Abstract P2-05-15: Oncotype DX Breast Recurrence Score®: Real-life utilization among node positive patients in Ontario

Abstract

Abstract Aims: The 21-gene Oncotype DX (ODX) Recurrence Score (RS) has been extensively validated to predict the risk of distant recurrence and the magnitude of response to hormone and chemotherapy in patients with ER+ N0 and N+ (up to 3 positive nodes) HER2- early stage breast cancer. Outcomes data from multiple large studies further confirm the assays clinical validity and utility. The test is currently reimbursed in Ontario for N0 but not for N1 patients. In 2016, a market access program has been initiated to address lack of data in current clinical practice in Ontario among N1 patients. It collects data assessing the real-life use of the test in Ontario and its impact on treatment decision. This analysis presents the interim analysis until end of May 2017. Methods : The program allows for prospective data collection in key breast cancer centers in Ontario. Through an online dedicated platform patient data are collected including classical pathological and clinical parameters (e.g. histology, tumor grade and size, ER, PR, and HER2 status), patients age, ODX Recurrence Score results and recommended treatment both before and after the test results have been reported. Results: A total of 7 qualified breast cancer centers or network of centers participated in the program and collected 90 cases so far. Study results demonstrated that ODX is used among a wide variety of patients profiles: 28% G1, 58% G2 and 14% of G3, 18% pre-, 12% peri- & 69% are post-menopausal, 20% are aged 40-49, 24% are 50-59, 29% are 60-69 and 26% are 70 and older, 3% tumor are <1cm, 38% are 1-<2cm, 52% are 2-<5cm and 7% tumor size are >5cm. RS distribution is the following: <18 (67%), 18-30 (30%) and >30 (3%). In addition, pre-ODX 90% of patients had a treatment recommendation for chemo-hormonotherapy (CT-HT). Post-testing, the number of patients recommended CT-HT decreased to 36%, highlighting that the test reduces unnecessary use of CT. In fact, the ODX led to an overall 54% net reduction in chemotherapy. Conclusions: This real-life survey confirms that ODX provides critical information beyond clinical and pathological criteria. The assay changes treatment decisions among N+ patients in Ontario, sparing CT which could result in potential savings to the healthcare system. Citation Format: Richardson R, Macchiusi A, Bhasin A, Takizawa C. Oncotype DX Breast Recurrence Score®: Real-life utilization among node positive patients in Ontario [abstract]. In: Proceedings of the 2017 San Antonio Breast Cancer Symposium; 2017 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2018;78(4 Suppl):Abstract nr P2-05-15.