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


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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Springerplus, 2015 Dec 23; 4. PMID: 26693110    Free PMC article.
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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.
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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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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.
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Breast Cancer Res Treat, 2015 Sep 14; 153(3). PMID: 26364296
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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.
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Bull Cancer, 2012 Oct 09; 99(10). PMID: 23041366
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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.
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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.
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BMC Cancer, 2012 Oct 04; 12. PMID: 23031196    Free PMC article.
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Highly Cited. Systematic Review.
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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.
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Systematic Review.
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Ifat Klein, Leonid Kalichman, Noy Chen, Sergio Susmallian.
Sci Rep, 2021 May 19; 11(1). PMID: 34002007    Free PMC article.
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The Signal Transducer IL6ST (gp130) as a Predictive and Prognostic Biomarker in Breast Cancer.
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