title: Comparative evaluation of an extensive histopathologic examination and a real-time reverse-transcription-polymerase chain reaction assay for mammaglobin and cytokeratin 19 on axillary sentinel lymph nodes of breast carcinoma patients.
abstract: OBJECTIVE
  To assess the accuracy of a commercially available real-time reverse-transcription-polymerase chain reaction assay for mammaglobin and cytokeratin 19 mRNAs [GeneSearch Breast Lymph Node (BLN) Assay, Veridex LLC, Warren, NJ] in the detection of axillary sentinel lymph nodes (SLNs) metastases in patients with breast carcinoma.
  
  
  BACKGROUND
  Because of the lack of standardized and widely accepted protocols for a truly accurate histopathologic examination of SLN, the relative merits of alternative assays based on the identification of tumor specific mRNA markers deserve further assessment.
  
  
  METHODS
  : A prospective series of 293 consecutive SLNs from 293 patients was evaluated. The BLN assay results were compared with those of an extensive histopathologic examination of the entire SLNs performed on serial frozen sections cut at 40 to 50 microm intervals.
  
  
  RESULTS
  The BLN assay correctly identified 51 of 52 macrometastatic and 5 of 20 micrometastatic SLNs, with a sensitivity of 98.1% to detect metastases larger than 2 mm, 94.7% for metastases larger than 1 mm, and 77.8% for metastases larger than 0.2 mm. The overall concordance with histopathology was 90.8%, with specificity of 95.0%, positive predictive value of 83.6%, and negative predictive value of 92.9%. When the results were evaluated according to the occurrence of additional metastases to non-SLN in patients with histologically positive SLNs, the assay was positive in 33 (91.7%) of the 36 patients with additional metastases and in 22 (66.6%) of the 33 patients without further echelon involvement.
  
  
  CONCLUSIONS
  The sensitivity of the reverse-transcription -polymerase chain reaction assay is comparable to that of the histopathologic examination of the entire SLN by serial sectioning at 1.5 to 2 mm.
authors.affiliation: Department of Pathology and Laboratory Medicine, European Institute of Oncology, Via Ripamonti 435, 20141 Milan, Italy. giuseppe.viale@ieo.it
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Viale
authors.forename: Patrizia
authors.initials: P
authors.lastname: Dell'Orto
authors.forename: Maria O
authors.initials: MO
authors.lastname: Biasi
authors.forename: Viviana
authors.initials: V
authors.lastname: Stufano
authors.forename: Luciana N
authors.initials: LN
authors.lastname: De Brito Lima
authors.forename: Giovanni
authors.initials: G
authors.lastname: Paganelli
authors.forename: Patrick
authors.initials: P
authors.lastname: Maisonneuve
authors.forename: Janet M
authors.initials: JM
authors.lastname: Vargo
authors.forename: George
authors.initials: G
authors.lastname: Green
authors.forename: Wuxiong
authors.initials: W
authors.lastname: Cao
authors.forename: Ailsa
authors.initials: A
authors.lastname: Swijter
authors.forename: Giovanni
authors.initials: G
authors.lastname: Mazzarol
mesh_terms: D014408:Biomarkers, Tumor / Q000235:genetics / Q000378:metabolism; D001943:Breast Neoplasms / Q000235:genetics / Q000378:metabolism / Q000473:pathology*; D005260:Female; D006801:Humans; D053539:Keratin-19 / Q000235:genetics / Q000378:metabolism*; D008198:Lymph Nodes / Q000737:chemistry / Q000378:metabolism / Q000473:pathology*; D008207:Lymphatic Metastasis; D060785:Mammaglobin A; D009363:Neoplasm Proteins / Q000235:genetics / Q000378:metabolism*; D011237:Predictive Value of Tests; D011446:Prospective Studies; D020133:Reverse Transcriptase Polymerase Chain Reaction; D012680:Sensitivity and Specificity; D021701:Sentinel Lymph Node Biopsy; D014598:Uteroglobin / Q000235:genetics / Q000378:metabolism*
chemical_list: D014408:Biomarkers, Tumor; D053539:Keratin-19; D060785:Mammaglobin A; D009363:Neoplasm Proteins; C556448:SCGB2A2 protein, human; D014598:Uteroglobin