title: Prognostic markers in breast cancer: the reliability of HER2/neu status in core needle biopsy of 325 patients with primary breast cancer.
abstract: BACKGROUND
  The assessment of HER2/neu overexpression in tissue provides information about one of the most relevant prognostic and predictive markers in breast cancer: overexpression of HER2/neu is associated with worse prognosis in primary breast cancer. Since core needle biopsy is increasingly used for the diagnosis of breast cancer, the purpose of this study was to assess the reliability of HER2/neu evaluation using this technique in patients with primary breast cancer.
  
  
  METHODS
  We investigated the accuracy of immunohistochemical assessment of HER2/neu in core needle biopsies compared with surgically obtained specimens in 325 patients with primary breast cancer. In patients strongly positive for HER2/neu, additional fluorescence in situ hybridization (FISH) analysis of needle biopsies was performed.
  
  
  RESULTS
  Using immunohistochemistry alone, accuracy of HER2/neu assessment in core biopsies in relation to surgically removed specimens was 92% and increased to 96% with additional FISH analysis (weighted Kappa coefficient: 0.86).
  
  
  CONCLUSIONS
  As proven with this large series of patients, the assessment of HER2/neu status by core needle biopsy in breast cancer is accurate. Notwithstanding, in order to minimize the number of false-positive results, strongly positive core needle biopsies identified using immunohistochemistry should be confirmed by FISH analysis.
authors.affiliation: Department of Surgery, Vienna University Medical School, Vienna, Austria. susanne.taucher@univie.ac.at
authors.forename: Susanne
authors.initials: S
authors.lastname: Taucher
authors.forename: Margaretha
authors.initials: M
authors.lastname: Rudas
authors.forename: Robert M
authors.initials: RM
authors.lastname: Mader
authors.forename: Michael
authors.initials: M
authors.lastname: Gnant
authors.forename: Peter
authors.initials: P
authors.lastname: Dubsky
authors.forename: Sebastian
authors.initials: S
authors.lastname: Roka
authors.forename: Thomas
authors.initials: T
authors.lastname: Bachleitner
authors.forename: Daniela
authors.initials: D
authors.lastname: Kandioler
authors.forename: Günther
authors.initials: G
authors.lastname: Steger
authors.forename: Martina
authors.initials: M
authors.lastname: Mittlböck
authors.forename: Raimund
authors.initials: R
authors.lastname: Jakesz
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000911:Antibodies, Monoclonal / Q000627:therapeutic use; D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents / Q000627:therapeutic use; D001707:Biopsy, Needle; D001940:Breast / Q000473:pathology; D001943:Breast Neoplasms / Q000188:drug therapy / Q000235:genetics* / Q000473:pathology / Q000601:surgery; D044584:Carcinoma, Ductal / Q000188:drug therapy / Q000235:genetics* / Q000473:pathology / Q000601:surgery; D018275:Carcinoma, Lobular / Q000188:drug therapy / Q000235:genetics* / Q000473:pathology / Q000601:surgery; D002886:Chromosomes, Human, Pair 17; D003131:Combined Modality Therapy; D005260:Female; D005819:Genetic Markers / Q000235:genetics*; D006801:Humans; D017404:In Situ Hybridization, Fluorescence; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D011237:Predictive Value of Tests; D011379:Prognosis; D011933:Reagent Kits, Diagnostic; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000235:genetics*; D000068878:Trastuzumab
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents; D005819:Genetic Markers; D011933:Reagent Kits, Diagnostic; D018719:Erb-b2 Receptor Tyrosine Kinases; D000068878:Trastuzumab