To evaluate the accuracy of rapid on-site evaluation (ROSE) for intraoperative diagnosis of sentinel lymph node metastases in breast cancer.

According to the inclusion and exclusion criteria, a total of 195 breast cancer patients surgically treated in the Department Ⅱ of Breast Surgery, Yunnan Cancer Hospital from December 2019 to June 2021 were enrolled for a prospective study. During operation, sentinel lymph nodes were collected and examined by ROSE combined with rapid frozen-section pathology and the time needed was recorded respectively. The postoperative pathological result of paraffin section was used as the gold standard. After surgery, Papanicolaou staining and HE staining were performed for cytological confirmation of the diagnostic results. The diagnostic efficacy of ROSE was evaluated by McNemar test, Kappa consistency test and ROC curve, respectively. The diagnostic time for ROSE and intraoperative frozen-section pathology was compared by paired t-test.

A total of 444 sentinel lymph nodes were analyzed in this study and postoperative paraffin-section pathology (the gold standard) showed 42 nodes with metastasis (positive) and 402 without metastasis (negative). The sensitivity, specificity, accuracy, negative predictive value and positive predictive value of ROSE were 92.86% (39/42), 99.75% (401/402), 99.10% (440/444), 99.26% (401/404) and 97.50% (39/40), respectively. The Kappa test showed a high consistency between ROSE and paraffin-section pathology (Kappa=0.946, P<0.001) and the McNemar’s test showed no significant difference (χ²=397.848, P=0.625). The ROC curve showed that area under the curve (AUC) was 0.963 (95%CI: 0.918-1.000, P<0.001). Intraoperative frozen-section pathology showed 32 nodes with metastasis (positive) and 412 nodes without metastasis (negative). The Kappa test showed a high consistency between ROSE and intraoperative frozen-section pathology (Kappa=0.789, P<0.001) and the McNemar’s test showed no significant difference (χ²=280.228, P=0.057). The time for ROSE was (6.86±1.44) min, significantly lower than (35.46±2.42) min for intraoperative frozen-section pathology (t=-241.81, P<0.001). In cytology, the Kappa test showed a high consistency between HE staining and ROSE/Papanicolaou staining (Kappa=0.794, 0.796; both P<0.001).

ROSE has a high diagnostic efficacy in intraoperative assessment of sentinel lymph nodes status in breast cancer patients and it can reduce the time to diagnosis and treatment, with potential in clinical application.