title: Whole sentinel lymph node analysis by a molecular assay predicts axillary node status in breast cancer.
abstract: BACKGROUND
  The one-step nucleic acid amplification (OSNA) assay is a rapid procedure for the detection of lymph node (LN) metastases using molecular biological techniques. The aim of this study was to assess the reliability of the whole sentinel lymph node (SLN) analysis by the OSNA assay as a predictor of non-SLN metastases.
  
  
  METHODS
  Consecutive 742 patients with breast cancer were enroled in the study. The association of non-SLN or ≥4 LN metastases with clinicopathological variables was investigated using multivariate logistic analysis.
  
  
  RESULTS
  In total, 130 patients with a positive SLN who underwent complete axillary LN dissection were investigated. The frequency of non-SLN metastases in patients who were OSNA+ and ++ was 19.3% and 53.4%, respectively, and that in patients with ≥4 LN metastases who were OSNA+ and ++ was 7.0% and 27.4%, respectively. The cytokeratin 19 (CK19) mRNA copy number (≥5.0 × 10(3); OSNA++) in the SLN was the most significant predictors of non-SLN metastases (P=0.003). The CK19 mRNA copy number (≥1.0 × 10(5)) in the SLN was the only independent predictor of ≥4 LN metastases (P=0.014).
  
  
  CONCLUSIONS
  Whole SLN analysis using the OSNA assay could become a valuable method for predicting non-SLN and ≥4 LN metastases.
authors.affiliation: Department of Pathology, Sagara Hospital, Social Medical Corporation Hakuaikai, Matsubaracho, Kagoshima, Japan. y_ohi@sagara.or.jp
authors.forename: Y
authors.initials: Y
authors.lastname: Ohi
authors.forename: Y
authors.initials: Y
authors.lastname: Umekita
authors.forename: Y
authors.initials: Y
authors.lastname: Sagara
authors.forename: Y
authors.initials: Y
authors.lastname: Rai
authors.forename: D
authors.initials: D
authors.lastname: Yotsumoto
authors.forename: A
authors.initials: A
authors.lastname: Matsukata
authors.forename: S
authors.initials: S
authors.lastname: Baba
authors.forename: S
authors.initials: S
authors.lastname: Tamada
authors.forename: Y
authors.initials: Y
authors.lastname: Matsuyama
authors.forename: M
authors.initials: M
authors.lastname: Ando
authors.forename: Y
authors.initials: Y
authors.lastname: Sagara
authors.forename: M
authors.initials: M
authors.lastname: Sasaki
authors.forename: S
authors.initials: S
authors.lastname: Tsuchimochi
authors.forename: A
authors.initials: A
authors.lastname: Tanimoto
authors.forename: Y
authors.initials: Y
authors.lastname: Sagara
mesh_terms: D001365:Axilla / Q000473:pathology*; D001943:Breast Neoplasms / Q000235:genetics* / Q000473:pathology; D005260:Female; D006801:Humans; D053539:Keratin-19 / Q000235:genetics*; D008198:Lymph Nodes / Q000473:pathology*; D008207:Lymphatic Metastasis; D008875:Middle Aged; D021141:Nucleic Acid Amplification Techniques; D011237:Predictive Value of Tests; D012333:RNA, Messenger; D015203:Reproducibility of Results; D012189:Retrospective Studies; D021701:Sentinel Lymph Node Biopsy
chemical_list: D053539:Keratin-19; D012333:RNA, Messenger