Detection of breast cancer metastasis in sentinel lymph nodes using intra-operative real time GeneSearch BLN Assay in the operating room: results of the Cardiff study

Breast Cancer Research and Treatment
Robert E ManselBharat Jasani

Abstract

Intra-operative assessment is not routinely performed in the UK due to poor sensitivity of available methods and overburdened pathology resources. We conducted a prospective clinical feasibility study of the GeneSearch Breast Lymph Node (BLN) Assay (Veridex, LLC, Warren, NJ) to confirm its potential usefulness within the UK healthcare system. In the assay 50% of the lymph node was processed to detect the presence of cytokeratin-19 and mammaglobin mRNA. The assay was calibrated to detect metastases >0.2 mm. Assay results were compared to H&E performed on each face of approximately 2 mm alternating node slabs and 3 additional sections cut at approximately 150 microm interval from each face of the node slab. 124 sentinel lymph nodes were removed from 82 breast cancer patients. The assay correctly identified all 6 patients with sentinel node macrometastases (>2.0 mm), and 2 of 3 patients with sentinel node micrometastases (0.2-2.0 mm). Sentinel lymph nodes in 4 patients were assay positive but histology negative. Two of these four patients had isolated tumor cells seen by histology. The overall concordance with histology was 93.9% (77/82), with sensitivity of 88.9% (8/9, 95% CI 56.5-98%), specificity of 94.6% (69/73, 95% CI 86.7-97...Continue Reading

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Citations

Dec 1, 2009·The Indian Journal of Surgery·Amit Goyal
Jan 17, 2013·Breast Cancer : the Journal of the Japanese Breast Cancer Society·Yong-sheng WangWen-tao Yang
Jan 15, 2010·Magyar onkologia·Zsófia PénzváltóBalázs Gyorffy
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Apr 9, 2009·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·Yasuhiro TamakiNariaki Matsuura

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