Recommendations from the EGAPP Working Group: Can tumor gene expression profiling improve outcomes in patients with breast cancer?

Alfred O. Berg, Katrina Armstrong, Jeffrey Botkin, Ned Calonge, James Haddow, Maxine Hayes, Celia Kaye, Kathryn A. Phillips, Margaret Piper, Carolyn (Sue) Richards, Joan A. Scott, Ora L. Strickland, Steven Teutsch

Research output: Contribution to journalArticle

119 Citations (Scopus)

Abstract

Summary of Recommendations: The EGAPP Working Group (EWG) found insufficient evidence to make a recommendation for or against the use of tumor gene expression profiles to improve outcomes in defined populations of women with breast cancer. For one test, the EWG found preliminary evidence of potential benefit of testing results to some women who face decisions about treatment options (reduced adverse events due to low risk women avoiding chemotherapy), but could not rule out the potential for harm for others (breast cancer recurrence that might have been prevented). The evidence is insufficient to assess the balance of benefits and harms of the proposed uses of the tests. The EWG encourages further development and evaluation of these technologies. Rationale: The measurement of gene expression in breast tumor tissue is proposed as a way to estimate the risk of distant disease recurrence in order to provide additional information beyond current clinicopathological risk stratification and to influence decisions about treatment in order to improve health outcomes. Based on their review of the EGAPP-commissioned evidence report, Impact of Gene Expression Profiling Tests on Breast Cancer Outcomes 1 and other data summaries, the EWG found no direct evidence linking tumor gene expression profiling of women with breast cancer to improved outcomes, and inadequate evidence to construct an evidence chain. However, further evaluation on the clinical utility of some tests and management algorithms, including well-designed randomized controlled trials, is warranted. Analytic Validity: Some data on technical performance of assays were identified for Mam-maPrint and Oncotype DX, though estimates of analytic sensitivity and specificity could not be made. Published performance data on the laboratory developed Quest H:I Test were limited. Overall, the EWG found the evidence to be inadequate. Clinical Validity: The EWG found adequate evidence regarding the association of the Oncotype DX Recurrence Score with disease recurrence and adequate evidence for response to chemotherapy. The EWG found adequate evidence to characterize the association of MammaPrint with future metastases, but inadequate evidence to assess the added value to standard risk stratification, and could not determine the population to which the test would best apply. The evidence was inadequate to characterize the clinical validity of the Quest H:I Test. Clinical Utility: The EWG found no evidence regarding the clinical utility of the MammaPrint and Quest H:I Ratio tests, and inadequate evidence regarding Oncotype DX. These technologies have potential for both benefit and harm. Contextual Issues: The EWG reviewed economic studies that used modeling to predict potential effects of using gene profiling, and judged the evidence inadequate.

Original languageEnglish (US)
Pages (from-to)66-73
Number of pages8
JournalGenetics in Medicine
Volume11
Issue number1
DOIs
StatePublished - Jan 2009

Fingerprint

Gene Expression Profiling
Breast Neoplasms
Recurrence
Neoplasms
Technology
Drug Therapy
Transcriptome
Population
Randomized Controlled Trials
Economics
Neoplasm Metastasis
Gene Expression
Sensitivity and Specificity
Health
Therapeutics
Genes

Keywords

  • Breast cancer
  • Recurrence
  • Tumor gene expression

ASJC Scopus subject areas

  • Genetics(clinical)

Cite this

Recommendations from the EGAPP Working Group : Can tumor gene expression profiling improve outcomes in patients with breast cancer? / Berg, Alfred O.; Armstrong, Katrina; Botkin, Jeffrey; Calonge, Ned; Haddow, James; Hayes, Maxine; Kaye, Celia; Phillips, Kathryn A.; Piper, Margaret; Richards, Carolyn (Sue); Scott, Joan A.; Strickland, Ora L.; Teutsch, Steven.

In: Genetics in Medicine, Vol. 11, No. 1, 01.2009, p. 66-73.

Research output: Contribution to journalArticle

Berg, AO, Armstrong, K, Botkin, J, Calonge, N, Haddow, J, Hayes, M, Kaye, C, Phillips, KA, Piper, M, Richards, CS, Scott, JA, Strickland, OL & Teutsch, S 2009, 'Recommendations from the EGAPP Working Group: Can tumor gene expression profiling improve outcomes in patients with breast cancer?', Genetics in Medicine, vol. 11, no. 1, pp. 66-73. https://doi.org/10.1097/GIM.0b013e3181928f56
Berg, Alfred O. ; Armstrong, Katrina ; Botkin, Jeffrey ; Calonge, Ned ; Haddow, James ; Hayes, Maxine ; Kaye, Celia ; Phillips, Kathryn A. ; Piper, Margaret ; Richards, Carolyn (Sue) ; Scott, Joan A. ; Strickland, Ora L. ; Teutsch, Steven. / Recommendations from the EGAPP Working Group : Can tumor gene expression profiling improve outcomes in patients with breast cancer?. In: Genetics in Medicine. 2009 ; Vol. 11, No. 1. pp. 66-73.
@article{d2d4c74a55554cb9835124bf3cd8290d,
title = "Recommendations from the EGAPP Working Group: Can tumor gene expression profiling improve outcomes in patients with breast cancer?",
abstract = "Summary of Recommendations: The EGAPP Working Group (EWG) found insufficient evidence to make a recommendation for or against the use of tumor gene expression profiles to improve outcomes in defined populations of women with breast cancer. For one test, the EWG found preliminary evidence of potential benefit of testing results to some women who face decisions about treatment options (reduced adverse events due to low risk women avoiding chemotherapy), but could not rule out the potential for harm for others (breast cancer recurrence that might have been prevented). The evidence is insufficient to assess the balance of benefits and harms of the proposed uses of the tests. The EWG encourages further development and evaluation of these technologies. Rationale: The measurement of gene expression in breast tumor tissue is proposed as a way to estimate the risk of distant disease recurrence in order to provide additional information beyond current clinicopathological risk stratification and to influence decisions about treatment in order to improve health outcomes. Based on their review of the EGAPP-commissioned evidence report, Impact of Gene Expression Profiling Tests on Breast Cancer Outcomes 1 and other data summaries, the EWG found no direct evidence linking tumor gene expression profiling of women with breast cancer to improved outcomes, and inadequate evidence to construct an evidence chain. However, further evaluation on the clinical utility of some tests and management algorithms, including well-designed randomized controlled trials, is warranted. Analytic Validity: Some data on technical performance of assays were identified for Mam-maPrint and Oncotype DX, though estimates of analytic sensitivity and specificity could not be made. Published performance data on the laboratory developed Quest H:I Test were limited. Overall, the EWG found the evidence to be inadequate. Clinical Validity: The EWG found adequate evidence regarding the association of the Oncotype DX Recurrence Score with disease recurrence and adequate evidence for response to chemotherapy. The EWG found adequate evidence to characterize the association of MammaPrint with future metastases, but inadequate evidence to assess the added value to standard risk stratification, and could not determine the population to which the test would best apply. The evidence was inadequate to characterize the clinical validity of the Quest H:I Test. Clinical Utility: The EWG found no evidence regarding the clinical utility of the MammaPrint and Quest H:I Ratio tests, and inadequate evidence regarding Oncotype DX. These technologies have potential for both benefit and harm. Contextual Issues: The EWG reviewed economic studies that used modeling to predict potential effects of using gene profiling, and judged the evidence inadequate.",
keywords = "Breast cancer, Recurrence, Tumor gene expression",
author = "Berg, {Alfred O.} and Katrina Armstrong and Jeffrey Botkin and Ned Calonge and James Haddow and Maxine Hayes and Celia Kaye and Phillips, {Kathryn A.} and Margaret Piper and Richards, {Carolyn (Sue)} and Scott, {Joan A.} and Strickland, {Ora L.} and Steven Teutsch",
year = "2009",
month = "1",
doi = "10.1097/GIM.0b013e3181928f56",
language = "English (US)",
volume = "11",
pages = "66--73",
journal = "Genetics in Medicine",
issn = "1098-3600",
publisher = "Lippincott Williams and Wilkins",
number = "1",

}

TY - JOUR

T1 - Recommendations from the EGAPP Working Group

T2 - Can tumor gene expression profiling improve outcomes in patients with breast cancer?

AU - Berg, Alfred O.

AU - Armstrong, Katrina

AU - Botkin, Jeffrey

AU - Calonge, Ned

AU - Haddow, James

AU - Hayes, Maxine

AU - Kaye, Celia

AU - Phillips, Kathryn A.

AU - Piper, Margaret

AU - Richards, Carolyn (Sue)

AU - Scott, Joan A.

AU - Strickland, Ora L.

AU - Teutsch, Steven

PY - 2009/1

Y1 - 2009/1

N2 - Summary of Recommendations: The EGAPP Working Group (EWG) found insufficient evidence to make a recommendation for or against the use of tumor gene expression profiles to improve outcomes in defined populations of women with breast cancer. For one test, the EWG found preliminary evidence of potential benefit of testing results to some women who face decisions about treatment options (reduced adverse events due to low risk women avoiding chemotherapy), but could not rule out the potential for harm for others (breast cancer recurrence that might have been prevented). The evidence is insufficient to assess the balance of benefits and harms of the proposed uses of the tests. The EWG encourages further development and evaluation of these technologies. Rationale: The measurement of gene expression in breast tumor tissue is proposed as a way to estimate the risk of distant disease recurrence in order to provide additional information beyond current clinicopathological risk stratification and to influence decisions about treatment in order to improve health outcomes. Based on their review of the EGAPP-commissioned evidence report, Impact of Gene Expression Profiling Tests on Breast Cancer Outcomes 1 and other data summaries, the EWG found no direct evidence linking tumor gene expression profiling of women with breast cancer to improved outcomes, and inadequate evidence to construct an evidence chain. However, further evaluation on the clinical utility of some tests and management algorithms, including well-designed randomized controlled trials, is warranted. Analytic Validity: Some data on technical performance of assays were identified for Mam-maPrint and Oncotype DX, though estimates of analytic sensitivity and specificity could not be made. Published performance data on the laboratory developed Quest H:I Test were limited. Overall, the EWG found the evidence to be inadequate. Clinical Validity: The EWG found adequate evidence regarding the association of the Oncotype DX Recurrence Score with disease recurrence and adequate evidence for response to chemotherapy. The EWG found adequate evidence to characterize the association of MammaPrint with future metastases, but inadequate evidence to assess the added value to standard risk stratification, and could not determine the population to which the test would best apply. The evidence was inadequate to characterize the clinical validity of the Quest H:I Test. Clinical Utility: The EWG found no evidence regarding the clinical utility of the MammaPrint and Quest H:I Ratio tests, and inadequate evidence regarding Oncotype DX. These technologies have potential for both benefit and harm. Contextual Issues: The EWG reviewed economic studies that used modeling to predict potential effects of using gene profiling, and judged the evidence inadequate.

AB - Summary of Recommendations: The EGAPP Working Group (EWG) found insufficient evidence to make a recommendation for or against the use of tumor gene expression profiles to improve outcomes in defined populations of women with breast cancer. For one test, the EWG found preliminary evidence of potential benefit of testing results to some women who face decisions about treatment options (reduced adverse events due to low risk women avoiding chemotherapy), but could not rule out the potential for harm for others (breast cancer recurrence that might have been prevented). The evidence is insufficient to assess the balance of benefits and harms of the proposed uses of the tests. The EWG encourages further development and evaluation of these technologies. Rationale: The measurement of gene expression in breast tumor tissue is proposed as a way to estimate the risk of distant disease recurrence in order to provide additional information beyond current clinicopathological risk stratification and to influence decisions about treatment in order to improve health outcomes. Based on their review of the EGAPP-commissioned evidence report, Impact of Gene Expression Profiling Tests on Breast Cancer Outcomes 1 and other data summaries, the EWG found no direct evidence linking tumor gene expression profiling of women with breast cancer to improved outcomes, and inadequate evidence to construct an evidence chain. However, further evaluation on the clinical utility of some tests and management algorithms, including well-designed randomized controlled trials, is warranted. Analytic Validity: Some data on technical performance of assays were identified for Mam-maPrint and Oncotype DX, though estimates of analytic sensitivity and specificity could not be made. Published performance data on the laboratory developed Quest H:I Test were limited. Overall, the EWG found the evidence to be inadequate. Clinical Validity: The EWG found adequate evidence regarding the association of the Oncotype DX Recurrence Score with disease recurrence and adequate evidence for response to chemotherapy. The EWG found adequate evidence to characterize the association of MammaPrint with future metastases, but inadequate evidence to assess the added value to standard risk stratification, and could not determine the population to which the test would best apply. The evidence was inadequate to characterize the clinical validity of the Quest H:I Test. Clinical Utility: The EWG found no evidence regarding the clinical utility of the MammaPrint and Quest H:I Ratio tests, and inadequate evidence regarding Oncotype DX. These technologies have potential for both benefit and harm. Contextual Issues: The EWG reviewed economic studies that used modeling to predict potential effects of using gene profiling, and judged the evidence inadequate.

KW - Breast cancer

KW - Recurrence

KW - Tumor gene expression

UR - http://www.scopus.com/inward/record.url?scp=59849127767&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=59849127767&partnerID=8YFLogxK

U2 - 10.1097/GIM.0b013e3181928f56

DO - 10.1097/GIM.0b013e3181928f56

M3 - Article

C2 - 19125125

AN - SCOPUS:59849127767

VL - 11

SP - 66

EP - 73

JO - Genetics in Medicine

JF - Genetics in Medicine

SN - 1098-3600

IS - 1

ER -