Current molecular risk stratification tests have helped clinicians to optimize Chemotherapy for early stage breast cancer patients leading to huge savings in treatment costs and improved quality of life. However, current tests are not impactful in the Asia due to the extreme cost-sensitivity of the market. Aim of this study was to develop and validate a cost-effective, broad based and robust test to stratify early stage hormone receptor positive patients based on individual risk of recurrence.
A retrospective cohort of 300 patients, was used to develop ‘CanAssist-Breast’- a Morphometric Immunohistochemistry based test comprising 5 biomarkers plus three clinical parameters (Tumor size, node status and grade) using SVM based algorithm. CanAssist-Breast biomarkers belong to key signaling pathways involved tumor invasion and chemotherapy resistance.
CanAssist-Breast classifies patients into ‘low or high’ risk of recurrence based on “CanAssist-Breast Score” score. Test validation in a 800+ sample cohort demonstrated that it is useful in both node negative and positive patients, as well as chemotherapy naïve and treated patients. CanAssist-Breast Score, is a strong independent predictor of disease recurrence by multivariate analysis. The majority of patients in ‘low risk’ had Stage 2, Grade 2/3 disease over Stage 1, Grade 1 disease. Comparison with commonly used prognostic tools including Ki67, the online tool PREDICT and Oncotype Dx showed that CanAssist-Breast test was superior in determining prognosis.
CanAssist-Breast is a low-cost, prognostic and chemotherapy predictive test to predict risk of recurrence and enable optimal treatment planning in patients with early stage Breast Cancer in Asia.
Clinical trial identification
Legal entity responsible for the study
DCGI registered Ethical Committee based in Bangalore, India.
Onco Stem Diagnostics Private Limited
M.M. Bakre: OncoStem Diagnostics is start-up biotechnology company privately funded by venture capitalist. The retrospective, non-interventional, observational study was approved by DCGI registered Ethical Committee based in Bangalore, India. All other authors have declared no conflicts of interest.