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 .
Prognostic and predictive value of centrally reviewed Ki-67 labeling index in postmenopausal women with endocrine-responsive breast cancer: results from Breast International Group Trial 1-98 comparing adjuvant tamoxifen with letrozole.
PURPOSE To evaluate the prognostic and predictive value of Ki-67 labeling index ( LI ) in a trial comparing letrozole ( Let ) with tamoxifen ( Tam ) as adjuvant therapy in postmenopausal women with early breast cancer . PATIENTS AND METHODS Breast International Group ( BIG ) trial 1 - 98 r and omly assigned 8,010 patients to four treatment arms comparing Let and Tam with sequences of each agent .  Of 4,922 patients r and omly assigned to receive 5 years of monotherapy with either agent , 2,685 had primary tumor material available for central pathology assessment of Ki-67 LI by immunohistochemistry and had tumors confirmed to express estrogen receptors after central review . The prognostic and predictive value of central ly measured Ki-67 LI on disease-free survival ( DFS ) were assessed among these patients using proportional hazards modeling , with Ki-67 LI values dichotomized at the median value of 11 % . RESULTS Higher values of Ki-67 LI were associated with adverse prognostic factors and with worse DFS ( hazard ratio [ HR ; high : low ] = 1.8 ; 95 % CI , 1.4 to 2.3 ) . The magnitude of the treatment benefit for Let versus Tam was greater among patients with high tumor Ki-67 LI ( HR [ Let : Tam ] = 0.53 ; 95 % CI , 0.39 to 0.72 ) than among patients with low tumor Ki-67 LI ( HR [ Let : Tam ] = 0.81 ; 95 % CI , 0.57 to 1.15 ; interaction P = .09 ) . CONCLUSION Ki-67 LI is confirmed as a prognostic factor in this study . High Ki-67 LI levels may identify a patient group that particularly benefits from initial Let adjuvant therapy
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 .