Top

Published in:

01-07-2007 | Original Article

Comparison of automated silver enhanced in situ hybridisation (SISH) and fluorescence ISH (FISH) for the validation of HER2 gene status in breast carcinoma according to the guidelines of the American Society of Clinical Oncology and the College of American Pathologists

Authors: M. Dietel, I. O. Ellis, H. Höfler, H. Kreipe, H. Moch, A. Dankof, K. Kölble, G. Kristiansen

Published in: Virchows Archiv | Issue 1/2007

Abstract

HER2 is an important tumour marker in breast cancer. However, there is controversy regarding which method reliably measures HER2 status. This study evaluates the concordance between HER2 gene amplification in invasive breast cancer determined by fluorescence in situ hybridisation (FISH) and a new silver enhanced in situ hybridisation (SISH) technique. Ninety-nine cases were analysed by direct-labelled manual FISH (PathVysion®, Abbott/Vysis) and bright field automated SISH (INFORM®, Ventana). For comparison, all specimens were stained by immunohistochemistry (Dako-HercepTest™ and Ventana-PATHWAY®4B5). Evaluation was performed by five pathologists following the algorithms of the manufacturers and the American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines. Concordance was calculated and the value of κ statistics estimated. Overall concordance between FISH and SISH was 96.0% (κ = 0.754, 95%CI). Discrepancies were mostly seen in tumours with intra-tumoural heterogeneity of HER2 amplification. In conclusion, HER2 gene copy status can be reliably determined by SISH. The 96% concordance with FISH fulfils the ASCO/CAP requirement of greater than 95% concordance for amplified vs non-amplified cases. There was a low inter-observer variability in the interpretation of SISH, suggesting that SISH is equally reliable in determining HER2 amplification as FISH. Because SISH combines bright field microscopy with molecular analysis and full automation, it appears to be particularly suited for routine application in surgical pathology.

Cell Markers and Cytogenetics Committees College Of American Pathologists (2002) Clinical laboratory assays for HER-2/neu amplification and overexpression: quality assurance, standardization, and proficiency testing. Arch Pathol Lab Med 126:803–808

Akiyama T, Sudo C, Ogawara H, Toyoshima K, Yamamoto T (1986) The product of the human c-erbB-2 gene: a 185-kilodalton glycoprotein with tyrosine kinase activity. Science 232:1644–1646PubMedCrossRef

Bast RC Jr, Ravdin P, Hayes DF, Bates S, Fritsche H Jr, Jessup JM, Kemeny N, Locker GY, Mennel RG, Somerfield MR; American Society of Clinical Oncology Tumor Markers Expert Panel (2001) 2000 update of recommendations for the use of tumor markers in breast and colorectal cancer: clinical practice guidelines of the American Society of Clinical Oncology. J Clin Oncol 19:1865–1878PubMed

Cobleigh MA, Vogel CL, Tripathy D, Robert NJ, Scholl S, Fehrenbacher L, Wolter JM, Paton V, Shak S, Lieberman G, Slamon DJ (1999) Multinational study of the efficacy and safety of humanized anti-HER2 monoclonal antibody in women who have HER2-overexpressing metastatic breast cancer that has progressed after chemotherapy for metastatic disease. J Clin Oncol 17:2639–2648PubMed

Dietel M (2007) Predictive molecular pathology and the development of targeted therapy. In: Ochiai T, Shimada H, Tagawa M (eds) Gene therapy 2007. Medical View, Tokyo, pp 66–76

Dietel M, Sers C (2006) Personalized medicine and development of targeted therapies: the upcoming challenge for diagnostic molecular pathology. A review. Virchows Arch 448:744–755PubMedCrossRef

Dowsett M, Hanna WM, Kockx M, Penault-Llorca F, Ruschoff J, Gutjahr T, Habben K, van de Vijver MJ (2007) Standardization of HER2 testing: results of an international proficiency-testing ring study. Mod Pathol 20:584–591PubMedCrossRef

Ellis IO, Bartlett J, Dowsett M, Humphreys S, Jasani B, Miller K, Pinder SE, Rhodes A, Walker R (2004) Best Practice No 176: updated recommendations for HER2 testing in the UK. J Clin Pathol 57:233–237PubMedCrossRef

Fritzsche FR, Kristiansen G, Boesl A, Burkhardt M, Pahl S, Dankof A, Dietel M, Dahl E (2006) Tissue pretreatment with formic acid might lower HercepTest scores in breast cancer. Diagn Mol Pathol 15:237–242PubMedCrossRef

10.

Geyer CE, Forster J, Lindquist D, Chan S, Romieu CG, Pienkowski T, Jagiello-Gruszfeld A, Crown J, Chan A, Kaufman B, Skarlos D, Campone M, Davidson N, Berger M, Oliva C, Rubin SD, Stein S, Cameron D (2006) Lapatinib plus capecitabine for HER2-positive advanced breast cancer. N Engl J Med 355:2733–2743PubMedCrossRef

11.

Hanna W, O’Malley F (2002) Updated recommendations from the HER2/neu consensus meeting. Curr Oncol 9:S18–S19

12.

Kundel HL, Polansky M (2003) Measurement of observer agreement. Radiology 228:303–308PubMedCrossRef

13.

Paik S, Bryant J, Tan-Chiu E, Romond E, Hiller W, Park K, Brown A, Yothers G, Anderson S, Smith R, Wickerham DL, Wolmark N (2002) Real-world performance of HER2 testing—National Surgical Adjuvant Breast and Bowel Project experience. J Natl Cancer Inst 94:852–854PubMed

14.

Papouchado BG, Downs-Kelly E, Pestic-Dragovich L, Hood S, Pettay JD, Myles J et al (2007) Automated accelerated silver enhanced in situ hybridization (SISH) for detection of HER2 gene amplification in breast carcinoma. Virchows Arch (in press)

15.

Press MF, Bernstein L, Thomas PA, Meisner LF, Zhou JY, Ma Y, Hung G, Robinson RA, Harris C, El Naggar A, Slamon DJ, Phillips RN, Ross JS, Wolman SR, Flom KJ (1997) HER-2/neu gene amplification characterized by fluorescence in situ hybridization: poor prognosis in node-negative breast carcinomas. J Clin Oncol 15:2894–2904PubMed

16.

Press MF, Pike MC, Chazin VR, Hung G, Udove JA, Markowicz M, Danyluk J, Godolphin W, Sliwkowski M, Akita R et al (1993) Her-2/neu expression in node-negative breast cancer: direct tissue quantitation by computerized image analysis and association of overexpression with increased risk of recurrent disease. Cancer Res 53:4960–4970PubMed

17.

Rhodes A, Borthwick D, Sykes R, Al Sam S, Paradiso A (2004) The use of cell line standards to reduce HER-2/neu assay variation in multiple European cancer centers and the potential of automated image analysis to provide for more accurate cut points for predicting clinical response to trastuzumab. Am J Clin Pathol 122:51–60PubMedCrossRef

18.

Rhodes A, Jasani B, Anderson E, Dodson AR, Balaton AJ (2002) Evaluation of HER-2/neu immunohistochemical assay sensitivity and scoring on formalin-fixed and paraffin-processed cell lines and breast tumors: a comparative study involving results from laboratories in 21 countries. Am J Clin Pathol 118:408–417PubMedCrossRef

19.

Roche PC, Suman VJ, Jenkins RB, Davidson NE, Martino S, Kaufman PA, Addo FK, Murphy B, Ingle JN, Perez EA (2002) Concordance between local and central laboratory HER2 testing in the breast intergroup trial N9831. J Natl Cancer Inst 94:855–857PubMed

20.

Slamon DJ, Leyland-Jones B, Shak S, Fuchs H, Paton V, Bajamonde A, Fleming T, Eiermann W, Wolter J, Pegram M, Baselga J, Norton L (2001) Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. N Engl J Med 344:783–792PubMedCrossRef

21.

Wang S, Saboorian MH, Frenkel EP, Haley BB, Siddiqui MT, Gokaslan S, Wians FH Jr, Hynan L, Ashfaq R (2001) Assessment of HER-2/neu status in breast cancer. Automated Cellular Imaging System (ACIS)-assisted quantitation of immunohistochemical assay achieves high accuracy in comparison with fluorescence in situ hybridization assay as the standard. Am J Clin Pathol 116:495–503PubMedCrossRef

22.

Wolff AC, Hammond ME, Schwartz JN, Hagerty KL, Allred DC, Cote RJ, Dowsett M, Fitzgibbons PL, Hanna WM, Langer A, McShane LM, Paik S, Pegram MD, Perez EA, Press MF, Rhodes A, Sturgeon C, Taube SE, Tubbs R, Vance GH, van de Vijver M, Wheeler TM, Hayes DF (2007) American Society of Clinical Oncology/College of American Pathologists guideline recommendations for human epidermal growth factor receptor 2 testing in breast cancer. Arch Pathol Lab Med 131:18PubMed

23.

Yamauchi H, Stearns V, Hayes DF (2001) When is a tumor marker ready for prime time? A case study of c-erbB-2 as a predictive factor in breast cancer. J Clin Oncol 19:2334–2356PubMed

24.

Zarbo RJ, Hammond ME (2003) Conference summary, Strategic Science symposium. Her-2/neu testing of breast cancer patients in clinical practice. Arch Pathol Lab Med 127:549–553PubMed

Title: Comparison of automated silver enhanced in situ hybridisation (SISH) and fluorescence ISH (FISH) for the validation of HER2 gene status in breast carcinoma according to the guidelines of the American Society of Clinical Oncology and the College of American Pathologists
Authors: M. Dietel
I. O. Ellis
H. Höfler
H. Kreipe
H. Moch
A. Dankof
K. Kölble
G. Kristiansen
Publication date: 01-07-2007
Publisher: Springer-Verlag
Published in: Virchows Archiv / Issue 1/2007
Print ISSN: 0945-6317
Electronic ISSN: 1432-2307
DOI: https://doi.org/10.1007/s00428-007-0424-5

At a glance: The STEP trials

Springer Medicine

Comparison of automated silver enhanced in situ hybridisation (SISH) and fluorescence ISH (FISH) for the validation of HER2 gene status in breast carcinoma according to the guidelines of the American Society of Clinical Oncology and the College of American Pathologists

Abstract

At a glance: The STEP trials

Springer Medicine

Abstract

Please log in to get access to this content

Other articles of this Issue 1/2007

Epithelial atypia in biopsies performed for microcalcifications. Practical considerations about 2,833 serially sectioned surgical biopsies with a long follow-up

Response from authors of “Extracellular matrix alterations in conventional renal cell carcinomas by tissue microarray profiling influenced by the persistent, long-term, low-dose ionizing radiation exposure in humans”

Unexpected diagnosis of cystic fibrosis at liver biopsy: a report of four pediatric cases

CD30 and Epstein–Barr virus RNA expression in sclerosing angiomatoid nodular transformation of spleen

The spectrum of persistence of testicular blastema and ectopic testicular parenchyma: a possible result of focal delay in gonadal development

Hodgkin’s lymphoma in a patient with Jo-1 syndrome