title: The reliability of nipple aspirate and ductal lavage in women at increased risk for breast cancer--a potential tool for breast cancer risk assessment and biomarker evaluation.
abstract: OBJECTIVE
  Ductal lavage, a technique used to sample epithelial cells from breast ducts, has potential use in risk assessment and biomarker evaluation among women at increased risk for breast cancer. However, little is known about the reliability of the procedure.
  
  
  METHODS
  We evaluated the reliability of nipple aspirate (NAF) and ductal lavage at two time points 6 months apart in women at increased risk for breast cancer. Eligible women had a 5-year Gail risk >or=1.66% or lifetime risk of >20%, and/or a family history or personal history of breast cancer. All ducts that produced NAF were cannulated. The kappa statistic was used to evaluate reliability of NAF production, cellular yield, and cytologic diagnosis.
  
  
  RESULTS
  Sixty-nine women (mean age, 47 years) were enrolled over 35 months. Forty-seven returned for a second visit. At baseline, 65% of premenopausal and 41% of postmenopausal women produced NAF (P = 0.05), of which 72% underwent successful lavage of at least one duct. Samples of inadequate cellular material for diagnosis were significantly more likely in postmenopausal women than in premenopausal women (P = 0.04). Of the women who returned for a second visit, 18 of 24 who produced NAF had at least one duct successfully cannulated. Twenty-four ducts in 14 women were lavaged twice. Among these ducts, cellular yield for the two time points was inconsistent (kappa = 0.33 +/- 0.13), and only fair cytologic agreement was observed (kappa = 0.32 +/- 0.15). Ductal lavage was associated with moderate discomfort.
  
  
  CONCLUSIONS
  Currently, the use of ductal lavage is limited by technical challenges in duct cannulation, inconsistent NAF production, a high rate of inadequate cellular material for diagnosis, fair cytologic reproducibility, and low participant return rates.
authors.affiliation: Johns Hopkins Bloomberg School of Public Health, 615 North Wolfe Street, Baltimore, MD 21205, USA. kvisvana@jhsph.edu
authors.forename: K
authors.initials: K
authors.lastname: Visvanathan
authors.forename: D
authors.initials: D
authors.lastname: Santor
authors.forename: S Z
authors.initials: SZ
authors.lastname: Ali
authors.forename: A
authors.initials: A
authors.lastname: Brewster
authors.forename: A
authors.initials: A
authors.lastname: Arnold
authors.forename: D K
authors.initials: DK
authors.lastname: Armstrong
authors.forename: N E
authors.initials: NE
authors.lastname: Davidson
authors.forename: K J
authors.initials: KJ
authors.lastname: Helzlsouer
mesh_terms: D000465:Algorithms; D014408:Biomarkers, Tumor / Q000032:analysis*; D001940:Breast / Q000473:pathology*; D001943:Breast Neoplasms / Q000175:diagnosis / Q000473:pathology*; D003581:Cytodiagnosis / Q000379:methods / Q000592:standards*; D004847:Epithelial Cells / Q000473:pathology; D005260:Female; D006801:Humans; D008875:Middle Aged; D009558:Nipples / Q000378:metabolism* / Q000473:pathology; D015203:Reproducibility of Results; D018570:Risk Assessment; D007507:Therapeutic Irrigation
chemical_list: D014408:Biomarkers, Tumor