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 .
A New Molecular Predictor of Distant Recurrence in ER-Positive, HER2-Negative Breast Cancer Adds Independent Information to Conventional Clinical Risk Factors
Purpose : According to current guidelines , molecular tests predicting the outcome of breast cancer patients can be used to assist in making treatment decisions after consideration of conventional markers . We developed and vali date d a gene expression signature predicting the likelihood of distant recurrence in patients with estrogen receptor (ER)–positive , HER2-negative breast cancer treated with adjuvant endocrine therapy .  Experimental Design : RNA levels assessed by quantitative reverse transcriptase PCR in formalin-fixed , paraffin-embedded tumor tissue were used to calculate a risk score ( Endopredict , EP ) consisting of eight cancer-related and three reference genes . EP was combined with nodal status and tumor size into a comprehensive risk score , EPclin . Both prespecified risk scores including cutoff values to determine a risk group for each patient ( low and high ) were vali date d independently in patients from two large r and omized phase III trials [ Austrian Breast and Colorectal Cancer Study Group (ABCSG)-6 : n = 378 , ABCSG-8 : n = 1,324 ] . Results : In both validation cohorts , continuous EP was an independent predictor of distant recurrence in multivariate analysis ( ABCSG-6 : P = 0.010 , ABCSG-8 : P < 0.001 ) . Combining Adjuvant!Online , quantitative ER , Ki67 , and treatment with EP yielded a prognostic power significantly superior to the clinicopathologic factors alone [ c-indices : 0.764 vs. 0.750 , P = 0.024 ( ABCSG-6 ) and 0.726 vs. 0.701 , P = 0.003 ( ABCSG-8 ) ] . EPclin had c-indices of 0.788 and 0.732 and result ed in 10-year distant recurrence rates of 4 % and 4 % in EPclin low-risk and 28 % and 22 % in EPclin high-risk patients in ABCSG-6 ( P < 0.001 ) and ABCSG-8 ( P < 0.001 ) , respectively . Conclusions : The multigene EP risk score provided additional prognostic information to the risk of distant recurrence of breast cancer patients , independent from clinicopathologic parameters . The EPclin score outperformed all conventional clinicopathologic risk factors . Clin Cancer Res ; 17(18 ) ; 6012–20 . © 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 .