Abstract
INTRODUCTION: Current management of oral potentially malignant disorders (OPMDs) based on dysplasia grading is controversial. The malignant transformation rate of OPMDs does not correlate well with dysplasia grading, resulting in non-standardized treatment for patients. A quantitative biomarker-based risk score (qBRS; trade name StraticyteTM) was previously developed to address shortcomings related to the current standard of care. A multicenter, retrospective cohort study consisting of biopsied OPMDs was used to validate qBRS for predicting transformation of OPMDs to OSCC. MATERIALS & METHODS: Three hundred and two cases were immunostained, imaged, and analyzed via qBRS. A binary prognostic risk was determined using a receiver operating characteristic curve optimizing sensitivity and specificity. Kaplan-Meier analysis was used to estimate the cumulative probability of lack of malignant transformation for patients with elevated or normal biomarker-based risk. RESULTS: The results demonstrated very high sensitivity (96.2%) and negative predictive value (96.2%) for qBRS. Elevated risk scores had higher predicted probabilities of transformation to cancer, independent of dysplasia grade. CONCLUSIONS: qBRS can be a useful clinical adjunct tool to dysplasia grading for the assessment of malignant transformation potential, providing a quantitative metric in OPMDs. The addition of qBRS to current histological techniques should improve early detection rates of OSCC, enhancing the effectiveness of treatment.