Validation of the Mirai model for predicting breast cancer risk in Mexican women.

ABSTRACT

OBJECTIVES: To validate the performance of Mirai, a mammography-based deep learning model, in predicting breast cancer risk over a 1-5-year period in Mexican women. METHODS: This retrospective single-center study included mammograms in Mexican women who underwent screening mammography between January 2014 and December 2016. For women with consecutive mammograms during the study period, only the initial mammogram was included. Pathology and imaging follow-up served as the reference standard. Model performance in the entire dataset was evaluated, including the concordance index (C-Index) and area under the receiver operating characteristic curve (AUC). Mirai's performance in terms of AUC was also evaluated between mammography systems (Hologic versus IMS). Clinical utility was evaluated by determining a cutoff point for Mirai's continuous risk index based on identifying the top 10% of patients in the high-risk category. RESULTS: Of 3110 patients (median age 52.6 years ± 8.9), throughout the 5-year follow-up period, 3034 patients remained cancer-free, while 76 patients developed breast cancer. Mirai achieved a C-index of 0.63 (95% CI 0.6-0.7) for the entire dataset. Mirai achieved a higher mean C-index in the Hologic subgroup (0.63 [95% CI 0.5-0.7]) versus the IMS subgroup (0.55 [95% CI 0.4-0.7]). With a Mirai index score > 0.029 (10% threshold) to identify high-risk individuals, the study revealed that individuals in the high-risk group had nearly three times the risk of developing breast cancer compared to those in the low-risk group. CONCLUSIONS: Mirai has a moderate performance in predicting future breast cancer among Mexican women. CRITICAL RELEVANCE STATEMENT Prospective efforts should refine and apply the Mirai model, especially to minority populations and women aged between 30 and 40 years who are currently not targeted for routine screening. KEY POINTS The applicability of AI models to non-White, minority populations remains understudied. The Mirai model is linked to future cancer events in Mexican women. Further research is needed to enhance model performance and establish usage guidelines.