Quality Assurance Model for Breast Cancer Prognostication Using the Modified Magee Equations.

ABSTRACT

CONTEXT.­ The Oncotype DX recurrence score (RS) is a widely used test that provides prognostic information on the likelihood of disease recurrence and predictive information on the benefit of chemotherapy in early-stage, hormone receptor-positive breast cancer. Despite its widespread use, quality assurance of the RS does not receive the same level of scrutiny as other tests, such as human epidermal growth factor receptor 2 (HER2) immunohistochemistry. OBJECTIVE.­ To use modified Magee equations to calculate Magee score (MS) as a quality check of RS. DESIGN.­ The MS is an easily accessible prognostic model that uses histopathologic and immunohistochemical criteria. We identified cases where the RS and MS differed by 10 points or more or were in different risk categories. These instances were considered significant discordances. MS was presented along with RS at multidisciplinary tumor boards and all discrepancies were discussed to determine clinical significance and appropriate next steps. RESULTS.­ Twenty-five of 155 cases (16.1%) had discrepancies between RS and MS. Of these 25 cases, 3 (12%) had problems with either the RS or the histopathologic interpretation. Among the cases with concordant RS and MS, no RS or interpretive problems were identified. CONCLUSIONS.­ Use of the MS as a quality control check for the RS can help ensure appropriate treatment decisions in breast cancer patients. Pathologists can play a key role in ensuring the quality of molecular-based prognostic scores by using histopathologic models to ensure accurate risk stratification and improve clinical outcomes.