| Summary: | Objective: The aim of this study was to externally validate the feasibility and robustness of a risk-stratification score for B3 lesions based on clinical, pathological, and radiological data for improved clinical decision making. Methods: 129 consecutive histologically confirmed B3 lesions diagnosed at ultrasound-guided biopsy at our institution were included in this retrospective study. Patient- and lesion-related variables were independently assessed by two blinded breast radiologists (R1, R2), by assigning each feature a score from 0 to 2 (maximum sum-score of 5). Sensitivity, specificity, positive and negative predictive values were calculated at two different thresholds (≥1 and 2). Categorical variables were compared using Chi-squared and Fisher exact tests. The diagnostic accuracy of the score to distinguish benign from malignant B3 lesions was assessed by receiver operating characteristic (ROC) analysis. Results: Surgery was performed on 117/129 (90.6%) lesions and 11 of these 117 (9.4%) lesions were malignant. No cancers were found at follow-up of at least 24 months. Area under the ROC-curve was 0.736 (R1) to 0.747 (R2), with no significant difference between the two readers (p = 0.5015). Using a threshold of ≥1, a sensitivity, specificity, PPV, and NPV of 90%/90% (R1/R2), 39%/38% (R1/R2), 11%/12% (R1/R2) and 97%/98% (R1/R2) were identified. Both readers classified 47 lesions with a score ≤1 (low risk of associated malignancy). Of these, only one malignant lesion was underdiagnosed (Ductal carcinoma in situ-G1). Conclusions: In our external validation, the score showed a high negative predictive value and has the potential to reduce unnecessary surgeries or re-biopsies for ultrasound-detected B3-lesions by up to 39%.
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