Prosigna Breast Cancer Assay Now Approved for Reimbursement in Germany

Clinical Validation

 
 

Proven ability to add significant prognostic information beyond clinical factors

The prognostic significance of Prosigna was proven in the ABCSG-8 study, published in Annals of Oncology, 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.

ABCSG-8 Objectives1

  • 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% for the intermediate-risk group, and <85% for the high-risk group1
  • In node-positive patients, the 10-year DRFS rates were 94.2% for the low-risk group and 75.8% for the high-risk group1

References:
1. Prosigna [Package Insert]. Seattle, WA: NanoString Technologies, Inc.; 2013.
2. Gnant M, Filipits M, Greil R, et al; Austrian Breast and Colorectal Cancer Study Group. Predicting distant recurrence in receptor-positive breast cancer patients with limited clinicopathological risk: using the PAM50 Risk of Recurrence score in 1478 postmenopausal patients of the ABCSG-8 trial treated with adjuvant endocrine therapy alone. Ann Oncol. 2014;25(2):339-345.

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.