A new 21-Gene Expression Assay Recurrence Score in Estrogen Receptor-Positive and Lymph Node-Negative Early-Stage Breast Cancer Patients

Abstract

Abstract This aimed to validate 21 Oncotype DX gene in a retrospective trial involving women with hormone receptor-positive, human epidermal growth factor receptor type 2 (HER2)–negative, axillary node-negative breast cancer with tumors measuring 1.1 to 5.0 cm in their largest dimension. The ROC curve for each gene, showed the sensitivity of BAG1 and KI67 ranged between 96.08 and 99.46 percent. Survivin and BAG1 had gene specificities ranging from 95.6–100%. The detection threshold ranged from 26.64 to 31.12 copies for MYBL2 and BAC1, respectively; while ranged from 24.25 to 33.83 copies for RPLP0 and ERBB2, respectively. This retrospective research of uniformly treated patients with hormone–receptor–positive, HER2-negative, and axillary node–negative breast cancer demonstrates the clinical validity of the 21-gene assay.