Gene expression profiling and expanded immunohistochemistry tests to guide the use of adjuvant chemotherapy in breast cancer management: a systematic review and cost-effectiveness analysis

Ward, Sue; Scope, Alison; Rafia, Rachid; Pandor, Abdullah; Harnan, S; Evans, Philippa; Wyld, Lynda

doi:10.3310/hta17440

Cited by 87 publications

(128 citation statements)

References 132 publications

(341 reference statements)

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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%

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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Section: Background and Clinical Context For The Recommendationmentioning

confidence: 99%

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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“…The manufacturer (http://www.genomichealth.com) has since expanded the indications for use to node-positive disease and ductal carcinoma in situ, based on retrospective testing of archival samples from those patient groups. Health technology assessments in the United States 4 , the United Kingdom 5 , and Canada 6 have reported that, although there is evidence of the test's prognostic value, the direct evidence is insufficient to determine its predictive value (clinical utility) in determining which patients are likely to respond to chemotherapy [4][5][6] .…”

Section: Introductionmentioning

confidence: 99%

Uptake of a 21-Gene Expression Assay in Breast Cancer Practice: Views of Academic and Community-Based Oncologists

et al. 2017

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Purpose Advances in personalized medicine have produced novel tests and treatment options for women with breast cancer. Relatively little is known about the process by which such tests are adopted into oncology practice. The objectives of the present study were to understand the experiences of medical oncologists with multigene expression profile (gep) tests, including their adoption into practice in early-stage breast cancer, and the perceptions of the oncologists about the influence of test results on treatment decision-making. MethodsWe conducted a qualitative descriptive study involving interviews with medical oncologists from academic and community cancer centres or hospitals in 8 communities in Ontario. A 21-gene breast cancer assay was used as the example of gep testing. Qualitative analytic techniques were used to identify the main themes. ResultsOf 28 oncologists who were approached, 21 (75%) participated in the study [median age: 43 years; 12 women (57%)]. Awareness and knowledge of gep testing were derived from several sources: international scientific meetings, participation in clinical studies, discussions with respected colleagues, and manufacturer-sponsored meetings. Oncologists observed that incorporating gep testing into their clinical practice resulted in several changes, including longer consultation times, second visits, and taking steps to minimize treatment delays. Oncologists expressed divergent opinions about the strength of evidence and added value of gep testing in guiding treatment decisions.Conclusions Incorporation of gep testing into clinical practice in early-stage breast cancer required oncologists to make changes to their usual routines. The opinions of oncologists about the quality of evidence underpinning the test affected how much weight they gave to test results in treatment decision-making.

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“…A 2008 UK survey reported that only 18.8% of radical breast radiotherapy cases were treated with IMRT [33]. The estimated cost for Ki-67 testing was £112 per case [34]; hence, the estimated saving in the UK per year could be over £14 million [5236 Â (2846e112/0.5)].…”

Section: Discussionmentioning

confidence: 99%

Omission of Breast Radiotherapy in Low-risk Luminal A Breast Cancer: Impact on Health Care Costs

et al. 2016

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Aims: The economic burden of cancer care is substantial, including steep increases in costs for breast cancer management. There is mounting evidence that women age ! 60 years with grade I/II T1N0 luminal A (ER/PRþ, HER2e and Ki67 13%) breast cancer have such low local recurrence rates that adjuvant breast radiotherapy might offer limited value. We aimed to determine the total savings to a publicly funded health care system should omission of radiotherapy become standard of care for these patients. Materials and methods: The number of women aged ! 60 years who received adjuvant radiotherapy for T1N0 ERþ HER2e breast cancer in Ontario was obtained from the provincial cancer agency. The cost of adjuvant breast radiotherapy was estimated through activity-based costing from a public payer perspective. The total saving was calculated by multiplying the estimated number of luminal A cases that received radiotherapy by the cost of radiotherapy minus Ki-67 testing. Results: In 2010, 748 women age ! 60 years underwent surgery for pT1N0 ERþ HER2e breast cancer; 539 (72%) underwent adjuvant radiotherapy, of whom 329 were estimated to be grade I/II luminal A subtype. The cost of adjuvant breast radiotherapy per case was estimated at $6135.85; the cost of Ki-67 at $114.71. This translated into an annual saving of about $2.0million if radiotherapy was omitted for all low-risk luminal A breast cancer patients in Ontario and $5.1million across Canada. Conclusion: There will be significant savings to the health care system should omission of radiotherapy become standard practice for women with low-risk luminal A breast cancer.

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Gene expression profiling and expanded immunohistochemistry tests to guide the use of adjuvant chemotherapy in breast cancer management: a systematic review and cost-effectiveness analysis

Cited by 87 publications

References 132 publications

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?

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?

Uptake of a 21-Gene Expression Assay in Breast Cancer Practice: Views of Academic and Community-Based Oncologists

Omission of Breast Radiotherapy in Low-risk Luminal A Breast Cancer: Impact on Health Care Costs

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