What causes discrepancies in HER2 testing for breast cancer? A Japanese ring study in conjunction with the global standard

American Journal of Clinical Pathology

Volumn 130, Issue 6, 2008, Pages 883-891

  Umemura, Shinobu ^a   Osamura, R Yoshiyuki ^a   Akiyama, Futoshi ^b   Honma, Keiichi ^c   Kurosumi, Masafumi ^d   Sasano, Hironobu ^e   Toyoshima, Satoshi ^f   Tsuda, Hitoshi ^g   Rüschoff, Josef ^h   Sakamoto, Goi ⁱ  

^a TOKAI UNIVERSITY SCHOOL OF MEDICINE   (Japan)

^b CANCER CHEMOTHERAPY CENTER   (Japan)

^c NIIGATA CANCER CENTER HOSPITAL   (Japan)

^d SAITAMA CANCER CENTER   (Japan)

^e TOHOKU UNIVERSITY SCHOOL OF MEDICINE   (Japan)

^f KITAKYUSHU MUNICIPAL MEDICAL CENTER   (Japan)

^g NATIONAL DEFENSE MEDICAL COLLEGE   (Japan)

^h Institute of Pathology Nordhessen   (Germany)

ⁱ Department of Pathology   (Japan)

Author keywords

Assessment; Breast cancer; Fluorescence in situ hybridization; HER2 testing; Immunohistochemistry; Multicenter study; Ring study

Indexed keywords

EPIDERMAL GROWTH FACTOR RECEPTOR 2; TRASTUZUMAB;

ARTICLE; BREAST CANCER; CANCER CHEMOTHERAPY; CLINICAL ARTICLE; CLINICAL EVALUATION; CONTROLLED STUDY; FLUORESCENCE IN SITU HYBRIDIZATION; HUMAN; HUMAN TISSUE; IMMUNOHISTOCHEMISTRY; PRIORITY JOURNAL; SCORING SYSTEM;

ANTIBODIES, MONOCLONAL; BREAST NEOPLASMS; FEMALE; GENES, ERBB-2; HUMANS; IMMUNOHISTOCHEMISTRY; IN SITU HYBRIDIZATION, FLUORESCENCE; JAPAN; OBSERVER VARIATION; PRACTICE GUIDELINES AS TOPIC; RECEPTOR, ERBB-2; REPRODUCIBILITY OF RESULTS;

EID: 58049212011     PISSN: 00029173     EISSN: None     Source Type: Journal    
DOI: 10.1309/AJCP5UUMFMA5ZKII     Document Type: Article

References (22)

1. Akiyama T, Sudo C, Ogawara H, et al. The product of the human c-erbB-2 gene: a 185-kilodalton glycoprotein with tyrosine kinase activity. Science. 1986;232:1644-1646.
2. Slamon DJ, Clark GM, Wong SG, et al. Human breast cancer: correlation of relapse and survival with amplification of the HER-2/neu oncogene. Science. 1987;235:177-182.
3. Press MF, Bernstein L, Thomas PA, et al. HER-2/neu gene amplification characterized by fluorescence in situ hybridization: poor prognosis in node-negative breast carcinomas. J Clin Oncol. 1997;15:2894-2904.
4. Seshadri R, Firgaira FA, Horsfall DJ, et al. Clinical significance of HER-2/neu oncogene amplification in primary breast cancer. The South Australian Breast Cancer Study Group. J Clin Oncol. 1993;11:1936-1942.
5. Leitzel K, Teramoto Y, Konrad K, et al. Elevated serum c-erbB-2 antigen levels and decreased response to hormone therapy of breast cancer. J Clin Oncol. 1995;13:1129-1135.
6. Yamauchi H, O'Neill A, Gelman R, et al. Prediction of response to antiestrogen therapy in advanced breast cancer patients by pretreatment circulating levels of extracellular domain of the HER-2/c-neu protein. J Clin Oncol. 1997;15:2518-2525.
7. Paik S, Bryant J, Park C, et al. erbB-2 and response to doxorubicin in patients with axillary lymph node-positive, hormone receptor-negative breast cancer. J Natl Cancer Inst. 1998;90:1361-1370.
8. Thor AD, Berry DA, Budman DR, et al. erbB-2, p53, and efficacy of adjuvant therapy in lymph node-positive breast cancer. J Natl Cancer Inst. 1998;90:1346-1360.
9. Konecny GE, Thomssen C, Luck HJ, et al. HER-2/neu gene amplification and response to paclitaxel in patients with metastatic breast cancer. J Natl Cancer Inst. 2004;96:1141-1151.
10. Goldhirsch A, Coates AS, Gelber RD, et al. First: select the target: better choice of adjuvant treatments for breast cancer patients. Ann Oncol. 2006;17:1772-1776.
11. Ellis MJ, Coop A, Singh B, et al. Letrozole is more effective neoadjuvant endocrine therapy than tamoxifen for erbB-1-and/or erbB-2-positive, estrogen receptor-positive primary breast cancer: evidence from a phase III randomized trial. J Clin Oncol. 2001;19:3808-3816.
12. Slamon D, Eiermann W, Robert N, et al. Phase III randomized trial comparing doxorubicin and cyclophosphamide followed by docetaxel (ACT) with doxorubicin and cyclophosphamide followed by docetaxel and trastuzumab (ACTH) with docetaxel, carboplatin and trastuzumab (TCH) in HER2 positive early breast cancer patients: BCIRG 006 study [abstract]. Breast Cancer Res Treat. 2005;94(suppl 1):S5. Abstract 1.
13. Joensuu H, Kellokumpu-Lehtinen PL, Bono P, et al. Adjuvant docetaxel or vinorelbine with or without trastuzumab for breast cancer. N Engl J Med. 2006;354:809-820.
14. Romond EH, Perez EA, Bryant J, et al. Trastuzumab plus adjuvant chemotherapy for operable HER2-positive breast cancer. N Engl J Med. 2005;353:1673-1684.
15. Smith I, Procter M, Gelber RD, et al. 2-year follow-up of trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer: a randomised controlled trial. Lancet. 2007;369:29-36.
16. Dybdal N, Leiberman G, Anderson S, et al. Determination of HER2 gene amplification by fluorescence in situ hybridization and concordance with the clinical trials immunohistochemical assay in women with metastatic breast cancer evaluated for treatment with trastuzumab. Breast Cancer Res Treat. 2005;93:3-11.
17. Vogel CL, Cobleigh MA, Tripathy D, et al. Efficacy and safety of trastuzumab as a single agent in first-line treatment of HER2-overexpressing metastatic breast cancer. J Clin Oncol. 2002;20:719-726.
18. Dowsett M, Bartlett J, Ellis IO, et al. Correlation between immunohistochemistry (HercepTest) and fluorescence in situ hybridization (FISH) for HER-2 in 426 breast carcinomas from 37 centers. J Pathol. 2003;199:418-423.
19. Yaziji H, Goldstein LC, Barry TS, et al. HER-2 testing in breast cancer using parallel tissue-based methods. JAMA. 2004;291:1972-1977.
20. Dowsett M, Hanna WM, Kockx M, et al. Standardisation of HER2 testing: results of an international proficiency-testing ring study. Mod Pathol. 2007:20:584-591.
21. Wolff AC, Hammond ME, Schwartz JN, et al. 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. 2007;131:19-26.
22. Umemura S, Sakamoto G, Sasano H, et al. Evaluation of HER2 status: for the treatment of metastatic breast cancers by humanized anti-HER2 monoclonal antibody (trastuzumab). Pathological Committee for Optimal Use of Trastuzumab. Breast Cancer. 2001;8:316-320.