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Breast malignant, males, children

Breast cancer

Prognostic factors - Multigene products

Reviewer: Monika Roychowdhury, M.D. (see Reviewers page)
Revised: 10 November 2012, last major update March 2012
Copyright: (c) 2001-2012, PathologyOutlines.com, Inc.

Multigene prognostic products


● Gene expression profiles are associated with overall survival for several tumor types, including breast (N Engl J Med 2007;356:217)
● Several multigene prognostic products are commercially successful, including oncotype DX™ and MammaPrint® (Oncologist 2008;13:477, Adv Anat Pathol 2009;16:204)
● US Food and Drug Administration has in vitro diagnostic multivariate index assay (IVDMIA) classification for these tests (link)
● For all tests, the relationship of predicted to observed risk in different populations and their incremental contribution over conventional predictors, optimal implementation, and relevance to patients receiving current therapies need further study (Ann Intern Med 2008;148:358, Ann Oncol 2007;18 Suppl 6:vi58, Genet Med 2009;11:66)
● Testing most valuable for ER+ HER2- patients (Breast 2011;20:S87)


● Prognostic test for women under age of 61 years with lymph node-negative breast cancer (ER positive or negative)
● Requires freshly prepared tissue collected in RNA preservative solution
● The assay is comprised of 70 genes focused on proliferation, invasion, metastasis, stromal integrity and angiogenesis


● Uses five immunohistochemical markers (p53, HTF9C, CEACAM5, NDRG1 and SLC7A5) on paraffin fixed tissue to stratify patients on tamoxifen therapy into risk groups to inform treatment decisions
● Increased scores were significantly associated with reduced survival in ER+ positive breast cancer (Breast Cancer Res 2010;12:R47)

Oncotype DX™

● First available in January 2004
● Measures changes in 21 genes on paraffin fixed tissue to predict likelihood of disease recurrence and which patients are most likely to respond to chemotherapy (Breast Cancer Res 2006;8:R25)
● Recurrence score is used for some patients with ER+, node negative breast cancer
● Recurrence score is associated with real world decision changes (Am J Surg 2008;196:527, J Surg Oncol 2009;99:319); use is increasing, reduces adjuvant chemotherapy utilization (Ann Surg Oncol 2011;18:3399)

End of Breast malignant, males, children > Breast cancer > Prognostic factors - Multigene products

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