ABSTRACT
<p><b>BACKGROUND</b>Accurate intraoperative diagnosis of sentinel lymph node (SLN) metastases enables the selection of patients for axillary lymph node dissections during the same operation, reducing the need for a second operation. The present study aimed to prospectively compare the GeneSearch(TM) Breast Lymph Node (BLN) Assay with touch imprint cytology (TIC) for intraoperative evaluation of SLNs.</p><p><b>METHODS</b>SLNs were sectioned in 1.5 - 3.0 mm pieces. TIC was performed on all pieces and the BLN Assay and postoperative histology evaluations were performed on different alternating node pieces. Overall performance of the BLN Assay was compared with that of TIC relative to the postoperative histology results.</p><p><b>RESULTS</b>A total of 90 patients enrolled in the study. Complete intraoperative data for both the BLN Assay and TIC were collected in 86 patients. The sensitivity, specificity, and overall accuracy of the BLN Assay were 82%, 97%, and 92%, respectively on a per patient basis compared with those of TIC which were 67%, 100%, and 90%.</p><p><b>CONCLUSIONS</b>Performance of the BLN Assay was superior to that of TIC and the additional application of TIC did not help improve the total sensitivity and accuracy of the intraoperative assessment. The existence of ectopic breast tissue might be a possible cause of false positive for the BLN assay. In addition, the BLN Assay complements histopathology assessment and can minimize sampling error without increasing pathologists' workload.</p>
Subject(s)
Adult , Aged , Female , Humans , Male , Middle Aged , Cytodiagnosis , Methods , Intraoperative Period , Lymph Node Excision , Lymph Nodes , Lymphatic Metastasis , Diagnosis , Sentinel Lymph Node Biopsy , MethodsABSTRACT
<p><b>OBJECTIVE</b>to evaluate the application of GeneSearch(TM) breast lymph node assay in intraoperative detection of metastases in sentinel lymph node (SLN) from breast cancer patients.</p><p><b>METHODS</b>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 post-operative 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.</p><p><b>RESULTS</b>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).</p><p><b>CONCLUSIONS</b>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.</p>