title: Clinical utility of gene-expression profiling in women with early breast cancer: an overview of systematic reviews.
abstract: OBJECTIVE
  This overview systematically evaluates the clinical utility of using Oncotype DX and MammaPrint gene-expression profiling tests to direct treatment decisions in women with breast cancer. The findings are intended to inform an updated recommendation from the Evaluation of Genomic Applications in Practice and Prevention Working Group.
  
  
  METHODS
  Evidence reported in systematic reviews evaluating the clinical utility of Oncotype DX and MammaPrint, as well as the ability to predict treatment outcomes, change in treatment decisions, and cost-effectiveness, was qualitatively synthesized.
  
  
  RESULTS
  Five systematic reviews found no direct evidence of clinical utility for either test. Indirect evidence showed Oncotype DX was able to predict treatment effects of adjuvant chemotherapy, whereas no evidence of predictive value was found for MammaPrint. Both tests influenced a change in treatment recommendations in 21 to 74% of participants. The cost-effectiveness of Oncotype DX varied with the alternative compared. For MammaPrint, lack of evidence of the predictive value led to uncertainty in the cost-effectiveness.
  
  
  CONCLUSIONS
  No studies were identified that provided direct evidence that using gene-expression profiling tests to direct treatment decisions improved outcomes in women with breast cancer. Three ongoing studies may provide direct evidence for determining the clinical utility of gene-expression profiling testing.
authors.affiliation: 1] McKing Consulting Corporation, Atlanta, Georgia, USA [2] Office of Public Health Genomics, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.
authors.forename: Michael
authors.initials: M
authors.lastname: Marrone
authors.affiliation: 1] McKing Consulting Corporation, Atlanta, Georgia, USA [2] Office of Public Health Genomics, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.
authors.forename: Alison
authors.identifier: 0000000237242711
authors.initials: A
authors.lastname: Stewart
authors.affiliation: Office of Public Health Genomics, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.
authors.forename: W David
authors.initials: WD
authors.lastname: Dotson
mesh_terms: D001943:Breast Neoplasms / Q000175:diagnosis / Q000235:genetics* / Q000628:therapy; D003362:Cost-Benefit Analysis; D005260:Female; D020869:Gene Expression Profiling / Q000191:economics / Q000379:methods*; D006801:Humans; D011237:Predictive Value of Tests; D059467:Transcriptome; D016896:Treatment Outcome