Prospective Multi-centre Study to Validate Chromogenic in Situ Hybridisation for the Assessment of HER2 Gene Amplification in Specimens from Adjuvant and Metastatic Breast Cancer Patients

Overview

Journal J Cancer Res Clin Oncol

Specialty Oncology

Date 2010 Apr 17

PMID 20396915

Citations 1

Authors

Sabine Riethdorf

Bernhard Hoegel

Birgit John

German Ott

Peter Fritz

Susanne Thon

Thomas Loening

Klaus Pantel

Affiliations

Soon will be listed here.

Abstract

Purpose: As HER2 status is a strong predictor of the response to trastuzumab, clinical guidelines recommend that all breast tumours are first evaluated for HER2 protein expression by immunohistochemistry (IHC) followed by confirmatory testing for HER2 gene amplification using fluorescence in situ hybridisation (FISH) for 2+ cases. Alternatively, chromogenic in situ hybridisation (CISH) offers a simpler, less expensive approach to detect HER2 amplification.

Methods: In this prospective, multi-centre study, based on the largest dataset for HER2 testing in Germany to date, we evaluated the concordance between FISH and CISH in 399 samples from adjuvant and metastatic breast cancer patients. Tumour specimens from routine diagnostic practice were analysed by IHC, FISH and CISH in four reference centres.

Results: FISH and CISH results were strongly concordant (κ = 0.83), with 95% of cases showing agreement. Despite variable IHC scoring across testing centres, complete consensus among the three methods was observed for 246 cases, representing 91% of all IHC positive (3+) or negative (0/1+) cases. Confirmatory testing of 132 IHC equivocal (2+) cases also yielded highly concordant results between FISH and CISH.

Conclusions: These data validate CISH for the assessment of HER2 gene amplification in breast tumours and, confirm CISH as a valid alternative to FISH in HER2 testing.

Citing Articles

Chromogenic in situ hybridization compared with other approaches to evaluate HER2/neu status in breast carcinomas.

Rosa F, Santos R, Rogatto S, Domingues M Braz J Med Biol Res. 2013; 46(3):207-16.

PMID: 23558859 PMC: 3854374. DOI: 10.1590/1414-431x20132483.

References

van de Vijver M, van de Bersselaar R, Devilee P, Cornelisse C, Peterse J, Nusse R . Amplification of the neu (c-erbB-2) oncogene in human mammmary tumors is relatively frequent and is often accompanied by amplification of the linked c-erbA oncogene. Mol Cell Biol. 1987; 7(5):2019-23. PMC: 365313. DOI: 10.1128/mcb.7.5.2019-2023.1987. View

Slamon D, Clark G, Wong S, Levin W, Ullrich A, McGuire W . Human breast cancer: correlation of relapse and survival with amplification of the HER-2/neu oncogene. Science. 1987; 235(4785):177-82. DOI: 10.1126/science.3798106. View

Tapia C, Glatz K, Novotny H, Lugli A, Horcic M, Seemayer C . Close association between HER-2 amplification and overexpression in human tumors of non-breast origin. Mod Pathol. 2007; 20(2):192-8. DOI: 10.1038/modpathol.3800729. View

Vincent-Salomon A, MacGrogan G, Couturier J, Arnould L, Denoux Y, Fiche M . Calibration of immunohistochemistry for assessment of HER2 in breast cancer: results of the French multicentre GEFPICS study. Histopathology. 2003; 42(4):337-47. DOI: 10.1046/j.1365-2559.2003.01598.x. View

Vocaturo A, Novelli F, Benevolo M, Piperno G, Marandino F, Cianciulli A . Chromogenic in situ hybridization to detect HER-2/neu gene amplification in histological and ThinPrep-processed breast cancer fine-needle aspirates: a sensitive and practical method in the trastuzumab era. Oncologist. 2006; 11(8):878-86. DOI: 10.1634/theoncologist.11-8-878. View

Yaziji H, Goldstein L, Barry T, Werling R, Hwang H, Ellis G . HER-2 testing in breast cancer using parallel tissue-based methods. JAMA. 2004; 291(16):1972-7. DOI: 10.1001/jama.291.16.1972. View

Mass R, Press M, Anderson S, Cobleigh M, Vogel C, Dybdal N . Evaluation of clinical outcomes according to HER2 detection by fluorescence in situ hybridization in women with metastatic breast cancer treated with trastuzumab. Clin Breast Cancer. 2005; 6(3):240-6. DOI: 10.3816/CBC.2005.n.026. View

Menard S, Valagussa P, Pilotti S, Gianni L, Biganzoli E, Boracchi P . Response to cyclophosphamide, methotrexate, and fluorouracil in lymph node-positive breast cancer according to HER2 overexpression and other tumor biologic variables. J Clin Oncol. 2001; 19(2):329-35. DOI: 10.1200/JCO.2001.19.2.329. View

Arnould L, Denoux Y, MacGrogan G, Penault-Llorca F, Fiche M, Treilleux I . Agreement between chromogenic in situ hybridisation (CISH) and FISH in the determination of HER2 status in breast cancer. Br J Cancer. 2003; 88(10):1587-91. PMC: 2377115. DOI: 10.1038/sj.bjc.6600943. View

10.

Jimenez R, Wallis T, Tabasczka P, Visscher D . Determination of Her-2/Neu status in breast carcinoma: comparative analysis of immunohistochemistry and fluorescent in situ hybridization. Mod Pathol. 2000; 13(1):37-45. DOI: 10.1038/modpathol.3880007. View

11.

Lal P, Tan L, Chen B . Correlation of HER-2 status with estrogen and progesterone receptors and histologic features in 3,655 invasive breast carcinomas. Am J Clin Pathol. 2005; 123(4):541-6. DOI: 10.1309/YMJ3-A83T-B39M-RUT9. View

12.

Isola J, Tanner M, Forsyth A, Cooke T, Watters A, Bartlett J . Interlaboratory comparison of HER-2 oncogene amplification as detected by chromogenic and fluorescence in situ hybridization. Clin Cancer Res. 2004; 10(14):4793-8. DOI: 10.1158/1078-0432.CCR-0428-03. View

13.

Romond E, Perez E, Bryant J, Suman V, Geyer Jr C, Davidson N . Trastuzumab plus adjuvant chemotherapy for operable HER2-positive breast cancer. N Engl J Med. 2005; 353(16):1673-84. DOI: 10.1056/NEJMoa052122. View

14.

Hauser-Kronberger C, Dandachi N . Comparison of chromogenic in situ hybridization with other methodologies for HER2 status assessment in breast cancer. J Mol Histol. 2004; 35(6):647-53. DOI: 10.1007/s10735-004-2186-6. View

15.

Gong Y, Sweet W, Duh Y, Greenfield L, Fang Y, Zhao J . Chromogenic in situ hybridization is a reliable method for detecting HER2 gene status in breast cancer: a multicenter study using conventional scoring criteria and the new ASCO/CAP recommendations. Am J Clin Pathol. 2009; 131(4):490-7. DOI: 10.1309/AJCPI00TVGIGYXAA. View

16.

Bilous M, Morey A, Armes J, Cummings M, Francis G . Chromogenic in situ hybridisation testing for HER2 gene amplification in breast cancer produces highly reproducible results concordant with fluorescence in situ hybridisation and immunohistochemistry. Pathology. 2006; 38(2):120-4. DOI: 10.1080/00313020600561518. View

17.

Vera-Roman J, Rubio-Martinez L . Comparative assays for the HER-2/neu oncogene status in breast cancer. Arch Pathol Lab Med. 2004; 128(6):627-33. DOI: 10.5858/2004-128-627-CAFTNO. View

18.

Hynes N, Stern D . The biology of erbB-2/neu/HER-2 and its role in cancer. Biochim Biophys Acta. 1994; 1198(2-3):165-84. DOI: 10.1016/0304-419x(94)90012-4. View

19.

Gong Y, Sweet W, Duh Y, Greenfield L, Tarco E, Trivedi S . Performance of chromogenic in situ hybridization on testing HER2 Status in breast carcinomas with chromosome 17 polysomy and equivocal (2+) herceptest results: a study of two institutions using the conventional and new ASCO/CAP scoring criteria. Am J Clin Pathol. 2009; 132(2):228-36. DOI: 10.1309/AJCP4M2VUZCLDALN. View

20.

Lottner C, Schwarz S, Diermeier S, Hartmann A, Knuechel R, Hofstaedter F . Simultaneous detection of HER2/neu gene amplification and protein overexpression in paraffin-embedded breast cancer. J Pathol. 2005; 205(5):577-84. DOI: 10.1002/path.1742. View