The Rochester Modified Magee Algorithm (RoMMa): An Outcomes Based Strategy for Clinical Risk-Assessment and Risk-Stratification in ER Positive, HER2 Negative Breast Cancer Patients Being Considered for Oncotype DX(®) Testing

SIMPLE SUMMARY: As we move forward into the era of precision cancer medicine, we must consider the current state of the health care economy, as well patient access to quality health care. While multigene assays such as Oncotype DX(®) have certainly allowed for a more individualized approach to the risk-stratification of estrogen receptor positive, HER2 negative breast cancer patients, multigene assays are costly (Oncotype DX(®) costs more than USD $4000.00), and may not be accessible to breast cancer patients without adequate health insurance, particularly in more poverty stricken geographies around the world. These breast cancer patients also deserve opportunities for evidence-based clinical risk-assessment and risk-stratification. In this study we present data on the Rochester Modified Magee algorithm, a risk-stratification algorithm for breast cancer patients that could provide a significant cost savings for the health care system and also allow for clinical risk-assessment and risk-stratification when access to multigene testing is not readily available. ABSTRACT: Introduction: Multigene genomic profiling has become the standard of care in the clinical risk-assessment and risk-stratification of ER(+), HER2(−) breast cancer (BC) patients, with Oncotype DX(®) (ODX) emerging as the genomic profile test with the most support from the international community. The current state of the health care economy demands that cost-efficiency and access to testing must be considered when evaluating the clinical utility of multigene profile tests such as ODX. Several studies have suggested that certain lower risk patients can be identified more cost-efficiently than simply reflexing all ER(+), HER2(−) BC patients to ODX testing. The Magee equations(TM) use standard histopathologic data in a set of multivariable models to estimate the ODX recurrence score. Our group published the first outcome data in 2019 on the Magee equations(TM), using a modification of the Magee equations(TM) combined with an algorithmic approach—the Rochester Modified Magee algorithm (RoMMa). There has since been limited published outcome data on the Magee equations(TM). We present additional outcome data, with considerations of the TAILORx risk-stratification recommendations. Methods: 355 patients with an ODX recurrence score, and at least five years of follow-up or a BC recurrence were included in the study. All patients received either Tamoxifen or an aromatase inhibitor. None of the patients received adjuvant systemic chemotherapy. Results: There was no significant difference in the risk of recurrence in similar risk categories (very low risk, low risk, and high risk) between the average Modified Magee score and ODX recurrence score with the chi-square test of independence (p > 0.05) or log-rank test (p > 0.05). Using the RoMMa, we estimate that at least 17% of individuals can safely avoid ODX testing. Conclusion: Our study further reinforces that BC patients can be confidently stratified into lower and higher-risk recurrence groups using the Magee equations(TM). The RoMMa can be helpful in the initial clinical risk-assessment and risk-stratification of BC patients, providing increased opportunities for cost savings in the health care system, and for clinical risk-assessment and risk-stratification in less-developed geographies where multigene testing might not be available.