title: Serum biomarkers to differentiate benign and malignant mammographic lesions.
abstract: BACKGROUND
  Mammographic screening has increased detection of earlier-stage breast cancers and has decreased mortality from breast cancer. A Breast Imaging-Reporting and Data System (BIRADS) 4 classification prompts a biopsy that most often reveals benign disease. Our objective was to determine if serum protein-expression profiles could be used to differentiate between benign and malignant mammographic lesions.
  
  
  METHODS
  After IRB approval, women undergoing an image-guided biopsy for a BIRADS category 4 lesion were recruited. Serum was collected prebiopsy and labeled retrospectively after final pathology was reviewed. Serum was incubated with weak cation exchange magnetic beads and assayed in duplicate for analysis on matrix-assisted laser desorption/ionization time-of-flight (MALDI-TOF) instrumentation (Bruker Daltonics). Spectra were analyzed using ClinProTools 2.0 software (Bruker Daltonics), and classifications determined using a genetic-clustering algorithm.
  
  
  RESULTS
  In a 14-month period, 260 subjects were recruited into this study. Sera from 92 subjects were randomly selected to form benign (n = 46) and cancer (n = 46) cohorts. The MALDI-TOF spectra analysis yielded 273 peaks, with 14 peaks expressed differentially (p < 0.05) between the cancer and benign cohorts. A genetic algorithm model was generated, yielding a sensitivity of 88.3% and specificity of 85.8%.
  
  
  CONCLUSIONS
  MALDI-TOF protein-expression profiles generated from BIRADS 4 sera could be used to distinguish between benign and malignant mammographic lesions.
authors.affiliation: Department of Surgery, Eastern Virginia Medical School, Norfolk, VA 23507, USA.
authors.forename: Susanna
authors.initials: S
authors.lastname: Shin
authors.forename: Lisa
authors.initials: L
authors.lastname: Cazares
authors.forename: Heather
authors.initials: H
authors.lastname: Schneider
authors.forename: Shamina
authors.initials: S
authors.lastname: Mitchell
authors.forename: Christine
authors.initials: C
authors.lastname: Laronga
authors.forename: O John
authors.initials: OJ
authors.lastname: Semmes
authors.forename: Roger R
authors.initials: RR
authors.lastname: Perry
authors.forename: Richard R
authors.initials: RR
authors.lastname: Drake
mesh_terms: D000465:Algorithms; D014408:Biomarkers, Tumor / Q000097:blood*; D001706:Biopsy; D001798:Blood Proteins / Q000032:analysis; D001943:Breast Neoplasms / Q000097:blood* / Q000473:pathology*; D016009:Chi-Square Distribution; D003937:Diagnosis, Differential; D005260:Female; D006801:Humans; D008327:Mammography; D008875:Middle Aged; D012189:Retrospective Studies; D012680:Sensitivity and Specificity
chemical_list: D014408:Biomarkers, Tumor; D001798:Blood Proteins