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

H. A. Azim; S. Michiels; F. Zagouri; S. Delaloge; M. Filipits; M. Namer; P. Neven; W. F. Symmans; A. Thompson; F. Andre; S. Loi; C. Swanton

doi:10.1093/annonc/mds645

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

H. A. Azim, S. Michiels, F. Zagouri, S. Delaloge, M. Filipits, M. Namer, P. Neven, W. F. Symmans, A. Thompson, F. Andre, S. Loi, C. Swanton

Research output: Contribution to journal › Article › peer-review

106 Citations (Scopus)

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 (TM), MammaPrint (R), 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 (TM) and MammaPrint (R) 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 (ii) the creation of registries for patients who are subjected to genomic testing in the daily practice.

Original language	English
Pages (from-to)	647-654
Number of pages	8
Journal	Annals of Oncology
Volume	24
Issue number	3
DOIs	https://doi.org/10.1093/annonc/mds645
Publication status	Published - Mar 2013

Keywords

RISK
METASTATIC COLORECTAL-CANCER
VALIDATION
ASSAY
GRADE
PREDICTOR
SUBTYPES
prediction
prognosis
GENE-EXPRESSION SIGNATURE
ADJUVANT
breast cancer
genomic signatures
RECURRENCE SCORE

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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

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 (TM), MammaPrint (R), 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 (TM) and MammaPrint (R) 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 (ii) the creation of registries for patients who are subjected to genomic testing in the daily practice.",

keywords = "RISK, METASTATIC COLORECTAL-CANCER, VALIDATION, ASSAY, GRADE, PREDICTOR, SUBTYPES, prediction, prognosis, GENE-EXPRESSION SIGNATURE, ADJUVANT, breast cancer, genomic signatures, RECURRENCE SCORE",

author = "Azim, {H. A.} and S. Michiels and F. Zagouri and S. Delaloge and M. Filipits and M. Namer and P. Neven and Symmans, {W. F.} and A. Thompson and F. Andre and S. Loi and C. Swanton",

year = "2013",

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doi = "10.1093/annonc/mds645",

language = "English",

volume = "24",

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T1 - Utility of prognostic genomic tests in breast cancer practice

T2 - The IMPAKT 2012 Working Group Consensus Statement

AU - Azim, H. A.

AU - Michiels, S.

AU - Zagouri, F.

AU - Delaloge, S.

AU - Filipits, M.

AU - Namer, M.

AU - Neven, P.

AU - Symmans, W. F.

AU - Thompson, A.

AU - Andre, F.

AU - Loi, S.

AU - Swanton, C.

PY - 2013/3

Y1 - 2013/3

N2 - 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 (TM), MammaPrint (R), 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 (TM) and MammaPrint (R) 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 (ii) the creation of registries for patients who are subjected to genomic testing in the daily practice.

AB - 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 (TM), MammaPrint (R), 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 (TM) and MammaPrint (R) 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 (ii) the creation of registries for patients who are subjected to genomic testing in the daily practice.

KW - RISK

KW - METASTATIC COLORECTAL-CANCER

KW - VALIDATION

KW - ASSAY

KW - GRADE

KW - PREDICTOR

KW - SUBTYPES

KW - prediction

KW - prognosis

KW - GENE-EXPRESSION SIGNATURE

KW - ADJUVANT

KW - breast cancer

KW - genomic signatures

KW - RECURRENCE SCORE

U2 - 10.1093/annonc/mds645

DO - 10.1093/annonc/mds645

M3 - Article

SN - 0923-7534

VL - 24

SP - 647

EP - 654

JO - Annals of Oncology

JF - Annals of Oncology

IS - 3

ER -

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

Abstract

Keywords

UN SDGs

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