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. 2013 Mar;24(3):647-54.
doi: 10.1093/annonc/mds645. Epub 2013 Jan 20.

Utility of prognostic genomic tests in breast cancer practice: The IMPAKT 2012 Working Group Consensus Statement

H A Azim Jr  1 , S Michiels, F Zagouri, S Delaloge, M Filipits, M Namer, P Neven, W F Symmans, A Thompson, F André, S Loi, C Swanton
Affiliations

Utility of prognostic genomic tests in breast cancer practice: The IMPAKT 2012 Working Group Consensus Statement

H A Azim Jr et al. Ann Oncol. 2013 Mar.

Abstract

Background: We critically evaluated the available evidence on genomic tests in breast cancer to define their prognostic ability and likelihood to determine treatment benefit.

Design: Independent evaluation of six genomic tests [Oncotype Dx™, MammaPrint(®), Genomic Grade Index, PAM50 (ROR-S), Breast Cancer Index, and EndoPredict] was carried out by a panel of experts in three parameters: analytical validity, clinical validity, and clinical utility based on the principles of the EGAPP criteria. PANEL STATEMENTS: The majority of the working group members found the available evidence on the analytical and clinical validity of Oncotype Dx™ and MammaPrint(®) to be convincing. None of the genomic tests demonstrated robust evidence of clinical utility: it was not clear from the current evidence that modifying treatment decisions based on the results of a given genomic test could result in improving clinical outcome.

Conclusions: The IMPAKT 2012 Working Group proposed the following recommendations: (i) a need to develop models that integrate clinicopathologic factors along with genomic tests; (ii) demonstration of clinical utility should be made in the context of a prospective randomized trial; and (iii) the creation of registries for patients who are subjected to genomic testing in the daily practice.

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References

    1. Perou CM, Sorlie T, Eisen MB, et al. Molecular portraits of human breast tumours. Nature. 2000;406:747–752. - PubMed
    1. Sorlie T, Perou CM, Tibshirani R, et al. Gene expression patterns of breast carcinomas distinguish tumor subclasses with clinical implications. Proc Natl Acad Sci USA. 2001;98:10869–10874. - PMC - PubMed
    1. Sotiriou C, Neo SY, McShane LM, et al. Breast cancer classification and prognosis based on gene expression profiles from a population-based study. Proc Natl Acad Sci USA. 2003;100:10393–10398. - PMC - PubMed
    1. Sotiriou C, Pusztai L. Gene-expression signatures in breast cancer. N Engl J Med. 2009;360:790–800. - PubMed
    1. Henry LR, Stojadinovic A, Swain SM, et al. The influence of a gene expression profile on breast cancer decisions. J Surg Oncol. 2009;99:319–323. - PubMed

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