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 .
p53 Expression in Node-Positive Breast Cancer Patients: Results from the Cancer and Leukemia Group B 9344 Trial (159905)
Purpose : p53 as a prognostic and predictive factor in early-stage breast cancer has had mixed results . We studied p53 protein expression , by immunohistochemistry , in a r and omized clinical trial of stage II patients treated with adjuvant doxorubicin and cyclophosphamide with or without paclitaxel [ Cancer and Leukemia Group B ( CALGB ) 9344 , INT0148 ] . Patients and Methods : Epithelial p53 expression was evaluated using two immunohistochemical antibodies ( DO7 and 1801 ) in formalin-fixed , paraffin-embedded tissue from patients with node-positive breast cancer who were r and omized to four cycles of cyclophosphamide and one of three doses of doxorubicin  ( 60 , 75 , or 90 mg/m2 ; AC ) and to receive four subsequent cycles of paclitaxel ( T ) or not . Prognostic and predictive value of p53 protein expression was assessed , independent of treatment assignment , for escalating doses of doxorubicin or addition of T with endpoints of relapse-free ( RFS ) and overall survival ( OS ) . Results : Of 3,121 patients , 1,887 patient specimens treated on C9344 were obtained , passed quality control , and evaluated for p53 expression . Expression was 23 % and 27 % for mAbs 1801 and D07 , respectively , with 92 % concordance . In univariate analysis , p53 positivity was associated with worse OS with either antibody , but only p53 staining with monoclonal antibody 1801 had significantly worse RFS . In multivariate analysis , p53 was not predictive of RFS or OS from either doxorubicin dose escalation or addition of paclitaxel regardless of the antibody . Conclusion : Nuclear staining of p53 by immunohistochemistry is associated with worse prognosis in node-positive patients treated with adjuvant doxorubicin-based chemotherapy  but is not a useful predictor of benefit from doxorubicin dose escalation or the addition of paclitaxel . Clin Cancer Res ; 17(15 ) ; 5170–8 . © 2011 AACR
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 .