RECOMMENDATIONS In addition to estrogen and progesterone receptors and human epidermal growth factor receptor 2 , the panel found sufficient evidence of clinical utility for the biomarker assays Oncotype DX , EndoPredict , PAM50 , Breast Cancer Index , and urokinase plasminogen activator and plasminogen activator inhibitor type 1 in specific subgroups of breast cancer .
No biomarker except for estrogen receptor , progesterone receptor , and human epidermal growth factor receptor 2 was found to guide choices of specific treatment regimens .
PURPOSE To provide recommendations on appropriate use of breast tumor biomarker assay results to guide decisions on adjuvant systemic therapy for women with early-stage invasive breast cancer .
Measuring the Performance of Markers for Guiding Treatment Decisions
Treatment selection markers , sometimes called predictive markers , are factors that help clinicians select therapies that maximize good outcomes and minimize adverse outcomes for patients . Existing statistical methods for evaluating a treatment selection marker include assessing its prognostic value , evaluating treatment effects in patients with a restricted range of marker values , and testing for a statistical interaction between marker value and treatment . These methods are inadequate , because they give misleading measures of performance that do not answer key clinical questions about how the marker might help patients choose treatment , how treatment decisions should be made on the basis of a continuous marker measurement , what effect using the marker to select treatment would have on the population , or what proportion of patients would have treatment changes on the basis of marker measurement . Marker-by-treatment predictiveness curves are proposed as a more useful aid to answering these clinical ly relevant questions , because they illustrate treatment effects as a function of marker value , outcomes when using or not using the marker to select treatment , and the proportion of patients for whom treatment recommendations change after marker measurement . R and omized therapeutic clinical trials , in which entry criteria and treatment regimens are not restricted by the marker , are also proposed as the basis for constructing the curves and evaluating and comparing markers
RECOMMENDATIONS In addition to estrogen and progesterone receptors and human epidermal growth factor receptor 2 , the panel found sufficient evidence of clinical utility for the biomarker assays Oncotype DX , EndoPredict , PAM50 , Breast Cancer Index , and urokinase plasminogen activator and plasminogen activator inhibitor type 1 in specific subgroups of breast cancer .
No biomarker except for estrogen receptor , progesterone receptor , and human epidermal growth factor receptor 2 was found to guide choices of specific treatment regimens .
PURPOSE To provide recommendations on appropriate use of breast tumor biomarker assay results to guide decisions on adjuvant systemic therapy for women with early-stage invasive breast cancer .