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

Mansel, Robert Edward ORCID: https://orcid.org/0000-0002-8051-0726, Goyal, Amit, Douglas-Jones, Anthony Gordon, Woods, Victoria, Goyal, Sumit, Monypenny, Ian, Sweetland, Helen Margaret, Newcombe, Robert Gordon ORCID: https://orcid.org/0000-0003-4400-8867 and Jasani, Bharat 2009. 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 115 (3) , pp. 595-600. 10.1007/s10549-008-0155-6

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Abstract

Background. 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. Methods 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 ~2 mm alternating node slabs and 3 additional sections cut at ~150 μm interval from each face of the node slab. Results 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 86.7–97.8%), positive predictive value of 66.7% (8/12, 95% CI 39.1–86.2%) and negative predictive value of 98.6% (69/70, 95% CI 92.3–99.7%). The assay was performed in a median time of 32 min (range 26–69 min). Conclusion Intra-operative assessment of sentinel lymph node can be performed rapidly and accurately using the GeneSearch™ BLN Assay.

Item Type:	Article
Date Type:	Publication
Status:	Published
Schools:	Medicine
Subjects:	R Medicine > RC Internal medicine > RC0254 Neoplasms. Tumors. Oncology (including Cancer)
Uncontrolled Keywords:	axillary lymph node dissection; breast cancer; intra-operative PCR; sentinel lymph node biopsy
Additional Information:	This work was presented at the 30th Annual San Antonio Breast Cancer Symposium December 13-16, 2007.
Publisher:	Kluwer
ISSN:	0167-6806
Last Modified:	18 Mar 2023 02:06
URI:	https://orca.cardiff.ac.uk/id/eprint/23257

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