摘要
目的探讨现场快速评估(ROSE)技术应用于术中诊断乳腺癌前哨淋巴结转移的准确性。方法根据纳入、排除标准,入组2019年12月至2021年6月在云南省肿瘤医院乳腺外二科行手术治疗的乳腺癌患者195例进行前瞻性研究。术中将收集的前哨淋巴结应用ROSE技术联合快速冰冻切片病理检查进行诊断,同时分别记录ROSE与冰冻切片病理检查的诊断时间,以术后石蜡切片为临床金标准。术后另行巴氏染色和HE染色,对诊断结果进行细胞学准确性验证。使用McNemar检验、Kappa一致性检验、受试者工作特征(ROC)曲线评价ROSE技术的诊断效能,ROSE技术与术中快速冰冻切片病理检查的诊断时间采用配对t检验进行对比分析。结果本研究共分析了444枚前哨淋巴结,以术后石蜡切片结果为临床病理金标准,其显示前哨淋巴结(SLN)癌转移(阳性)共42枚,未见癌转移(阴性)共402枚。ROSE技术对比金标准的敏感度和特异度分别为92.86%(39/42)和99.75%(401/402),准确率为99.10%(440/444),阴性预测值和阳性预测值分别为99.26%(401/404)和97.50%(39/40)。ROSE技术对比石蜡切片的Kappa一致性检验结果较好(Kappa=0.946,P<0.001);McNemar检验结果显示二者检查结果差异无统计学意义(χ^(2)=397.848,P=0.625);ROC曲线显示曲线下面积(AUC)为0.963(95%CI:0.918~1.000,P<0.001)。术中冰冻切片病理检查显示SLN癌转移(阳性)共32枚,未见癌转移(阴性)共412枚。ROSE技术对比术中冰冻切片病理检查的Kappa一致性检验结果很好(Kappa=0.789,P<0.001),McNemar检验结果显示二者差异无统计学意义(χ^(2)=280.228,P=0.057)。ROSE诊断时间为(6.86±1.44)min,术中冰冻切片病理检查时间为(35.46±2.42)min,差异有统计学意义(t=-241.81,P<0.001)。在细胞学方面,ROSE技术、巴氏染色分别与HE染色比较的一致性检验结果较好(Kappa=0.794、0.796,P均<0.001)。结论ROSE技术术中评估乳腺癌前哨淋巴结状态具有较高的诊断效能,且缩短了诊断时间,具有一定的临床应用价值。
Objective To evaluate the accuracy of rapid on-site evaluation(ROSE)for intraoperative diagnosis of sentinel lymph node metastases in breast cancer.Methods According to the inclusion and exclusion criteria,a total of 195 breast cancer patients surgically treated in the DepartmentⅡof 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.Results 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(χ^(2)=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(χ^(2)=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).Conclusion 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.
作者
李惠
晋萍
张祥武
郭瑢
黄胜
唐一吟
周绍强
陈德滇
汤琦
Li Hui;Jin Ping;Zhang Xiangwu;Guo Rong;Huang Sheng;Tang Yiyin;Zhou Shaoqiang;Chen Dedian;Tang Qi(DepartmentⅡof Breast Surgery,Yunnan Cancer Hospital,Kunming 650118,China;Department of Pathology,Yunnan Cancer Hospital,Kunming 650118,China;Department of Cardiothoracic Surgery,Yunnan Cancer Hospital,Kunming 650118,China)
出处
《中华乳腺病杂志（电子版）》
CAS
CSCD
2023年第1期6-12,共7页
Chinese Journal of Breast Disease(Electronic Edition)
基金
国家自然科学基金资助项目(81860465)
云南省教育厅科学研究基金项目(2020J0195)
云南省高层次卫生计生技术人才-后备人才项目(H201704)
云南省教育厅科学研究基金项目(2023Y0652)。
关键词
乳腺肿瘤
前哨淋巴结
现场快速评估
Breast neoplasms
Sentinel lymph node
Rapid on-site evaluation
作者简介
通信作者:汤琦,Email:20089962@qq.com。
