Document Type

Article

Publication Date

May 2007

Comments

This article has been peer-reviewed. It is the authors' final version prior to publication in The American Journal of Surgery 194(4):426-432, October 2007. The published version is available at http://dx.doi.org/10.1016/j.amjsurg.2007.07.008. Copyright © 2007 Excerpta Medica, Inc.

Abstract

BACKGROUND:
When sentinel node dissection reveals breast cancer metastasis, completion axillary lymph node dissection is ideally performed during the same operation. Intraoperative histologic techniques have low and variable sensitivity. A new intraoperative molecular assay (GeneSearch BLN Assay; Veridex, LLC, Warren, NJ) was evaluated to determine its efficiency in identifying significant sentinel lymph node metastases (>.2 mm).

METHODS:
Positive or negative BLN Assay results generated from fresh 2-mm node slabs were compared with results from conventional histologic evaluation of adjacent fixed tissue slabs.

RESULTS:
In a prospective study of 416 patients at 11 clinical sites, the assay detected 98% of metastases >2 mm and 88% of metastasis greater >.2 mm, results superior to frozen section. Micrometastases were less frequently detected (57%) and assay positive results in nodes found negative by histology were rare (4%).

CONCLUSIONS:
The BLN Assay is properly calibrated for use as a stand alone intraoperative molecular test.

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