title: Comparison of visual and automated assessment of Ki-67 proliferative activity and their impact on outcome in primary operable invasive ductal breast cancer.
abstract: BACKGROUND
  Immunohistochemistry of Ki-67 protein is widely used to assess tumour proliferation, and is an established prognostic factor in breast cancer. There is interest in automating the assessment of Ki-67 labelling index (LI) with possible benefits in handling increased workload, with improved accuracy and precision.
  
  
  METHODS
  Visual and automated assessment of Ki-67 LI and survival were examined in patients with primary operable invasive ductal breast cancer. Tissue microarrays (n=379 patients) immunostained for Ki-67 were scored visually and automatically with the Slidepath Tissue IA system.
  
  
  RESULTS
  Visual and automated Ki-67 LI were in excellent agreement (ICCC=0.96, P<0.001). On univariate analysis, visual (P<0.001) and automated Ki67 LI (P<0.05) were associated with cancer-specific survival in patients with invasive ductal breast cancer overall and in patients who received endocrine therapy (Tamoxifen) (P<0.01 for visual and P<0.05 for automated scoring).
  
  
  CONCLUSIONS
  Automated assessment of Ki-67 LI would appear to be comparable to visual Ki-67 LI. However, automated Ki-67 LI assessment was inferior in predicting cancer survival in patients with breast cancer, including patients who received Tamoxifen.
authors.affiliation: Academic Unit of Surgery, College of Medical, Veterinary and Life of Sciences- University of Glasgow, Royal Infirmary, Glasgow G31 2ER, UK. z.mohammed.1@research.gla.ac.uk
authors.forename: Z M A
authors.initials: ZM
authors.lastname: Mohammed
authors.forename: D C
authors.initials: DC
authors.lastname: McMillan
authors.forename: B
authors.initials: B
authors.lastname: Elsberger
authors.forename: J J
authors.initials: JJ
authors.lastname: Going
authors.forename: C
authors.initials: C
authors.lastname: Orange
authors.forename: E
authors.initials: E
authors.lastname: Mallon
authors.forename: J C
authors.initials: JC
authors.lastname: Doughty
authors.forename: J
authors.initials: J
authors.lastname: Edwards
mesh_terms: D001331:Automation; D001943:Breast Neoplasms / Q000473:pathology* / Q000601:surgery; D018270:Carcinoma, Ductal, Breast / Q000473:pathology* / Q000601:surgery; D049109:Cell Proliferation; D005260:Female; D006801:Humans; D007150:Immunohistochemistry; D019394:Ki-67 Antigen / Q000378:metabolism*; D008875:Middle Aged; D009361:Neoplasm Invasiveness; D016896:Treatment Outcome; D014785:Vision, Ocular
chemical_list: D019394:Ki-67 Antigen