The value of computer aided detection system FOR mammography in the breast cancer screening: single-center, prospective, randomized clinical trial

Purpose. To assess the influence of mammography mapping with the help of computer-aided detection system (CAD) MammCheck II of our own design on the relapse-free survival (RFS) in breast cancer (BC) patients detected during the combined (mammographic and ultrasound [US]) screening. Materials and methods. 10732 women aged 40-87 years old (mean age: 52.20±8.63) who performed mammography were randomized to the standard screening group (mammography → US of the dense breasts) or to the group of CAD-assisted screening (mammography → CAD → targeted US of suspicious CAD markings, as well as the standard US of the dense breasts; CAD group). The primary endpoint was the 3-years RFS. Results. Totally, in the standard screening group we identified 230 BCs (4.29%), in the CAD group — 248 BCs (4.62%; p>0.05), including 49 (21.20%) и 88 (35.48%) 0-I stage BCs, respectively (p<0.05). Median of the primary tumor size was significantly lower in the CAD group (18 mm) compared to the standard screening group (25 mm; р<0.05). 3-years RFS was significantly higher (87.90%) in the CAD group compared to the standard screening group (81.20%; р<0.05). Conclusion. Breast US after the previous mammography CAD mapping significantly increases the 3-years RFS of women with combined screening-detected BC.