Comprehensive Summary
The study by van Dooijeweert et al. presents the results of the CONFIDENT-B trial, a single-center, non-randomized prospective study evaluating the integration of artificial intelligence (AI) in detecting sentinel lymph node metastases in early breast cancer patients. The trial involved 190 sentinel lymph node specimens from 182 patients, randomly assigned to either an AI-assisted or standard pathologist review arm. The AI tool used, Visiopharm's Metastasis Detection app, highlighted potentially metastatic areas on digital H&E slides to assist pathologists in determining the necessity of additional immunohistochemistry (IHC). Results indicated that AI significantly reduced IHC use per metastatic case (adjusted relative risk = 0.68) without compromising diagnostic safety. AI-assisted diagnoses demonstrated higher sensitivity (60%) and negative predictive value (88.2%) compared to the unaided pathologist approach. Additionally, detection rates for micrometastases and isolated tumor cells improved with AI, and slide review times were reduced. Pathologists rated the tool highly for usability, and cost savings were estimated at 3,000 € during the trial, with potential for greater savings in broader implementation.
Outcomes and Implications
This research is significant as sentinel lymph node assessment is crucial for breast cancer staging and treatment planning, yet traditionally it is time-consuming and resource-intensive. AI-assisted pathology offers a scalable, cost-effective approach that maintains high diagnostic accuracy while reducing reliance on IHC. As digital pathology infrastructure expands, tools like the Visiopharm app could become integral to clinical workflows, especially in high-volume cancer centers. The study suggests that with appropriate training and validation, AI tools can streamline diagnostic processes, reduce labor demands, and enhance early detection. Widespread implementation could realistically occur within 2–4 years, contingent on regulatory approvals and institutional investment in digital systems.