乳腺癌前哨淋巴结手术中分子评估分析

Analysis of intraoperative molecular assessment of sentinel lymph nodes in breast carcinoma

【目的】评价GeneSearchTM乳腺淋巴结检测技术（简称Genesearch）在乳腺癌前哨淋巴结（SLN）转移评估中的可靠性及应用前景。【方法】对2010年5—8月北京大学第一医院、北京人民医院及卫生部北京医院共80例乳腺癌患者的140枚SLN，采用Genesearch法检测细胞角蛋白19和乳腺球蛋白的表达水平并对照冰冻和石蜡组织学结果进行评估。其中女性78例，男性2例，年龄29～85岁，中位年龄49岁。【结果】全部140枚SLN中，组织学诊断无肿瘤转移121枚，宏转移17枚，微转移2枚，未见孤立肿瘤细胞。Genesearch检测结果阴性119枚，阳性21枚，灵敏度为89.4%，特异度为96.7%，阳性预测值为81.0%（17/21），阴性预测值为98.3%（117/119），与组织学诊断的总符合率为95.7%。其中对宏转移的检测灵敏度为15/17，对微转移的检测灵敏度为2/2。【结论】Genesearch检测具有较高的灵敏度和特异度；技术操作应严格，避免假阳性和假阴性；对阳性结果不能分类可能是阻碍其广泛应用的关键。

Objective To evaluate the reliability and application of GeneSearchTM breast lymph node assay （Genesearch）, a real-time fluorescence quatitative PCR method, in intraoperative assay of metastasis in sentinel lymph nodes （SLNs） from breast cancer patients. Methods Totally 140 SLNs from 80 patients with breast carcinoma were prospectively studied from May 2010 to August 2010. The 80 patients included 78 women and 2 men who ranged in age from 29 to 85 years, and the median age is 49 years. The expression of CK19 and mammaglobulin in all 140 SLNs were detected by Genesearch, and the results were compared with that of histological evaluation of both frozen and paraffin-embedded sections. Results Among SLNs, by histological analyses, there were 121 without metastasis, 17 with macrometastasis, 2 with micrometastasis, and none of isolated tumor cell. By Geneseareh, there were 119 without metastasis and 21 with metastasis. Genesearch showed sensitivity of 89. 4%, positive predictive value of 81.0%, negative predictive value of 98.3% and specificity of 96. 7% by comparing to histological analyses. The concordance between Genesearch and histological analysis was 95.7%. The sensitivity of Genesearch was 15/17 for macrometastasis and 2/2 for micrometastasis. Conclusions Genesearch detection presents high sensitivity and specificity in evaluating metastasis of sentinel lymph nodes in breast cancer, but strict performance technically is necessary to avoid false positive and false negative results. Inability of further subtyping for the positive cases might be the key limitations for wide application of this method.