乳腺癌前哨淋巴结术中分子诊断的临床实用性初探

目的 探讨GeneSearchTM乳腺淋巴结检测试剂盒(以下简称GeneSearch)在乳腺癌前哨淋巴结(SLN)术中诊断的临床实用性.方法 对复旦大学附属肿瘤医院2009年2月至6月诊治的88例乳腺癌患者行SLN活检.首先垂直长轴将所得淋巴结切成数块厚约2 mm的组织块,对各切面进行术中细胞印片后,奇数号组织块用于术后连续切片检查,偶数号组织块采用GeneSearch进行检测,应用即时荧光定量逆转录聚合酶链反应检测SLN中CK19和乳腺球蛋白表达的Ct值.将GeneSearch以术后连续切片的诊断为准,与术中细胞印片、术后连续切片的病理结果分别进行比较.结果 88例共获得225枚SLN,其中宏转移淋巴结27枚,微转移淋巴结9枚,阴性淋巴结189枚(其中5枚为孤立肿瘤细胞).从切割淋巴结开始到最终形成报告,GeneSearch耗时范围为35～45 min(平均40 min).基于淋巴结数目,GeneSearch与术后连续切片的总体符合率为95.6%(215/225),其检测敏感度为86.1%(31/36),均高于术中细胞印片分别为94.7%(213/225)和72.2%(26/36)].SLN转移灶大小与CKl9和乳腺球蛋白的Ct值存在统计学相关性(P＜0.01).结论 GeneSearch用于SLN术中诊断时,其检测敏感度高于术中细胞印片,达到比较满意的效果,但在应用中仍存在一些问题.

Evaluation of intraoperative molecular assay in sentinel lymph node biopsy from breast cancer patients

Objective To evaluate the application of GeneSearchTM breast lymph node assay in intraoperative detection of metastases in sentinel lymph node (SLN) from breast cancer patients. Methods A total of 225 SLN from 88 patients was prospectively studied. Each SLN was cut into 2 mm slabs which were examined by intraoperative imprint cytology (ⅡC) first, followed by GeneSearch assay and postoperative serial sectioning. GeneSearch used real-time fluorescence quantitative RT-PCR technology to detect the expression of CK19 and mammaglobin in SLN. The results of GeneSearch assay were correlated with those of ⅡC and post-operative serial sectioning. Results Amongst the 88 cases studied, 225 SLNs were found, and obvious metastatic carcinoma cells were identified in 27 SLNs and micrometastasis in 9 SLNs.One hundred and eight-nine SLNs were considered as "negative" (with "isolated tumor cells" present in 5 SLNs). The turn-around time of intraoperative GeneSearch assay ranged from 35 to 45 minutes (mean = 40 minutes). The concordance rate between GeneSearch assay and post-operative serial sectioning was 95.6% (215/225), with a sensitivity of 86.1% (31/36), compared with 94.7% (213/225) and 72.2% (26/36)respectively for ⅡC. The size of metastatic foci correlated with the Ct value of CK19 and mammaglobin (P ＜0.01). Conclusions GeneSearch assay for intraoperative detection of metastase in SLN has a satisfactory performance and demonstrates a relatively higher sensitivity than ⅡC. The potential clinical application still requires further evaluation of larger number of cases.