title: Serum proteomic analysis identifies a highly sensitive and specific discriminatory pattern in stage 1 breast cancer.
abstract: BACKGROUND
  Mass spectrometry (MS)-based profiling was used to determine whether ion fingerprints could distinguish women with stage 1 breast cancer from women without breast cancer.
  
  
  METHODS
  The initial study population consisted of 310 subjects: 155 women with yearly negative breast examination and negative mammography findings for at least 4 years, and 155 women undergoing surgery for pathology-proven stage 1 invasive ductal carcinoma. High-resolution SELDI-TOF (surface-enhanced laser desorption ionization-time of flight) analysis was performed on serum obtained from blood samples collected before mammography in controls, and before surgery in patients with breast cancer. Samples were divided into a training (109 controls and 109 cancers) and blinded (46 controls and 46 cancers) testing set; each group had similar age demographics. In addition, an independent study set of 46 serum samples was analyzed 14 months after the initial study to validate the robustness of the classifier.
  
  
  RESULTS
  A discriminatory profile consisting of seven ion peaks found in the training set, when applied to the blinded test set, achieved a sensitivity and specificity of 95.6% and 86.5%, respectively. This same seven-peak profile achieved a 96.5% sensitivity and 85.7% specificity, with correct identification of all of 17 T1a tumors when applied to the validation study set.
  
  
  CONCLUSIONS
  Mass spectrometry profiling of human serum generated a robust classifier composed of seven low-molecular-weight ions that yielded a highly sensitive and specific diagnostic procedure for the discrimination of women with stage 1 breast cancer compared with women without breast cancer in this research study set.
authors.affiliation: Department of Surgery, CRO-IRCCS, National Cancer Institute, Via Franco Gallini, 2, 33081 Aviano (PN), Italy. cbelluco@cro.it
authors.forename: Claudio
authors.initials: C
authors.lastname: Belluco
authors.forename: Emanuel F
authors.initials: EF
authors.lastname: Petricoin
authors.forename: Enzo
authors.initials: E
authors.lastname: Mammano
authors.forename: Francesco
authors.initials: F
authors.lastname: Facchiano
authors.forename: Sally
authors.initials: S
authors.lastname: Ross-Rucker
authors.forename: Donato
authors.initials: D
authors.lastname: Nitti
authors.forename: Cosimo
authors.initials: C
authors.lastname: Di Maggio
authors.forename: Chenwei
authors.initials: C
authors.lastname: Liu
authors.forename: Mario
authors.initials: M
authors.lastname: Lise
authors.forename: Lance A
authors.initials: LA
authors.lastname: Liotta
authors.forename: Gordon
authors.initials: G
authors.lastname: Whiteley
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D014408:Biomarkers, Tumor / Q000097:blood; D001943:Breast Neoplasms / Q000097:blood* / Q000473:pathology; D005260:Female; D006801:Humans; D008875:Middle Aged; D009363:Neoplasm Proteins / Q000097:blood*; D009367:Neoplasm Staging; D040901:Proteomics / Q000379:methods*; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D019032:Spectrometry, Mass, Matrix-Assisted Laser Desorption-Ionization
chemical_list: D014408:Biomarkers, Tumor; D009363:Neoplasm Proteins