Multigene assays and molecular markers in breast cancer: systematic review of health economic analyses

Rouzier, Roman; Pronzato, P.; Chéreau, E.; Carlson, Josh J.; Hunt, Barnaby; Valentine, William J.

doi:10.1007/s10549-013-2559-1

Cited by 90 publications

(70 citation statements)

References 44 publications

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“…30,[47][48][49] However, the widespread use of this test has come into question recently, as the literature has suggested that certain cases might be risk stratified more costeffectively using histopathologic variables. [50][51][52][53][54] Our data support this.…”

Section: Modern Pathology (2015) 28 921-931mentioning

confidence: 99%

Use of modified Magee equations and histologic criteria to predict the Oncotype DX recurrence score

et al. 2015

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Oncotype DX (Genomic Health, Redwood City, CA, USA, current list price $4,350.00) is a multigene quantitative reverse transcription-polymerase chain reaction-based assay that estimates the risk of distant recurrence and predicts chemotherapy benefit for patients with estrogen receptor (ER)-positive breast cancers. Studies have suggested that standard histologic variables can provide similar information. Klein and Dabbs et al have shown that Oncotype DX recurrence scores can be estimated by incorporating standard histologic variables into equations (Magee equations). Using a simple modification of the Magee equation, we predict the Oncotype DX recurrence score in an independent set of 283 cases. The Pearson correlation coefficient (r) for the Oncotype DX and average modified Magee recurrence scores was 0.6644 (n = 283; Po 0.0001). 100% of cases with an average modified Magee recurrence score430 (n = 8) or an average modified Magee recurrence score o9 (with an available Ki-67, n = 5) would have been correctly predicted to have a high or low Oncotype DX recurrence score, respectively. 86% (38/44) of cases with an average modified Magee recurrence score ≤ 12, and 89% (34/38) of low grade tumors (NS o6) with an ER and PR ≥ 150, and a Ki-67 o 10%, would have been correctly predicted to have a low Oncotype DX recurrence score. Using an algorithmic approach to eliminate high and low risk cases, between 5% and 23% of cases would potentially not have been sent by our institution for Oncotype DX testing, creating a potential cost savings between $56,550.00 and $282,750.00. The modified Magee recurrence score along with histologic criteria may be a cost-effective alternative to the Oncotype DX in risk stratifying certain breast cancer patients. The information needed is already generated by many pathology laboratories during the initial assessment of primary breast cancer, and the equations are free. Breast cancer is the most common non-cutaneous cancer in women, and the second most frequent cause of cancer death among women. 1 Approximately 50% of breast cancer cases are estrogen receptor (ER)-positive. 2 A major challenge in the treatment planning for breast cancer is to identify those patients who are more likely to develop recurrence, so that the most appropriate therapeutic regimen can be provided. The decisions around systemic therapy in breast cancer have traditionally been based on combinations of clinical and histopathologic risk factors including measures of proliferation, 3 tumor size, 4 histologic grade, 5 as well as lymph node staging. 6 In addition, breast cancer biomarkers including ER, progesterone receptor (PR), and the human epidermal growth factor receptor-2 (HER-2), are routinely assessed to provide further prognostic information as well as to help identify subsets of patients who are appropriate for specific targeted therapies. 7-9 These prognostic markers are very useful for identifying the higher risk triple negative or HER-2-positive cases; however, it remains challenging to accurately assess individ...

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Section: Modern Pathology (2015) 28 921-931mentioning

confidence: 99%

Use of modified Magee equations and histologic criteria to predict the Oncotype DX recurrence score

et al. 2015

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“…15 Since the publication of the evidence review and EGAPP recommendation statement, several systematic reviews have been published addressing questions relating to the clinical utility and cost-effectiveness of Oncotype DX and MammaPrint. [16][17][18][19][20] On the basis of an overview of the findings of five of these systematic reviews 21 and additional published evidence, the EWG decided to prepare an updated version of its 2009 recommendation statement. This update focuses on the Oncotype DX test.…”

Section: Background and Clinical Context For The Recommendationmentioning

confidence: 99%

“…17,18 Two additional systematic reviews 19,20 summarized results from cost-effectiveness analyses reported in the included studies. Of these, only one assessed the quality of the included studies by criteria specific for economic analyses.…”

Section: Cost-effectivenessmentioning

confidence: 99%

“…Of these, only one assessed the quality of the included studies by criteria specific for economic analyses. 20 Furthermore, that review 20 included 18 cost-effectiveness studies for Oncotype DX, encompassing all 8 studies from the other review, 19 along with 10 additional studies. Quality ratings were high; however, it was noted that "the most common area where studies did not meet QHES criterion was explicit discussion of bias" and that "a number of analyses also failed to fully describe the model constructed and the assumptions used. "…”

Section: Cost-effectivenessmentioning

confidence: 99%

“…Quality ratings were high; however, it was noted that "the most common area where studies did not meet QHES criterion was explicit discussion of bias" and that "a number of analyses also failed to fully describe the model constructed and the assumptions used. " 20 Overall, use of the Oncotype RS to guide decisions on chemotherapy treatment was found to be costeffective from a health-payer perspective in a variety of healthcare settings in different countries (evaluation settings included the United States, Canada, the United Kingdom, Ireland, Japan, Singapore, Australia, Hungary, and Israel). 20,21 Most of these analyses used assumptions about chemotherapy benefit in different RS groups that are derived from the original EGAPP RECOMMENDATION STATEMENT studies on Oncotype and have yet to be confirmed by clinical trials.…”

Section: Cost-effectivenessmentioning

confidence: 99%

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Recommendations from the EGAPP Working Group: does the use of Oncotype DX tumor gene expression profiling to guide treatment decisions improve outcomes in patients with breast cancer?

2015

Genet Med

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Summary of Recommendations:The Evaluation of Genomic Applications in Practice and Prevention (EGAPP) Working Group found insufficient evidence to recommend for or against the use of Oncotype DX testing to guide chemotherapy treatment decisions in women with hormone receptor-positive, lymph node-negative, or lymph node-positive early breast cancer who are receiving endocrine therapy. This recommendation statement updates a 2009 EGAPP statement on the use of gene expression profiling tests in breast cancer. Evidence of clinical validity for Oncotype DX was confirmed as adequate. With regard to clinical utility, although there was evidence from prospective retrospective studies that the Oncotype DX test predicts benefit from chemotherapy, and there was adequate evidence that the use of Oncotype DX gene expression profiling in clinical practice changes treatment decisions regarding chemotherapy, no direct evidence was found that the use of Oncotype DX testing leads to improved clinical outcomes. Rationale:In women with early-stage invasive breast cancer, gene expression profiling is increasingly being used as an aid to estimate the likely benefit from chemotherapy treatment. In a previous recommendation statement, the EGAPP Working Group (EWG) found adequate evidence for clinical validity of some gene expression profiling tests in predicting distant disease recurrence in women with early-stage, hormone receptor-positive, lymph-node-negative breast cancer who are treated with tamoxifen, but insufficient evidence that use of these tests for decisions about chemotherapy treatment has clinical utility. The current recommendation statement updates these findings for Oncotype DX and extends them to the population of women with lymph node-positive disease, using evidence from recent systematic reviews and other sources. Analytic validity:The previous recommendation statement found that evidence was inadequate to enable quantitative determination of the analytic validity of Oncotype DX. Analytic validity was not reconsidered in the updated recommendation statement because there remains no gold-standard test for comparison. Clinical validity: The EWG found that new evidence published since the original evidence review supports the clinical validity of Oncotype DX in predicting risk of distant metastases in women with hormone receptor-positive, early-stage breast cancer that is either node-negative or node-positive. Clinical utility: No direct evidence was found that use of Oncotype DX tumor gene expression profiling to guide treatment decisions improves clinical outcomes in women with early breast cancer. There is indirect evidence, from prospective retrospective studies on archived tissue samples from randomized controlled trials, that the Oncotype DX test can predict benefit from chemotherapy. Large, prospective, randomized, controlled trials currently in progress may provide evidence of clinical utility. Contextual issues: Until definitive evidence for clinical utility is available, clinicians must decide on a case-by-cas...

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Association Between Use of the 21-Gene Recurrence Score Assay and Receipt of Chemotherapy Among Medicare Beneficiaries With Early-Stage Breast Cancer, 2005-2009

Dinan

Reed

et al. 2015

JAMA Oncol

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Multigene assays and molecular markers in breast cancer: systematic review of health economic analyses

Cited by 90 publications

References 44 publications

Use of modified Magee equations and histologic criteria to predict the Oncotype DX recurrence score

Use of modified Magee equations and histologic criteria to predict the Oncotype DX recurrence score

Recommendations from the EGAPP Working Group: does the use of Oncotype DX tumor gene expression profiling to guide treatment decisions improve outcomes in patients with breast cancer?

Association Between Use of the 21-Gene Recurrence Score Assay and Receipt of Chemotherapy Among Medicare Beneficiaries With Early-Stage Breast Cancer, 2005-2009

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