Abstract
The skyrocketing cost of health‐care demands that we question when to use multigene assay testing in the planning of treatment for breast cancer patients. A previously published algorithmic model gave recommendations for which cases to send out for Oncotype DX® (ODX) testing. This study is a multi‐institutional validation of that algorithmic model in 620 additional estrogen receptor positive breast cancer cases, with outcome data on 310 cases, named in this study as the Rochester Modified Magee algorithm (RoMMa). RoMMa correctly predicted 85% (140/164) and 100% (17/17) of cases to have a low‐ or high‐risk ODX recurrence score, respectively, consistent with the original publication. Applying our own risk stratification criteria, in patients who received appropriate hormonal therapy, only one of the 45 (2.0%) patients classified as low risk by our original algorithm have been associated with a breast cancer recurrence over 5‐10 years of follow‐up. Eight of 116 (7.0%) patients classified as low risk by ODX have been associated with a breast cancer recurrence with up to 11 years of follow‐up. In addition, 524 of 537 (98%) cases from our total population (n = 903) with an average modified Magee score ≤18 had an ODX recurrence score <26. Patients with an average modified Magee score ≤18 or >30 may not need to be sent out for ODX testing. By avoiding these cases sending out for ODX testing, the potential cost savings to the health‐care system in 2018 are estimated to have been over $100,000,000.
Highlights
The evolving era of precision medicine demands both cost‐ efficient and cost‐effective strategies for diagnostic treatment algorithms
A Pearson correlation shows a significant correlation (P < 0.0001) between the original test population and the validation population when comparing the percentage of cases in both a particular Magee score group and its correlating Oncotype DX® (ODX) risk group (Figure S2 Table 3 and Table S3).The chi‐squared (χ2) test of independence showed no significant difference between the observed frequencies in the original
Our results suggest that the likelihood of breast cancer recurrence with an average modified Magee score ≤12 is comparable with an ODX recurrence score (ODXRS)
Summary
The evolving era of precision medicine demands both cost‐ efficient and cost‐effective strategies for diagnostic treatment algorithms. Challenges remain in accurately assessing which strategies are more cost‐effective for identifying hormone receptor‐positive breast cancer patients who will benefit from systemic chemotherapy. In a majority of these studies supporting the cost‐effectiveness of ODX, clinical characteristics commonly used to make chemotherapy decisions (ie, tumor size and grade) were not incorporated into simulation modeling. As such, these “supportive” studies might not reflect actual clinical practice.[18]
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