Prognostic performance of an AI-based recurrence risk model in clinically low-risk HR+/HER2- early breast cancer

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Abstract Objective Accurate prognostication of recurrence risk in early breast cancer is central for therapeutic decision-making, including identifying patients who may safely avoid adjuvant therapy. Here we evaluate an artificial intelligence (AI)-based method to improve risk stratification. Methods Ataraxis Breast CTX (ATX) is an AI test that integrates H&E-stained images with clinicopathologic features to predict risk of recurrence for individual patients. This study validates ATX in a dataset of 892 clinically low-risk patients from Dordrecht, Netherlands. Of the 892 patients, 299 did not receive adjuvant therapy. The discriminative performance of ATX was assessed using C-index and its stratification ability was evaluated by log-rank tests. Results ATX achieved a C-index of 0.71 and a 5-year AUC of 0.71, demonstrating strong discrimination. Among 299 patients who received no adjuvant therapy, ATX achieved a C-index and AUC of 0.78 and 0.81 respectively. ATX scores were used to stratify patients into risk groups. Notably, untreated and treated ATX low-risk patients had comparable 5-year recurrence-free survival (RFS) (untreated: RFS = 96%, 95% CI = 92-97%; treated: RFS = 96%, 95% CI = 93-97%) with identical 10-year RFS (86%, 95% CI = 83-92% for both), suggesting ATX low-risk status may identify a subgroup with favorable prognosis independent of treatment. Conclusion ATX provides robust prognostic stratification in an external cohort and identifies a subgroup of patients who did not receive systemic therapy with favorable observed outcomes. These results support prospective validation of ATX as a decision-support tool for adjuvant therapy de-escalation in HR+/HER2- early breast cancer.

Ce résumé expose les affirmations des auteurs. BNTIC ne l’interprète pas comme une validation indépendante des résultats.