CanAssist breast: An affordable breast cancer prognostic test validated on Asian patients.

Abstract

541 Background: Treatment decisions for early stage HR+/HER2neu- breast cancer patients in the West routinely depend on prognostic tests that predict risk of recurrence. However, such tests are rarely used in Asia due to prohibitive costs and lack of validation data on Asian patients. Chemotherapy is thus often a default treatment leading to physiological and financial toxicity. To address these, we have developed CanAssist Breast (CAB) as an affordable IHC-based prognostic test, retrospectively validated on ~1400 patients, 63% South Asians and rest Caucasians. To date CAB has been prescribed by 180+ doctors across 30 cities in India for ~600 patients in clinics, enabling personalized treatment decisions. Methods: Primary surgical FFPE blocks and clinical follow-up data were obtained from hospitals. GraphPad Prism and MedCalc were respectively used for Kaplan-Meier survival analyses and Cox logistic regression to calculate hazard ratios. Results: The median age of diagnosis in the validation cohort was 56 years, 63% patients with stage II disease and 60% node negative tumors. Distant Metastasis Free Survival (DMFS) in the low-risk category of the validation cohort was 95%, and 84% in high-risk (P < 0.0001). Similar results were obtained with the Caucasian subgroup, as also with the chemotherapy-naive subgroup (30% of the cohort), demonstrating that risk stratification by CAB is unaffected by race or chemotherapy. Next, the performance of CAB was compared with Oncotype DX (ODX). 83% patients stratified as low risk by ODX (RS 0-25) in a sub-cohort of 109 were also stratified as low-risk by CAB. To assess the impact of CAB in treatment decision making, we assessed the data of 589 patients who have undergone CAB testing so far, 288 were identified as low-risk. 93% of these CAB low-risk patients were not given chemotherapy, demonstrating the clinical impact of CAB. Conclusions: CAB is the first test of its kind to be retrospectively validated in Asia. It shows high concordance with ODX in risk stratification of patients. CAB has been in clinical practice in India and near-India markets for 2 years and is helping clinicians and patients in making affordable treatment decisions.

Practical Consensus Recommendations for Optimizing Risk versus Benefit of Chemotherapy in Patients with HR Positive Her2 Negative Early Breast Cancer in India

“…Fortunately, CanAssist Breast is a tool that has been prospectively validated in Indian patients and results published in full-text articles in international journals of repute. 61 62 63 64 CanAssist Breast data has also been compared to Oncotype DX, Mammaprint, Ki67, and IHC4 65 …”

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“…Fortunately, CanAssist Breast is a tool that has been prospectively validated in Indian patients and results published in full-text articles in international journals of repute. [61][62][63][64] CanAssist Breast data has also been compared to Oncotype DX, Mammaprint, Ki67, and IHC4 65 Besides robust data from Indian patients, other key advantages of CanAssist Breast include clear-cut division into two risk categories (no intermediate group) and its applicability to all patients, irrespective of their age or menopausal status. In fact, real-world data consist of 589 patients from 30 cities across India treated by 180 oncologists.…”

Choosing Wisely – Implication based on Indian data in our patients with breast cancer (INR vs. USD)

“…In addition to clinical features, the only biomarker test studied sufficiently in Indian patients is CanAssist Breast. [21,22] As per ICMR guidelines, in routine clinical practice, we should only use tests that have been validated in Indian patients. [23] This is because there is center.…”