GeneSearch[TM] BLN Assay could replace frozen section and touch imprint cytology for intra-operative assessment of breast sentinel lymph nodes

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From: Breast Cancer(Vol. 21, Issue 5)
Publisher: Springer
Document Type: Report
Length: 393 words

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Byline: Yong-sheng Wang (1), Yan-hui Liu (2), Tao Ou-yang (3), Xin-hua Yang (4), Jiong Wu (5), Feng-xi Su (6), Xiao Sun (1), Wei-xia Zhong (1), Ning Liao (2), Wen-tao Yang (5) Keywords: Sentinel lymph node biopsy; Breast neoplasms; Intraoperative period; Polymerase chain reaction; Histological evaluation Abstract: Background Breast cancer sentinel lymph node (SLN) biopsy has become a common procedure. The GeneSearch[TM] Breast Lymph Node Assay is a real-time reverse-transcriptase polymerase chain reaction assay for detecting nodal metastases larger than 0.2 mm. The trial is a prospective multi-center clinical trial conducted to validate the assay in China. Methods Four hundred and seventy-nine consecutive prospective patients were enrolled from six centers. SLNs were sectioned along the short axis into multiple blocks. Odd blocks were tested by the assay intra-operatively, and even blocks were assessed by post-operative histology. Six 4- to 6-[micro]m-thick sections were taken every 150 [micro]m per block. In addition, intra-operative histological assessments were performed on the even blocks of 214 patients by frozen section (FS) and all blocks of 156 patients by touch imprint cytology (TIC). Results A total of 1046 SLNs were excised. Overall performance of the assay compared to post-operative histology was accuracy of 91.4 %, sensitivity of 87.5 %, and specificity of 92.9 %. There were no significant differences in assay performance of each center. After a learning curve of about 10 cases, the assay could be performed in a median time of about 35 min. The sensitivity of the assay was similar to the FS (84.9 %, P = 0.885) and was significantly higher than the TIC (70.0 %, P = 0.007) while the specificity of all were comparable. Conclusion The GeneSearch[TM] Breast Lymph Node Assay is an accurate and rapid intra-operative assay for breast SLNs and it can replace FS and TIC for application. Author Affiliation: (1) Breast Cancer Center, Shandong Cancer Hospital, 440 Jiyan Rd, Jinan, People's Republic of China (2) Breast Center, Guangdong General Hospital, Guangzhou, People's Republic of China (3) Breast Center, Beijing Cancer Hospital, Beijing, People's Republic of China (4) Breast Center, Southwest Hospital, Chongqing, People's Republic of China (5) Department of Breast Surgery, Shanghai Cancer Hospital, Shanghai, People's Republic of China (6) Department of Breast Surgery, The Second Affiliated Hospital of Sun Yat-sen University, Guangzhou, People's Republic of China Article History: Registration Date: 21/12/2012 Received Date: 27/07/2012 Accepted Date: 21/12/2012 Online Date: 16/01/2013

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Gale Document Number: GALE|A380104203