TY - JOUR
T1 - The value of multigene predictors of clinical outcome in breast cancer
T2 - An analysis of the evidence
AU - Issa, Amalia M.
AU - Chaudhari, Vivek S.
AU - Marchant, Gary
N1 - Funding Information:
This work was supported by grant 5R01HG00614502 from the National Human Genome Research Institute of the NIH. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.
Publisher Copyright:
© 2015 Informa UK, Ltd.
PY - 2015/2/1
Y1 - 2015/2/1
N2 - Objective: Multigene predictors are being used increasingly in early-stage breast cancer patients for prediction and prognosis. However, one consequence of the increased use of multigene predictors, and the heightened efforts toward their incorporation into routine clinical practice, is the potential for future malpractice litigation. It is, therefore, important to ascertain the strength of the evidence for using the different commercially available multigene predictor assays clinically. We evaluated the literature for evidence of clinical validity of four currently available gene signatures and to assess the influence of the 21-gene-expression assay on changes in treatment recommendations. Methods: A systematic search of the peer-reviewed literature from January 2002 to March 2014 for multigene predictor assays was carried out, and a meta-analysis was conducted. Results: The adjusted Cox hazard ratio average for studies that met the eligibility criteria was 3.538 (95% CI: 1.513-8.469). The 21-gene signature showed the highest stability in the estimation of likelihood of distant risk of recurrence. Using the recurrence scores resulted in changes in treatment recommendations in 31.8% of all patients in the studies. Conclusion: This study may provide insight about the use of multigene predictors in clinical practice for prediction and prognosis of breast cancer.
AB - Objective: Multigene predictors are being used increasingly in early-stage breast cancer patients for prediction and prognosis. However, one consequence of the increased use of multigene predictors, and the heightened efforts toward their incorporation into routine clinical practice, is the potential for future malpractice litigation. It is, therefore, important to ascertain the strength of the evidence for using the different commercially available multigene predictor assays clinically. We evaluated the literature for evidence of clinical validity of four currently available gene signatures and to assess the influence of the 21-gene-expression assay on changes in treatment recommendations. Methods: A systematic search of the peer-reviewed literature from January 2002 to March 2014 for multigene predictor assays was carried out, and a meta-analysis was conducted. Results: The adjusted Cox hazard ratio average for studies that met the eligibility criteria was 3.538 (95% CI: 1.513-8.469). The 21-gene signature showed the highest stability in the estimation of likelihood of distant risk of recurrence. Using the recurrence scores resulted in changes in treatment recommendations in 31.8% of all patients in the studies. Conclusion: This study may provide insight about the use of multigene predictors in clinical practice for prediction and prognosis of breast cancer.
KW - Cox hazard ratios
KW - breast cancer
KW - gene-expression profiling
KW - meta-analysis
KW - multigene predictors
KW - recurrence score
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U2 - 10.1586/14737159.2015.983476
DO - 10.1586/14737159.2015.983476
M3 - Review article
C2 - 25479414
AN - SCOPUS:84921326144
SN - 1473-7159
VL - 15
SP - 277
EP - 286
JO - Expert Review of Molecular Diagnostics
JF - Expert Review of Molecular Diagnostics
IS - 2
ER -