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

HA Azim Jr, S Michiels, F Zagouri, S Delaloge… - Annals of oncology, 2013 - Elsevier
HA Azim Jr, S Michiels, F Zagouri, S Delaloge, M Filipits, M Namer, P Neven, WF Symmans
Annals of oncology, 2013Elsevier
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 …
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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