Value of intraoperative GeneSearch(TM) BLN assay to detect breast cancer metastases in sentinel lymph nodes / 中华肿瘤杂志

<p><b>OBJECTIVE</b>To evaluate the value of GeneSearch(TM) BLN assay as an intraoperative diagnostic method of sentinel lymph node metastases in breast cancer patients.</p><p><b>METHODS</b>Ninety consecutive patients were involved in this study. SLNs were intraoperatively identified and dissected, and then sectioned vertically to the long axis into multiple blocks. The odd blocks were tested by BLN assay and even ones prepared for frozen sectioning (FS), while all blocks were evaluated by touch imprint cytology (TIC). Post-operatively, residual tissues of the even blocks were assessed by histopathologic examination (4 - 6 µm thick serial sectioning permanent H&E slides were performed every 150 µm and one block made 6 slides).</p><p><b>RESULTS</b>BLN assay could be performed within less than 35 min after learning curve of 10 cases. A correlation was found between cycle time values of mammaglobin or cytokeratin-19 and size of metastases, with Spearman correlation coefficients of 0.67 and 0.71, respectively. The accuracy, sensitivity, specificity, positive predict value (PPV) and negative predict value (NPV) of the assay were 95.6%, 93.3%, 96.7%, 93.3% and 96.7%, While FS had the sensitivity, specificity, PPV, NPV of 76.7%, 100%, 100%, 89.6%, and TIC of 73.3%, 100%, 100%, 88.2%, respectively. The sensitivity of the assay was higher than that of FS (P = 0.07), and was significantly higher than that of FS (P = 0.04). When assessing patients with micro-metastases, the assay had a sensitivity of 85.7%, which was significantly higher than that of FS and TIC (P = 0.03).</p><p><b>CONCLUSION</b>GeneSearch(TM) BLN Assay can replace FS and TIC for the intraoperative assessment of SLN.</p>

Using intra-operative GeneSearchTM Breast Lymph Node Assay to detect breast cancer metastases in sentinel lymph nodes: results from a single institute in China / 中华医学杂志(英文版)

<p><b>BACKGROUND</b>Sentinel lymph node (SLN) biopsy has become a common procedure for early breast cancer patients. The GeneSearch(TM) Breast Lymph Node (BLN) Assay is a real-time RT-PCR assay for the detecting nodal metastases larger than 0.2 mm. China Breast Cancer Clinical Study Group (CBCSG)-001a is a prospective multi-center clinical trial that was conducted to validate the GeneSearch(TM) BLN Assay in China.</p><p><b>METHODS</b>The SLNs from 90 consecutive patients were identified and dissected, and then sectioned along the short axis into multiple blocks. Intra-operatively, the odd blocks were tested by BLN assay and the even ones were used for frozen section, while all the blocks were evaluated by touch imprint cytology. Post-operatively, the remaining tissues were assessed by histological evaluation.</p><p><b>RESULTS</b>A total of 189 SLNs was tested by BLN assay. The sensitivity, specificity, positive predictive value, and negative predictive value were 88.9%, 97.4%, 88.9% and 97.4%, respectively, for BLN assay, 75.0%, 100%, 100% and 94.4%, respectively, for frozen section, and 63.9%, 100%, 100% and 92.2%, respectively, for touch imprint cytology. The sensitivity of BLN assay was higher than that of touch imprint cytology (P = 0.01) and frozen section (P = 0.13). When assessing the nodes with micro-metastases, BLN assay had a significant higher sensitivity than frozen section (P = 0.023) and touch imprint cytology (P = 0.005).</p><p><b>CONCLUSION</b>The GeneSearch(TM) BLN Assay is an accurate and rapid intra-operative assay for breast SLNs and it is suitable for application in general medical practice.</p>