The prognostic significance of Prosigna was proven in the ABCSG-8 study, which consisted of more than 1400 patient samples1.
- Study cohort consists of formalin-fixed paraffin-embedded (FFPE) breast tumor tissue samples retrospectively collected and archived in the Austrian Breast & Colorectal Cancer Study Group (ABCSG) tumor bank from patients enrolled in the ABCSG-8 trial1.
- Postmenopausal women with hormone receptor-positive breast cancer were randomized prior to treatment to 2 years of adjuvant tamoxifen followed by either 3 years of anastrozole or 3 years of adjuvant tamoxifen1,2.
- Re-consented >1200 patients2.
- Clinical treatment score (CTS) was derived from standard clinical covariates, including age, grade, tumor size, nodal status, and adjuvant therapy1.
- Determine whether the Prosigna Score adds prognostic information beyond the CTS.
- Determine whether the Prosigna Score-based risk groups of low, intermediate, and high add prognostic information beyond the CTS.
Get more prognostic information beyond standard clinical variables
- Both the Prosigna Score and risk group add statistically significant prognostic information beyond the CTS (P<0.0001)1,2
- In node-negative patients, the 10-year distant recurrence-free survival (DRFS) rates were >95% for the low-risk group, 90.4%
forthe intermediate-risk group, and <85% forthe high-risk group1
- In node-positive patients, the 10-year DRFS rates were 94.2% for the low-risk group and 75.8%
forthe high-risk group1
Prosigna is indicated for in vitro diagnostic use in postmenopausal women with hormone receptor-positive, node-negative (Stage I or II), or node-positive (Stage II) breast cancer to be treated with adjuvant endocrine therapy for assessment of risk of distant recurrence of disease.