Abstract
BACKGROUND: CanAssist Breast (CAB) is a prognostic test for early stage hormone receptor-positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) breast cancer patients, validated on Indian and Caucasian patients. The 21-gene signature Oncotype DX (ODX) is the most widely used commercially available breast cancer prognostic test. In the current study, risk stratification of CAB is compared with that done with ODX along with the respective outcomes of these patients. METHODS: A cohort of 109 early stage breast cancer patients who had previously taken the ODX test were retested with CAB, and the results respectively compared with old cut-offs of ODX as well as cut-offs suggested by TAILORx, a prospective randomized trial of ODX. Distant metastasis-free survival after 5 years was taken as the end point. RESULTS: CanAssist Breast stratified 83.5% of the cohort into low-risk and 16.5% into high-risk. With the TAILORx cut-offs, ODX stratified the cohort into 89.9% low-risk and 10.1% into high-risk. The low, intermediate, and high-risk groups with ODX old cut-offs were 62.4%, 31.2%, and 6.4%, respectively. The overall concordance of CAB with ODX using both cut-offs is 75%-76%, with ~82%-83% concordance in the low-risk category of these tests. The NPV of the low-risk category of CAB was 93.4%, and of ODX with TAILORx cut-offs was 91.8% and 89.7% with old cut-offs. CONCLUSIONS: Compared to the concordance reported for other tests, CAB shows high concordance with ODX, and in addition shows comparable performance in the patient outcomes in this cohort. CAB is thus an excellent and cost-effective alternative to ODX.