Development and validation of an artificial intelligence-based pipeline for predicting oral epithelial dysplasia malignant transformation

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Abstract
Background: Oral epithelial dysplasia (OED) is a potentially malignant histopathological diagnosis given to lesions of the oral cavity that are at risk of progression to malignancy. Manual grading of OED is subject to substantial variability and does not reliably predict prognosis, potentially resulting in sub-optimal treatment decisions. Method: We developed a Transformer-based artificial intelligence (AI) pipeline for the prediction of malignant transformation from whole-slide images (WSIs) of Haematoxylin and Eosin (H&E) stained OED tissue slides, named ODYN (Oral Dysplasia Network). ODYN can simultaneously classify OED and assign a predictive score (ODYN-score) to quantify the risk of malignant transformation. The model was trained on a large cohort using three different scanners (Sheffield, 358 OED WSIs, 105 control WSIs) and externally validated on cases from three independent centres (Birmingham and Belfast, UK, and Piracicaba, Brazil; 108 OED WSIs). Results: Model testing yielded an F1-score of 0.96 for classification of dysplastic vs non-dysplastic slides, and an AUROC of 0.73 for malignancy prediction, gaining comparable results to clinical grading systems. Conclusions: With further large-scale prospective validation, ODYN promises to offer an objective and reliable solution for assessing OED cases, ultimately improving early detection and treatment of oral cancer.
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