Real-world implementation and cost impact analysis of Oncotype DX testing in early-stage breast cancer

BACKGROUND: The decision on appropriate adjuvant treatment for patients with hormone receptor-positive (HR+) and human epidermal growth factor receptor 2 -negative (HER2-) early breast cancer (eBC) is sometimes challenging. Genomic assays have improved individualized treatment decisions by providing information on the genomic risk of tumors. The Oncotype DX assay (ODX) is both prognostic and predictive of chemotherapy benefit. This study aimed to evaluate the implementation process of the ODX into clinical practice, the impact of ODX on adjuvant chemotherapy treatment decisions and conduct a cost impact analysis. PATIENTS AND METHODS: A retrospective study at Tampere University Hospital included 129 patients with HR + , HER2- eBC tested with ODX between September 2021 and September 2023. Treatment decisions as well as adjuvant chemotherapy (CT) costs, associated health provider costs, and societal costs were projected. RESULTS: ODX testing significantly altered CT recommendations by reducing unnecessary CT for 73% of the study patients. With ODX testing, the cost impact analysis revealed partial cost savings for the health care provider due to reduced CT administration. From a societal perspective, the use of ODX resulted in substantial savings largely attributed to the maintenance of work productivity among working-aged and employed patients. CONCLUSION: This study highlights the importance of streamlined testing processes and the need for clinician training in interpreting test results in a real-world setting. In addition, the findings underscore the role of ODX in enhancing personalized treatment in HR + , HER2- eBC while reducing overtreatment. The cost analysis indicates substantial cost savings with ODX testing.