Clinicopathological Factors Associated with Oncotype DX Risk Group in Patients with ER+/HER2- Breast Cancer

SIMPLE SUMMARY: Oncotype DX (ODX) is a gene assay that can predict the recurrence risk in patients with early breast cancer. We aimed to evaluate clinicopathological factors that can predict the ODX risk group as an alternative to this expensive assay. A total of 547 patients with estrogen receptor-positive, human epidermal growth factor 2-negative, and lymph node-negative breast cancer who underwent ODX testing were retrospectively included in this study; these were categorized into risk groups based on their age and recurrence scores. We identified that the ODX risk groups were significantly associated with histologic grade, progesterone receptor expression, Ki-67, and p53 expression in patients aged ≤50 years and with the tumor size, Ki-67, and p53 expression in patients aged >50 years. These clinicopathological factors, which differ with age, can be used to predict the ODX risk group and decide on the need for adjuvant chemotherapy. ABSTRACT: Oncotype DX (ODX), a 21-gene assay, predicts the recurrence risk in early breast cancer; however, it has high costs and long testing times. We aimed to identify clinicopathological factors that can predict the ODX risk group and serve as alternatives to the ODX test. This retrospective study included 547 estrogen receptor-positive, human epidermal growth factor receptor 2-negative, and lymph node-negative breast cancer patients who underwent ODX testing. Based on the recurrence scores, three ODX risk categories (low: 0–15, intermediate: 16–25, and high: 26–100) were established in patients aged ≤50 years (n = 379), whereas two ODX risk categories (low: 0–25 and high: 26–100) were established in patients aged >50 years (n = 168). Factors selected for analysis included body mass index, menopausal status, type of surgery, and pathological and immunohistochemical features. The ODX risk groups showed significant association with histologic grade (p = 0.0002), progesterone receptor expression (p < 0.0001), Ki-67 (p < 0.0001), and p53 expression (p = 0.023) in patients aged ≤50 years. In patients aged >50 years, tumor size (p = 0.022), Ki-67 (p = 0.001), and p53 expression (p = 0.001) were significantly associated with the risk group. Certain clinicopathological factors can predict the ODX risk group and enable decision-making on adjuvant chemotherapy; these factors differ according to age.