients were recommended adjuvant chemotherapy in the OncoDx era compared to the pre-OncoDx era (17.9% vs 30.6%, respectively, Fisher exact p=0.006). The decision to recommend chemotherapy within the intermediate-risk cohort was influenced by the patient's RS. The mean RS of patients in the intermediate-risk cohort who did not receive chemotherapy was 21.5 while the score of those that received chemotherapy was 24.6 (p=0.000). The series confirmed excellent PFS and OS for both OncoDx and pre-OncoDx cohorts.

Conclusion: This single cancer center analysis confirms the avoidance of chemotherapy in the great majority of patients with early ER-positive, HER2-negative, lymph node-negative or micrometastatic carcinoma of the breast since the introduction of the Oncotype Dx assay. A higher recurrence risk score within the intermediate group may influence the decision for chemotherapy inclusion in the adjuvant treatment plan. A lower PR percentage by IHC and higher grade may predict higher Oncotype Dx scores.