Comparison of visual and automated assessment of HER2 status and their impact on outcome in primary operable invasive ductal breast cancer

• Published in: Histopathology Vol. 61; no. 4; pp. 675 - 684
• Main Authors: Mohammed, Zahra M A, Going, James J, McMillan, Donald C, Orange, Clare, Mallon, Elizabeth, Doughty, Julie C, Edwards, Joanne
• Format: Journal Article
• Language: English
• Published: Oxford, UK Blackwell Publishing Ltd 01-10-2012; Blackwell; Wiley Subscription Services, Inc
• Subjects: automated IHC method; Biological and medical sciences; Breast Neoplasms - metabolism; Breast Neoplasms - mortality; Breast Neoplasms - pathology; Carcinoma, Ductal, Breast - metabolism; Carcinoma, Ductal, Breast - mortality; Carcinoma, Ductal, Breast - pathology; Disease-Free Survival; Female; Gynecology. Andrology. Obstetrics; HER2 FISH test; Humans; Image Processing, Computer-Assisted - methods; Immunohistochemistry; In Situ Hybridization, Fluorescence; Investigative techniques, diagnostic techniques (general aspects); Mammary gland diseases; Medical sciences; Middle Aged; Pathology. Cytology. Biochemistry. Spectrometry. Miscellaneous investigative techniques; primary invasive breast cancer; Receptor, ErbB-2 - analysis; survival; Tissue Array Analysis; Tumors; visual IHC method; Breast disease; Prognosis; automated IHC method; erbB2 Gene; Exploration; Breast cancer; Malignant tumor; Method; Survival; Human Epidermal growth factor Receptor 2; HER2 FISH test; Mammary gland diseases; Anatomic pathology; visual IHC method; C-Onc gene; Fluorescence in situ hybridization; Evolution; Invasive cancer; Automatic analysis; Comparative study; Protooncogene; Cancer; Primary cancer; primary invasive breast cancer; survival
• ISSN: 0309-0167; 1365-2559
• DOI: 10.1111/j.1365-2559.2012.04280.x

Mohammed Z M A, Going J J, McMillan D C, Orange C, Mallon E, Doughty J C & Edwards J 
(2012) Histopathology 61, 675–684
Comparison of visual and automated assessment of HER2 status and their impact on outcome in primary operable invasive ductal breast cancer
Aims:  To compare visual and computerized image analysis of HER2 immunohistochemistry (IHC) with fluorescence in‐situ hybridization (FISH) for HER2 status, and to examine the relationships with outcome in patients with primary operable invasive ductal breast cancer.
Methods and results:  Tissue microarrays for 431 breast cancer patients were used to compare different approaches to the assessment of HER2 status. The cores were scored visually and with the Slidepath Tissue IA system, using the NICE‐approved scoring system for the HercepTest, as well as by FISH. The agreement between visual and image analysis of HER2 IHC was excellent [interclass correlation coefficient (ICCC) = 0.95, rs = 0.90, r = 0.91, k = 0.81, and P < 0.001]. The agreement of HER2 FISH with visual and image analysis of HER2 IHC was also excellent (ICCC = 0.95 and ICCC = 0.92, respectively). Univariate survival analysis showed equivalent associations of visual and image analysis of HER2 and HER2 FISH with both recurrence‐free survival (all P < 0.01) and cancer‐specific survival (all P < 0.05) in patients with invasive ductal breast cancer.
Conclusions:  Computerized image analysis of HER2 IHC gives results comparable to those obtained with visual assessment, with possible advantages in diagnostic pathology.