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Review
. 2022 Jul 20;29(7):5139-5149.
doi: 10.3390/curroncol29070407.

Clinical Utility of Genomic Assay in Node-Positive Early-Stage Breast Cancer

Mehrnoosh Pauls  1 , Stephen Chia  1
Affiliations
Review

Clinical Utility of Genomic Assay in Node-Positive Early-Stage Breast Cancer

Mehrnoosh Pauls et al. Curr Oncol. .

Abstract

Breast cancer (BC) is the most common malignancy among women in Canada. Adjuvant treatment in early BC can reduce the risk of BC recurrence. Historically, the decision for adjuvant chemotherapy for early BC was made only based on clinical and tumour characteristics. In recent years, there has been an effort toward developing genomic assays as a predictive and prognostic tool to improve precision in estimating disease recurrence, sensitivity to systemic treatment and ultimately with clinical utility for guidance regarding adjuvant systemic treatment(s). There are various commercial genomic tests available for early-stage ER+/HER-2 negative BC. This paper will review the Oncotype DX 21-gene Recurrence Score (RS), MammaPrint, EndoPredict, Prosigna®, and Breast Cancer Index (BCI) genomic assays. We will also focus on these genomic assays' clinical application and utility in node-positive early-stage BC based on the most recent evidence and guidance recommendations.

Keywords: Breast Cancer Index (BCI); EndoPredict; MammaPrint; Oncotype DX 21-gene Recurrence Score (RS); Prosigna®.

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Conflict of interest statement

Dr. Pauls receives a consulting honoraria and sponsorship from Ipsen, Novartis and Pfizer. All outside of the submitted work. Dr Chia reports honoraria from Novartis, Hoffmann LaRoche, Pfizer, Eli Lilly, Merck, AstraZeneca, Exact Sciences and Gilead.

Figures

Figure 1
Figure 1
Algorithm on usage of biomarkers to guide decisions on adjuvant treatment among patients with node-positive early-stage ER+/HER2– BC as per ASCO updated guidelines 2022. Reprinted with permission from ASCO guidelines. Copyright year 2022, copyright owner’s Wolters Kluwer Health, INC [8].
See this image and copyright information in PMC

References

    1. Markopoulos C., van de Velde C., Zarca D., Ozmen V., Masetti R. Clinical evidence supporting genomic tests in early breast cancer: Do all genomic tests provide the same information? Eur. J. Surg. Oncol. (EJSO) 2017;43:909–920. doi: 10.1016/j.ejso.2016.08.012. - DOI - PubMed
    1. Varga Z., Sinn P., Seidman A.D. Summary of head-to-head comparisons of patient risk classifications by the 21-gene Recurrence Score® (RS) assay and other genomic assays for early breast cancer. Int. J. Cancer. 2019;145:882–893. doi: 10.1002/ijc.32139. - DOI - PubMed
    1. Paik S., Kim C., Baehner F.L., Park T., Wickerham D.L., Wolmark N. A Multigene Assay to Predict Recurrence of Tamoxifen-Treated, Node-Negative Breast Cancer. N. Engl. J. Med. 2004;351:2817–2826. doi: 10.1056/NEJMoa041588. - DOI - PubMed
    1. Sparano J.A., Gray R.J., Makower D.F., Pritchard K.I., Albain K.S., Hayes D.F., Geyer C.E., Jr., Dees E.C., Goetz M.P., Olson J.A., et al. Adjuvant Chemotherapy Guided by a 21-Gene Expression Assay in Breast Cancer. N. Engl. J. Med. 2018;379:111–121. doi: 10.1056/NEJMoa1804710. - DOI - PMC - PubMed
    1. Albain K.S., E Barlow W., Shak S., Hortobagyi G.N., Livingston R.B., Yeh I.-T., Ravdin P., Bugarini R., Baehner F.L., E Davidson N., et al. 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. Lancet Oncol. 2010;11:55–65. doi: 10.1016/S1470-2045(09)70314-6. - DOI - PMC - PubMed