The OncoMasTR test predicts distant recurrence in estrogen receptor-positive, HER2-negative early-stage breast cancer: A validation study in ABCSG Trial 8.

Abstract

PURPOSE\nTo validate the clinical performance of the OncoMasTR Risk Score in the biomarker cohort of ABCSG Trial 8.\n\n\nEXPERIMENTAL DESIGN\nWe evaluated the OncoMasTR test in 1200 formalin-fixed, paraffin-embedded surgical specimens from postmenopausal women with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative primary breast cancer with 0-3 involved lymph nodes in the prospective, randomized ABCSG Trial 8. Time to distant recurrence (DR) was analyzed by Cox models.\n\n\nRESULTS\nThe OncoMasTR Risk Score categorized 850 of 1087 (78.2%) evaluable patients as low risk . At 10 years, the DR rate for patients in the low-risk group was 5.8% versus 21.1% for patients in the high-risk group (P<0.0001, absolute risk reduction 15.3%). The OncoMasTR Risk Score was highly prognostic for prediction of DR in years 0-10 in all patients (hazard ratio (HR) 1.91, 95% confidence interval (CI) 1.62 to 2.26, P<0.0001; C-index 0.73), in node-negative patients (HR 1.79, 95% CI 1.43 to 2.24, P<0.0001; C-index 0.72), and in patients with 1-3 involved lymph nodes (HR 1.93, 95% CI 1.44 to 2.58, P<0.0001; C-index 0.71). The OncoMasTR Risk Score provided significant additional prognostic information beyond clinical parameters, Ki67, Nottingham Prognostic Index, and Clinical Treatment Score.\n\n\nCONCLUSIONS\nOncoMasTR Risk Score is highly prognostic for DR in postmenopausal women with ER-positive, HER2-negative primary breast cancer with 0-3 involved lymph nodes. In combination with prior validation studies, this fully independent validation in ABCSG Trial 8 provides level 1B evidence for the prognostic capability of the OncoMasTR Risk Score.