Pathologist's health‐care value in the triage of Oncotype <scp>DX</scp><sup>®</sup> testing: a value‐based pathology study of tumour biology with outcomes

Dabbs, David J.; Clark, Beth Z.; Serdy, Kate M.; Oniśko, Agnieszka; Brufsky, Adam; Smalley, Sherie; Perkins, Stephen; Bhargava, Rohit

doi:10.1111/his.13690

Cited by 4 publications

(5 citation statements)

References 53 publications

(110 reference statements)

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“…Others have also reported significant cost savings with the use of MEs [ 37 , 38 , 40 ]. This should alarm integrated health systems (provider and insurer) that want to move toward value-based system [ 41 ].…”

Section: Discussionmentioning

confidence: 99%

The healthcare value of the Magee Decision Algorithm™: use of Magee Equations™ and mitosis score to safely forgo molecular testing in breast cancer

et al. 2020

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Magee Equations™ are multivariable models that can estimate oncotype DX® Recurrence Score, and Magee Equation 3 has been shown to have chemopredictive value in the neoadjuvant setting as a standalone test. The current study tests the accuracy of Magee Decision Algorithm™ using a large in-house database. According to the algorithm, if all Magee Equation scores are <18, or 18-25 with a mitosis score of 1, then oncotype testing is not required as the actual oncotype recurrence score is expected to be ≤25 (labeled "do not send"). If all Magee Equation scores are 31 or higher, then also oncotype testing is not required as the actual score is expected to be >25 (also "do not send"). All other cases could be considered for testing (labeled "send"). Of the 2196 ER+, HER2-negative cases sent for oncotype testing, 1538 (70%) were classified as "do not send" and 658 (30%) as "send". The classification accuracy in the "do not send" group was 95.1%. Of the 75 (4.9%) discordant cases (expected score ≤25 by decision algorithm but the actual oncotype score >25), 26 received endocrine therapy alone. None of these 26 patients experienced distant recurrence (average follow-up of 73 months). The Magee Decision Algorithm accurately identifies cases that will not benefit from oncotype testing. Such cases constitute~70% of the routine clinical oncotype requests, an estimated saving of $300,000 per 100 test requests. The occasional discordant cases (expected ≤25, but actual oncotype score >25) appears to have an excellent outcome on endocrine therapy alone.

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Section: Discussionmentioning

confidence: 99%

The healthcare value of the Magee Decision Algorithm™: use of Magee Equations™ and mitosis score to safely forgo molecular testing in breast cancer

et al. 2020

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“…Recently published studies implied that ordering of ODX test for every eligible ERþ/HER2-negative/lymph node-negative female patients with invasive breast carcinoma might not contribute to clinical management decisions. Some of these studies suggested that analysis of some of the clinicopathologic data available from pathology reports may select patients for which ODX test results were highly predictable and, therefore, the test could be safely and appropriately avoided [33,34]. We previously developed a "user friendly" nomogram/calculator [14] as a surrogate prediction model for the ODX score.…”

Section: Discussionmentioning

confidence: 99%

Nomogram update based on TAILORx clinical trial results - Oncotype DX breast cancer recurrence score can be predicted using clinicopathologic data

et al. 2019

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Objectives: Oncotype DX (ODX), 21-gene breast cancer (BC) assay, predicts risk of recurrence and benefits of addition of chemotherapy to hormonal therapy for early-stage BC. We previously published a nomogram/calculator that could predict ODX results without performing the test by using clinicopathologic characteristics of BC available from pathology reports. Patients with intermediate-risk (11e25) ODXRS (RS) were excluded from that nomogram. This update tests the predictive value of clinicopathologic variables for forecasting the ODXRS while including intermediate-risk-ODXRS patients and stratifying ODXRS based on recently published TAILORx clinical trial results (0e25 ¼ low-risk, 26 e100 ¼ high-risk-ODXRS; intermediate-risk-ODXRS belongs to the low-risk category). Material and methods: The nomogram was built on 65,754 ODX-tested ERþ/HER2-/lymph-node-negative patients with 6e50 mm tumor, captured by the National Cancer Data Base (NCDB) from 2010 to 2014.Five clinicopathologic variables (age, tumor size, grade, progesterone-receptor status (PR) and BChistologic type) were assessed with logistic regression to predict for a low-risk (0e25) or a high-risk (26e100) ODXRS. Results were validated on a separate 18,585 ODX-tested cohort from 2015. Results: Grade and PR were the highest significant predictors of both low-risk and high-risk-ODXRS, followed by histologic type, tumor size and age. The Receiver Operator Characteristic (ROC) curve showed strong statistical model for both low-risk and high-risk-ODXRS prediction outcomes (cindex ¼ 0.81). Conclusions: An updated nomogram is now developed/validated on the entire population of ODX-tested patients (84,339) captured by the NCDB. The nomogram/calculator, available on-line at the UTMCK/Shiny website (https://utgsm.shinyapps.io/OncotypeDXCalculator/), will continue serving as a surrogate for BC patients for which ODX testing is not affordable, available or necessary.

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“…First, we performed a detailed review of cases that showed ODX RS of ≤25 with a special focus on cases with RS of ≤10. We identified that up to a third of cancers with RS of ≤10 are of low-grade special subtype (such as tubular, cribriform, mucinous, classic lobular), and most others are enriched in high hormone receptor content and almost always have a mitosis score of 1 36 . This helped us design an algorithm based on MEs and mitosis score, which we prospectively applied to cases requested for clinical testing.…”

Section: Validation and Magee Decision Algorithmmentioning

confidence: 99%

“…We identified that up to a third of cancers with RS of ≤10 are of low-grade special subtype (such as tubular, cribriform, mucinous, classic lobular), and most others are enriched in high hormone receptor content and almost always have a mitosis score of 1. 36 This helped us design an algorithm based on MEs and mitosis score, which we prospectively applied to cases requested for clinical testing. The prospective value study included all clinical requests for ODX testing from the latter half of 2016 to the first quarter of 2018 at our center, resulting in a total of 205 cases.…”

Section: Validation and Magee Decision Algorithmmentioning

confidence: 99%

The Story of the Magee Equations: The Ultimate in Applied Immunohistochemistry

Bhargava

Dabbs

2022

Applied Immunohistochemistry &Amp; Molecular Morphology

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Magee equations (MEs) are a set of multivariable models that were developed to estimate the actual Oncotype DX (ODX) recurrence score in invasive breast cancer. The equations were derived from standard histopathologic factors and semiquantitative immunohistochemical scores of routinely used biomarkers. The 3 equations use slightly different parameters but provide similar results. ME1 uses Nottingham score, tumor size, and semiquantitative results for estrogen receptor (ER), progesterone receptor, HER2, and Ki-67. ME2 is similar to ME1 but does not require Ki-67. ME3 includes only semiquantitative immunohistochemical expression levels for ER, progesterone receptor, HER2, and Ki-67. Several studies have validated the clinical usefulness of MEs in routine clinical practice. The new cut-off for ODX recurrence score, as reported in the Trial Assigning IndividuaLized Options for Treatment trial, necessitated the development of Magee Decision Algorithm (MDA). MEs, along with mitotic activity score can now be used algorithmically to safely forgo ODX testing. MDA can be used to triage cases for molecular testing and has the potential to save an estimated $300,000 per 100 clinical requests. Another potential use of MEs is in the neoadjuvant setting to appropriately select patients for chemotherapy. Both single and multi-institutional studies have shown that the rate of pathologic complete response (pCR) to neoadjuvant chemotherapy in ER+/HER2-negative patients can be predicted by ME3 scores. The estimated pCR rates are 0%, <5%, 14%, and 35 to 40% for ME3 score <18, 18 to 25, >25 to <31, and 31 or higher, respectively. This information is similar to or better than currently available molecular tests. MEs and MDA provide valuable information in a time-efficient manner and are available free of cost for anyone to use. The latter is certainly important for institutions in resource-poor settings but is also valuable for large institutions and integrated health systems.

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Pathologist's health‐care value in the triage of Oncotype DX^® testing: a value‐based pathology study of tumour biology with outcomes

Cited by 4 publications

References 53 publications

The healthcare value of the Magee Decision Algorithm™: use of Magee Equations™ and mitosis score to safely forgo molecular testing in breast cancer

The healthcare value of the Magee Decision Algorithm™: use of Magee Equations™ and mitosis score to safely forgo molecular testing in breast cancer

Nomogram update based on TAILORx clinical trial results - Oncotype DX breast cancer recurrence score can be predicted using clinicopathologic data

The Story of the Magee Equations: The Ultimate in Applied Immunohistochemistry

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Pathologist's health‐care value in the triage of Oncotype DX® testing: a value‐based pathology study of tumour biology with outcomes

Cited by 4 publications

References 53 publications

The healthcare value of the Magee Decision Algorithm™: use of Magee Equations™ and mitosis score to safely forgo molecular testing in breast cancer

The healthcare value of the Magee Decision Algorithm™: use of Magee Equations™ and mitosis score to safely forgo molecular testing in breast cancer

Nomogram update based on TAILORx clinical trial results - Oncotype DX breast cancer recurrence score can be predicted using clinicopathologic data

The Story of the Magee Equations: The Ultimate in Applied Immunohistochemistry

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Pathologist's health‐care value in the triage of Oncotype DX^® testing: a value‐based pathology study of tumour biology with outcomes