Journal Article
. 2020 Apr; 20(10):1-234.

Gene Expression Profiling Tests for Early-Stage Invasive Breast Cancer: A Health Technology Assessment

Ontario Health (Quality)  
  • PMID: 32284770
  •     195 References
  •     7 citations

Abstract

Background: Breast cancer is a disease in which cells in the breast grow out of control. They often form a tumour that may be seen on an x-ray or felt as a lump.Gene expression profiling (GEP) tests are intended to help predict the risk of metastasis (spread of the cancer to other parts of the body) and to identify people who will most likely benefit from chemotherapy. We conducted a health technology assessment of four GEP tests (EndoPredict, MammaPrint, Oncotype DX, and Prosigna) for people with early-stage invasive breast cancer, which included an evaluation of effectiveness, safety, cost effectiveness, the budget impact of publicly funding GEP tests, and patient preferences and values.

Methods: We performed a systematic literature search of the clinical evidence. We assessed the risk of bias of each included study using either the Cochrane Risk of Bias tool, Prediction model Risk Of Bias ASsessment Tool (PROBAST), or Risk of Bias Assessment tool for Non-randomized Studies (RoBANS), depending on the type of study and outcome of interest, and the quality of the body of evidence according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria. We also performed a literature survey of the quantitative evidence of preferences and values of patients and providers for GEP tests.We performed an economic evidence review to identify published studies assessing the cost-effectiveness of each of the four GEP tests compared with usual care or with one another for people with early-stage invasive breast cancer. We adapted a decision-analytic model to compare the costs and outcomes of care that includes a GEP test with usual care without a GEP test over a lifetime horizon. We also estimated the budget impact of publicly funding GEP tests to be conducted in Ontario, compared with funding tests conducted through the out-of-country program and compared with no funding of tests in any location.To contextualize the potential value of GEP tests, we spoke with people who have been diagnosed with early-stage invasive breast cancer.

Results: We included 68 studies in the clinical evidence review. Within the lymph-node-negative (LN-) population, GEP tests can prognosticate the risk of distant recurrence (GRADE: Moderate) and may predict chemotherapy benefit (GRADE: Low). The evidence for prognostic and predictive ability (ability to indicate the risk of an outcome and ability to predict who will benefit from chemotherapy, respectively) was lower for the lymph-node-positive (LN+) population (GRADE: Very Low to Low). GEP tests may also lead to changes in treatment (GRADE: Low) and generally may increase physician confidence in treatment recommendations (GRADE: Low).Our economic evidence review showed that GEP tests are generally cost-effective compared with usual care.Our primary economic evaluation showed that all GEP test strategies were more effective (led to more quality-adjusted life-years [QALYs]) than usual care and can be considered cost-effective below a willingness-to-pay of $20,000 per QALY gained. There was some uncertainty in our results. At a willingness-to-pay of $50,000 per QALY gained, the probability of each test being cost-effective compared to usual care was 63.0%, 89.2%, 89.2%, and 100% for EndoPredict, MammaPrint, Oncotype DX, and Prosigna, respectively.Sensitivity analyses showed our results were robust to variation in subgroups considered (i.e., LN+ and premenopausal), discount rates, age, and utilities. However, cost parameter assumptions did influence our results. Our scenario analysis comparing tests showed Oncotype DX was likely cost-effective compared with MammaPrint, and Prosigna was likely cost-effective compared with EndoPredict. When the GEP tests were compared with a clinical tool, the cost-effectiveness of the tests varied. Assuming a higher uptake of GEP tests, we estimated the budget impact to publicly fund GEP tests in Ontario would be between $1.29 million (Year 1) and $2.22 million (Year 5) compared to the current scenario of publicly funded GEP tests through the out-of-country program.Gene expression profiling tests are valued by patients and physicians for the additional information they provide for treatment decision-making. Patients are satisfied with what they learn from GEP tests and feel GEP tests can help reduce decisional uncertainty and anxiety.

Conclusions: Gene expression profiling tests can likely prognosticate the risk of distant recurrence and some tests may also predict chemotherapy benefit. In people with breast cancer that is ER+, LN-, and human epidermal growth factor receptor 2 (HER2)-negative, GEP tests are likely cost-effective compared with no testing. The GEP tests are also likely cost-effective in LN+ and premenopausal people. Compared with funding GEP tests through the out-of-country program, publicly funding GEP tests in Ontario would cost an additional $1 million to $2 million annually, assuming a higher uptake of tests. GEP tests are valued by both patients and physicians for chemotherapy treatment decision-making.

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Economic evaluation of the 70-gene prognosis-signature (MammaPrint®) in hormone receptor-positive, lymph node-negative, human epidermal growth factor receptor type 2-negative early stage breast cancer in Japan.
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Br J Cancer, 2016 Mar 10; 114(7). PMID: 26954715    Free PMC article.
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Psychooncology, 2010 Mar 05; 20(1). PMID: 20200857
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Ann Oncol, 2013 Jan 23; 24(3). PMID: 23337633    Free PMC article.
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Springerplus, 2015 Dec 23; 4. PMID: 26693110    Free PMC article.
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Eur J Cancer, 2016 Aug 22; 66. PMID: 27544930
A prospective clinical utility and pharmacoeconomic study of the impact of the 21-gene Recurrence Score® assay in oestrogen receptor positive node negative breast cancer.
J A Davidson, I Cromwell, +15 authors, S K Chia.
Eur J Cancer, 2013 Apr 25; 49(11). PMID: 23611660
Retention and use of breast cancer recurrence risk information from genomic tests: the role of health literacy.
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Cancer Epidemiol Biomarkers Prev, 2007 Feb 03; 16(2). PMID: 17267389
Examination of Health System Resources and Costs Associated With Transitioning Cancer Survivors to Primary Care: A Propensity-Score-Matched Cohort Study.
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BMC Cancer, 2017 Apr 15; 17(1). PMID: 28407750    Free PMC article.
21-Gene Recurrence Score and Locoregional Recurrence in Node-Positive/ER-Positive Breast Cancer Treated With Chemo-Endocrine Therapy.
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Understanding how breast cancer patients use risk information from genomic tests.
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J Clin Oncol, 2013 Jul 03; 31(22). PMID: 23816962
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M C Chang, L H Souter, +6 authors, Molecular Oncology Advisory Committee.
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Value Health, 2013 Mar 30; 16(2). PMID: 23538175
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Association between genomic recurrence risk and well-being among breast cancer patients.
Valesca P Retèl, Catharina G M Groothuis-Oudshoorn, +3 authors, Wim H van Harten.
BMC Cancer, 2013 Jun 20; 13. PMID: 23777535    Free PMC article.
A decision impact, decision conflict and economic assessment of routine Oncotype DX testing of 146 women with node-negative or pNImi, ER-positive breast cancer in the U.K.
S Holt, G Bertelli, +12 authors, C J Phillips.
Br J Cancer, 2013 May 23; 108(11). PMID: 23695023    Free PMC article.
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Reducing chemotherapy use in clinically high-risk, genomically low-risk pN0 and pN1 early breast cancer patients: five-year data from the prospective, randomised phase 3 West German Study Group (WSG) PlanB trial.
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Cancer, 2018 Nov 06; 125(2). PMID: 30387876    Free PMC article.
Results of PONDx, a prospective multicenter study of the Oncotype DX® breast cancer assay: Real-life utilization and decision impact in French clinical practice.
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GENE EXPRESSION PROFILING AND EXPANDED IMMUNOHISTOCHEMISTRY TESTS TO GUIDE SELECTION OF CHEMOTHERAPY REGIMENS IN BREAST CANCER MANAGEMENT: A SYSTEMATIC REVIEW.
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Practical Consequences Resulting from the Analysis of a 21-Multigene Array in the Interdisciplinary Conference of a Breast Cancer Center.
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Optimized outcome prediction in breast cancer by combining the 70-gene signature with clinical risk prediction algorithms.
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Breast Cancer Res Treat, 2014 Apr 25; 145(3). PMID: 24760482    Free PMC article.
Prospective Clinical Utility Study of the Use of the 21-Gene Assay in Adjuvant Clinical Decision Making in Women With Estrogen Receptor-Positive Early Invasive Breast Cancer: Results From the SWITCH Study.
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Impact of a 21-gene RT-PCR assay on treatment decisions in early-stage breast cancer: an economic analysis based on prognostic and predictive validation studies.
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Use of Biomarkers to Guide Decisions on Adjuvant Systemic Therapy for Women With Early-Stage Invasive Breast Cancer: American Society of Clinical Oncology Clinical Practice Guideline Focused Update.
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Breast, 2017 Nov 13; 37. PMID: 29128582
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A pilot study to identify areas for further improvements in patient and public involvement in health technology assessments for medicines.
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Economic analysis of gene expression profile data to guide adjuvant treatment in women with early-stage breast cancer.
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Public Health Genomics, 2013 Apr 11; 16(3). PMID: 23571814
Economic impact of 21-gene recurrence score testing on early-stage breast cancer in Ireland.
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Breast Cancer Res Treat, 2015 Sep 14; 153(3). PMID: 26364296
Impact of Oncotype DX breast Recurrence Score testing on adjuvant chemotherapy use in early breast cancer: Real world experience in Greater Manchester, UK.
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Eur J Surg Oncol, 2017 Jan 24; 43(5). PMID: 28111076
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The PAM50 risk-of-recurrence score predicts risk for late distant recurrence after endocrine therapy in postmenopausal women with endocrine-responsive early breast cancer.
Martin Filipits, Torsten O Nielsen, +22 authors, Austrian Breast and Colorectal Cancer Study Group.
Clin Cancer Res, 2014 Feb 13; 20(5). PMID: 24520097
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Bull Cancer, 2012 Oct 09; 99(10). PMID: 23041366
A gene-expression signature as a predictor of survival in breast cancer.
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N Engl J Med, 2002 Dec 20; 347(25). PMID: 12490681
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Breast cancer survival by molecular subtype: a population-based analysis of cancer registry data.
Saber Fallahpour, Tanya Navaneelan, Prithwish De, Alessia Borgo.
CMAJ Open, 2017 Sep 28; 5(3). PMID: 28951445    Free PMC article.
Prospective study of the impact of the Prosigna assay on adjuvant clinical decision-making in unselected patients with estrogen receptor positive, human epidermal growth factor receptor negative, node negative early-stage breast cancer.
Miguel Martín, Milagros González-Rivera, +22 authors, Aleix Prat.
Curr Med Res Opin, 2015 Apr 09; 31(6). PMID: 25851308
Impact of Oncotype DX Recurrence Score on Treatment Decisions: Results of a Prospective Multicenter Study in Turkey.
Vahit Ozmen, Ajlan Atasoy, +7 authors, Pinar Saip.
Cureus, 2016 Apr 16; 8(3). PMID: 27081583    Free PMC article.
The Impact of the Oncotype DX Breast Cancer Assay on Treatment Decisions for Women With Estrogen Receptor-Positive, Node-Negative Breast Carcinoma in Hong Kong.
Roland C Y Leung, Thomas C C Yau, +12 authors, Polly S Y Cheung.
Clin Breast Cancer, 2016 Apr 24; 16(5). PMID: 27105769
Cost-effectiveness of a 21-gene recurrence score assay versus Canadian clinical practice in women with early-stage estrogen- or progesterone-receptor-positive, axillary lymph-node negative breast cancer.
Malek B Hannouf, Bin Xie, Muriel Brackstone, Gregory S Zaric.
BMC Cancer, 2012 Oct 04; 12. PMID: 23031196    Free PMC article.
Prognostic and predictive value of the 21-gene recurrence score assay in postmenopausal women with node-positive, oestrogen-receptor-positive breast cancer on chemotherapy: a retrospective analysis of a randomised trial.
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Women's experiences with genomic testing for breast cancer recurrence risk.
Janice P Tzeng, Deborah Mayer, +5 authors, Noel T Brewer.
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Probabilistic cost-utility analysis and expected value of perfect information for the Oncotype multigenic test: a discrete event simulation model.
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Prospective Evaluation of the 21-Gene Recurrence Score Assay for Breast Cancer Decision-Making in Ontario.
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Highly Cited.
Clinical outcomes in ER+ HER2 -node-positive breast cancer patients who were treated according to the Recurrence Score results: evidence from a large prospectively designed registry.
Salomon M Stemmer, Mariana Steiner, +13 authors, Noa Ben-Baruch.
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Cost-effectiveness analysis of multigene expression profiling assays to guide adjuvant therapy decisions in women with invasive early-stage breast cancer.
Malek B Hannouf, Gregory S Zaric, +5 authors, Muriel Brackstone.
Pharmacogenomics J, 2019 May 28; 20(1). PMID: 31130722
Prospective multicenter study of the impact of the 21-gene recurrence score assay on medical oncologist and patient adjuvant breast cancer treatment selection.
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Economic implications of 21-gene breast cancer risk assay from the perspective of an Israeli-managed health-care organization.
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Value Health, 2010 Apr 24; 13(4). PMID: 20412544
Factors affecting the adoption and use of gene expression profiling by oncologists in clinical practice.
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Public and patient involvement at the UK National Institute for Health and Clinical Excellence.
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Constructive Technology Assessment (CTA) as a tool in coverage with evidence development: the case of the 70-gene prognosis signature for breast cancer diagnostics.
Valesca P Retèl, Jolien M Bueno-de-Mesquita, +9 authors, Wim H van Harten.
Int J Technol Assess Health Care, 2009 Jan 08; 25(1). PMID: 19126254
The genomic expression test EndoPredict is a prognostic tool for identifying risk of local recurrence in postmenopausal endocrine receptor-positive, her2neu-negative breast cancer patients randomised within the prospective ABCSG 8 trial.
F Fitzal, M Filipits, +9 authors, M Gnant.
Br J Cancer, 2015 Apr 14; 112(8). PMID: 25867274    Free PMC article.
Economic analysis of targeting chemotherapy using a 21-gene RT-PCR assay in lymph-node-negative, estrogen-receptor-positive, early-stage breast cancer.
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Am J Manag Care, 2005 May 19; 11(5). PMID: 15898220
The Impact of EndoPredict Clinical Score on Chemotherapy Recommendations in Women with Invasive ER+/HER2- Breast Cancer Stratified as Having Moderate or Poor Prognosis by Nottingham Prognostic Index.
Kinan Mokbel, Umar Wazir, +2 authors, Kefah Mokbel.
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Cost-utility of the 21-gene recurrence score assay in node-negative and node-positive breast cancer.
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Gene Expression Profiling in Breast Cancer and Its Effect on Therapy Selection in Early-Stage Breast Cancer.
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PAM50 Risk of Recurrence Score Predicts 10-Year Distant Recurrence in a Comprehensive Danish Cohort of Postmenopausal Women Allocated to 5 Years of Endocrine Therapy for Hormone Receptor-Positive Early Breast Cancer.
Anne-Vibeke Lænkholm, Maj-Britt Jensen, +12 authors, Bent Ejlertsen.
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Am J Manag Care, 2017 Dec 21; 23(12). PMID: 29261249
Breast cancer-specific survival in patients with lymph node-positive hormone receptor-positive invasive breast cancer and Oncotype DX Recurrence Score results in the SEER database.
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Highly Cited. Systematic Review.
Comparison of EndoPredict and EPclin With Oncotype DX Recurrence Score for Prediction of Risk of Distant Recurrence After Endocrine Therapy.
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Enhancing decision-making about adjuvant chemotherapy in early breast cancer following EndoPredict testing.
Lesley Fallowfield, Lucy Matthews, +2 authors, David Bloomfield.
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Susanna M Wallerstedt, Astrid Nilsson Ek, +3 authors, Barbro Linderholm.
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Systematic Review.
A Systematic Review of the Value Assessment Frameworks Used within Health Technology Assessment of Omics Technologies and Their Actual Adoption from HTA Agencies.
Ilda Hoxhaj, Laurenz Govaerts, +4 authors, Stefania Boccia.
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Systematic Review.
Recognition of Immune Microenvironment Landscape and Immune-Related Prognostic Genes in Breast Cancer.
Huiling Wang, Shuo You, Meng Fang, Qian Fang.
Biomed Res Int, 2020 Dec 05; 2020. PMID: 33274208    Free PMC article.
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Review.