Diagnostic capabilities of artificial intelligence as an additional reader in a breast cancer screening program

Objectives: We aimed to evaluate the early-detection capabilities of AI in a screening program over its duration, with a specific focus on the detection of interval cancers, the early detection of cancers with the assistance of AI from prior visits, and its impact on workload for various reading scenarios. Materials and methods: The study included 22,621 mammograms of 8825 women within a 10-year biennial two-reader screening program. The statistical analysis focused on 5136 mammograms from 4282 women due to data retrieval issues, among whom 105 were diagnosed with breast cancer. The AI software assigned scores from 1 to 100. Histopathology results determined the ground truth, and Youden’s index was used to establish a threshold. Tumor characteristics were analyzed with ANOVA and chi-squared test, and different workflow scenarios were evaluated using bootstrapping. Results: The AI software achieved an AUC of 89.6% (86.1–93.2%, 95% CI). The optimal threshold was 30.44, yielding 72.38% sensitivity and 92.86% specificity. Initially, AI identified 57 screening-detected cancers (83.82%), 15 interval cancers (51.72%), and 4 missed cancers (50%). AI as a second reader could have led to earlier diagnosis in 24 patients (average 29.92 ± 19.67 months earlier). No significant differences were found in cancer-characteristics groups. A hybrid triage workflow scenario showed a potential 69.5% reduction in workload and a 30.5% increase in accuracy. Conclusion: This AI system exhibits high sensitivity and specificity in screening mammograms, effectively identifying interval and missed cancers and identifying 23% of cancers earlier in prior mammograms. Adopting AI as a triage mechanism has the potential to reduce workload by nearly 70%. Clinical relevance statement: The study proposes a more efficient method for screening programs, both in terms of workload and accuracy. Key Points: • Incorporating AI as a triage tool in screening workflow improves sensitivity (72.38%) and specificity (92.86%), enhancing detection rates for interval and missed cancers. • AI-assisted triaging is effective in differentiating low and high-risk cases, reduces radiologist workload, and potentially enables broader screening coverage. • AI has the potential to facilitate early diagnosis compared to human reading.