Clinical validation of a molecular assay for intra-operative detection of metastases in breast sentinel lymph nodes
| Autor: | Denis Larsimont, Pierre Bourgeois, Dina Hertens, Maria Dolores Martin Martinez, Laurence Lespagnard, Jean Christophe Schobbens, Francesco Feoli, Isabelle Veys, Ghizlane Rouas, V. Filippov, Samira Majjaj, Jean-Marie Nogaret, Virginie Durbecq, Danièle Noterman |
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| Rok vydání: | 2008 |
| Předmět: |
medicine.medical_specialty
Pathology Axillary lymph nodes Sentinel lymph node Breast Neoplasms Sensitivity and Specificity Breast cancer Mammaglobin Predictive Value of Tests medicine Biomarkers Tumor Humans Uteroglobin Prospective Studies Lymph node Keratin-19 Frozen section procedure Intraoperative Care biology business.industry Reverse Transcriptase Polymerase Chain Reaction Sentinel Lymph Node Biopsy Carcinoma Mammaglobin A Histology General Medicine Middle Aged medicine.disease Neoplasm Proteins medicine.anatomical_structure Oncology Lymphatic Metastasis Axilla biology.protein Lymph Node Excision Surgery Female Lymph Radiology Lymph Nodes business |
| Zdroj: | European journal of surgical oncology : the journal of the European Society of Surgical Oncology and the British Association of Surgical Oncology. 35(4) |
| ISSN: | 1532-2157 |
| Popis: | Background In breast cancer patients, the status of the sentinel lymph nodes (SLNs) has been shown to accurately reflect the presence of metastases in the axillary lymph nodes (ALNs). Intra-operative SLN evaluation by frozen section histology may miss positive cases, leading to a second surgery for complete ALN dissection. Permanent section histology itself has tissue sampling limitations and is partially dependent on pathologist expertise. Methods A prospective study ( N =78) was conducted in our institution to validate a new intra-operative molecular assay, the GeneSearch™ breast lymph node (BLN) assay. This assay quantifies the expression of mammaglobin and cytokeratin-19 genes using quantitative RT-PCR technology to determine SLN status. Fresh SLN sections (2mm thick) were analyzed alternatively by BLN assay or post-operative histology (haematoxylin–eosin and immunohistochemistry). The subject was considered positive when histology revealed a focus >0.2mm. Results BLN assay results corroborated with histologic results in 75 out of 78 patients for an overall agreement of 96%, a sensitivity of 92%, and a specificity of 97%. The positive and negative predictive values of the BLN assay were of 86% (12/14) and 98% (63/64), respectively. Interestingly, a statistically significant correlation was observed between the metastases' histologic size and both assay markers' expression levels as represented by cycle time to positivity ( ρ ≥0.71, all p Conclusions The performance of the BLN assay in identifying nodal metastases >0.2mm was similar to that of permanent section histology, with the added advantages of an objective and rapid output that could be used for intra-operative decision to remove additional ALN. |
| Databáze: | OpenAIRE |
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