Background: Accurate assessment of axillary lymph node status is important for breast cancer staging and treatment. Sonography can detect metastatic lymph nodes with varying degrees of sensitivity and specificity, while its routine use in the preoperative assessment of axillary lymph nodes remains controversial. The aim of this study was to assess the diagnostic accuracy of pretreatment axillary sonography in our clinical setting and to determine whether sonographic evaluation of the axilla as a tool for regional staging of breast cancer should be performed routinely in all cases. Methods: The study recruited 185 women with histologically confirmed breast cancer from September 2021 to December 2022. Axillary ultrasound was performed on all patients to assess lymph node status using predetermined criteria. The ultrasound findings were compared to the histopathology results. Results: Axillary sonography had 94.1% sensitivity, 87.7% specificity, 95.5% positive predictive value, 96.0% negative predictive value, and 92.4% accuracy in detecting metastatic lymph nodes in newly diagnosed breast cancer patients. In comparison to benign axillae, malignant axillae were significantly more likely to meet the lymph node criteria for "lobulated or irregular margin," "round or irregular shape," "focal or eccentric cortical thickening ≥3 mm," "totally replaced cortex," and "non-hilar blood flow" (p < 0.001). Conclusions: Pretreatment sonography of the axilla had a high accuracy rate and a good outcome in the evaluation of lymph node status in newly diagnosed breast cancer patients, and it should be performed routinely in all cases. Trial registration: Not applicable
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