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

• Published in: Breast cancer (Tokyo, Japan) Japan), 2014-09, Vol.21 (5), p.583-589
• Main Authors: Wang, Yong-sheng, Liu, Yan-hui, Ou-yang, Tao, Yang, Xin-hua, Wu, Jiong, Su, Feng-xi, Sun, Xiao, Zhong, Wei-xia, Liao, Ning, Yang, Wen-tao
• Format: Article
• Language: English
• Subjects: Adult; Aged; Aged, 80 and over; Analysis; Book publishing; Breast Neoplasms - genetics; Breast Neoplasms - pathology; Breast Neoplasms - surgery; Cancer Research; Female; Frozen Sections - methods; Humans; Intraoperative Period; Lymphatic Metastasis - genetics; Lymphatic Metastasis - pathology; Medicine; Medicine & Public Health; Metastasis; Middle Aged; Oncology; Original Article; Prospective Studies; Real-Time Polymerase Chain Reaction - methods; Reproducibility of Results; Reverse Transcriptase Polymerase Chain Reaction - methods; Sensitivity and Specificity; Sentinel Lymph Node Biopsy - methods; Surgery; Surgical Oncology; Time Factors; Young Adult
• ISSN: 1340-6868; 1880-4233
• DOI: 10.1007/s12282-012-0437-z

Background Breast cancer sentinel lymph node (SLN) biopsy has become a common procedure. The GeneSearch™ 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-μm-thick sections were taken every 150 μm 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™ Breast Lymph Node Assay is an accurate and rapid intra-operative assay for breast SLNs and it can replace FS and TIC for application.