Department of Health Science, School of Medicine, University of Eastern Piedmont "Amedeo Avogadro", Novara, Italy.
Department of Medical Sciences, University of Turin, Turin, Italy.
J Clin Pathol. 2014 Aug;67(8):702-6. doi: 10.1136/jclinpath-2014-202384. Epub 2014 Jun 6.
Cytokeratin 19 (CK19) mRNA copy number predicts the probability of tumour load in axillary lymph nodes (ALN) and can help in decision-making regarding the axillary dissection. The purpose of this study was to define a new cut-off of CK19 mRNA copy number using the one-step nucleic acid amplification (OSNA) assay on metastatic sentinel lymph nodes (SLN) in order to identify cases at risk of having one or more positive ALN.
1296 SLN from 1080 patients were analysed with the OSNA assay. 194 patients with positive SLN underwent ALN dissection and the mean value of CK19 copy number (320 000) of their SLN was set as initial cut-off. Receiver operative characteristics curve identify a best cut-off of 7700 (sensitivity 78%, specificity 57%). A comparison between our and the traditional cut-off (5000) was performed.
The cut-off of 7700 successfully identifies patients with positive ALN (p=0.001, false- negative cases: 17%). In the range between 5000 and 7700, one patient with positive ALN would not undergo axillary dissection, whereas eight patients with negative ALN would be correctly identified.
We suggest that the level of CK19 mRNA copy number could be the only parameter to consider in the intraoperative management of the axilla.
细胞角蛋白 19（CK19）mRNA 拷贝数可预测腋窝淋巴结（ALN）的肿瘤负荷概率，并有助于决策是否进行腋窝清扫。本研究的目的是使用一步法核酸扩增（OSNA）检测转移性前哨淋巴结（SLN）来定义 CK19 mRNA 拷贝数的新截断值，以识别具有一个或多个阳性 ALN 风险的病例。
分析了 1080 例患者的 1296 个 SLN，使用 OSNA 检测。194 例阳性 SLN 患者行 ALN 清扫术，其 SLN 的 CK19 拷贝数平均值（320000）设定为初始截断值。受试者工作特征曲线确定最佳截断值为 7700（敏感性 78%，特异性 57%）。比较了我们的截断值和传统截断值（5000）。
7700 的截断值成功识别出阳性 ALN 患者（p=0.001，假阴性病例：17%）。在 5000 至 7700 范围内，一个 ALN 阳性的患者将不会接受腋窝清扫术，而 8 个 ALN 阴性的患者将被正确识别。
我们建议 CK19 mRNA 拷贝数水平可以成为腋窝术中管理的唯一考虑因素。
