Prosigna clinical validation studies provide Level 1 evidence of clinical validity2
TransATAC and ABCSG-8 trials featured similar study designs and patient populations1
- The similar study designs enable combined analysis for a cumulative validation pool of >2400 patients
- Both studies analyzed samples from postmenopausal women with early-stage, hormone receptor–positive breast cancer who received 5 years of endocrine therapy after surgical resection of the primary tumor
- Studies included a total of 1786 node-negative patients and 688 node-positive patients, encompassing all risk groups and all 4 intrinsic subtypes
- The results of the validation studies constitute Level 1 evidence for clinical validity of the Prosigna test for predicting the risk of distant recurrence in postmenopausal women with hormone receptor–positive, early-stage breast cancer2
Prosigna provides prognostic information beyond that obtained from clinical and pathological variables1
Risk groups and prognosis
- Prosigna ROR is significantly correlated to 10-year distant recurrence (P<0.0001), and risk groups have different rates of DRFS in node-negative and node-positive patients
- The low-risk group had a 10-year risk of distant recurrence of <5%, while the high-risk group had a 10-year risk of distant recurrence of >20% in node-negative patients
Subtypes and prognosis
- Luminal A and luminal B subtypes have distinct prognostic outcomes, which impact systemic treatment considerations1,3
- The choice of systemic therapy should follow intrinsic subtype3
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. 3. Goldhirsch A, Wood WC, Coates AS, et al. Strategies for subtypes—dealing with the diversity of breast cancer: highlights of the St. Gallen International Expert Consensus on the Primary Therapy of Early Breast Cancer 2011. Ann Oncol. 2011;22(8):1736-1747.