Identifying Clinicopathological Factors Associated with Oncotype DX® 21-Gene Recurrence Score: A Real-World Retrospective Cohort Study of Breast Cancer Patients in Quebec City, Canada

Abstract

Gene expression profiling tests such as the Oncotype DX (ODX) 21-gene recurrence score (RS) assay is increasingly used in clinical practice to predict the risk of recurrence and support treatment planning for early-stage breast cancer (BC). However, this test has some disadvantages such as a high cost and a long turnaround time to get results, which may lead to disparities in access. We aim to identify clinicopathological factors associated with ODX RS in women with early-stage BC. We conducted a retrospective cohort study of women identified in the medical database of the Deschênes-Fabia Breast Disease Center of Quebec City University, Canada. Our sample consists of 425 women diagnosed with early-stage BC who have obtained an ODX RS between January 2011 and April 2015. The ODX RS has been categorized into three levels as originally defined: low (0–17), intermediate (18–30), and high (>30). The mean RS was 17.8 (SD = 9.2). Univariate analyses and multinomial logistic regressions were performed to identify factors associated with intermediate and high RS compared with low RS. A total of 237 (55.8%) patients had low RS, 148 (34.8%) had intermediate RS, and 40 (9.4%) had high RS. Women with progesterone receptor (PR)-negative (ORs ranging from 3.51 to 10.34) and histologic grade II (ORs ranging from 3.16 to 23.04) tumors were consistently more likely to have intermediate or high RS than low RS. Similar patterns of associations were observed when the RS was categorised using redefined thresholds from (i.e., from the TAILORx study or dichotomized). This study provides evidence suggesting that histologic grade and PR status are predictive factors for intermediate or high RS in women with early-stage BC. If these results are confirmed in future studies, considering these clinicopathological factors could spare women the need to get such a test before the beginning of a possible adjuvant therapy. This option could be considered in settings where the cost of testing is an issue.