Journal of Clinical Oncology, Vol 17, Issue 7
(July), 1999: 1983
© 1999 American Society for Clinical Oncology
Specificity of HercepTest in Determining HER-2/neu Status of Breast Cancers Using the United States Food and Drug AdministrationApproved Scoring System
Timothy W. Jacobs,
Allen M. Gown,
Hadi Yaziji,
Melissa J. Barnes,
Stuart J. Schnitt
From the Department of Pathology, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, MA; and PhenoPath Laboratories and IRIS, Seattle, WA.
Address reprint requests to Stuart J. Schnitt, MD, Department of Pathology, Beth Israel Deaconess Medical CenterEast Campus, 330 Brookline Ave, Boston, MA 02215; email sschnitt{at}caregroup harvard.edu.
ABSTRACT
PURPOSE: To evaluate the specificity of the HercepTest for Immunoenzymatic Staining (Dako Corp, Carpinteria, CA) for determining HER-2/neu protein expression in breast cancer.
MATERIALS AND METHODS: Forty-eight invasive breast cancers previously found to be HER-2/neunegative by two different immunohistochemical (IHC) assays and not amplified for the HER-2/neu gene by fluorescence in situ hybridization were studied using the HercepTest kit. HercepTest was performed according to the manufacturer's guidelines, and the results were scored on a 0 to 3+ scale using the United States Food and Drug Administration (FDA)approved grading system. In this system, cases scored as 2+ or 3+ are considered HER-2/neupositive.
RESULTS: Among these 48 cases, the IHC score using the FDA-approved scoring system was 0 in four cases (8.3%), 1+ in 16 (33.3%), 2+ in 21 (43.8%), and 3+ in seven (14.6%). Therefore, 58.4% of these cases were categorized as HER-2/neupositive, and the specificity of the HercepTest kit for HER-2/neu expression was 41.6%. However, with the use of a modified scoring system that took into account the level of staining of nonneoplastic epithelium, the specificity increased to 93.2%.
CONCLUSION: Our results indicate that the HercepTest kit, when used in accordance with the manufacturer's guidelines and the FDA-approved scoring system, results in a large proportion of breast cancers being categorized as positive for HER-2/neu protein expression and that many of these seem to be false-positives. Consideration of the level of staining of nonneoplastic epithelium resulted in improved specificity. The current FDA-approved scoring system for HercepTest results should be reevaluated before its widespread use in clinical practice.

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Evaluation of HER-2/neu Gene Amplification and Overexpression: Comparison of Frequently Used Assay Methods in a Molecularly Characterized Cohort of Breast Cancer Specimens
J. Clin. Oncol.,
July 15, 2002;
20(14):
3095 - 3105.
[Abstract]
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W. K. Funkhouser and K. Kaiser-Rogers
Significance of, and Optimal Screening for, HER-2 Gene Amplification and Protein Overexpression in Breast Carcinoma
Ann. Clin. Lab. Sci.,
October 1, 2001;
31(4):
349 - 358.
[Abstract]
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K. I. Pritchard
Use of ErbB-1 and ErbB-2 to Select Endocrine Therapy for Breast Cancer: Will It Play in Peoria?
J. Clin. Oncol.,
September 15, 2001;
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3795 - 3797.
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M. J. Ellis, A. Coop, B. Singh, L. Mauriac, A. Llombert-Cussac, F. Janicke, W. R. Miller, D. B. Evans, M. Dugan, C. Brady, 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.,
September 15, 2001;
19(18):
3808 - 3816.
[Abstract]
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I. Osman, H. I. Scher, M. Drobnjak, D. Verbel, M. Morris, D. Agus, J. S. Ross, and C. Cordon-Cardo
HER-2/neu (p185neu) Protein Expression in the Natural or Treated History of Prostate Cancer
Clin. Cancer Res.,
September 1, 2001;
7(9):
2643 - 2647.
[Abstract]
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J. Brabender, K. D. Danenberg, R. Metzger, P. M. Schneider, J. Park, D. Salonga, A. H. Holscher, and P. V. Danenberg
Epidermal Growth Factor Receptor and HER2-neu mRNA Expression in Non-Small Cell Lung Cancer Is Correlated with Survival
Clin. Cancer Res.,
July 1, 2001;
7(7):
1850 - 1855.
[Abstract]
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P. Birner, G. Oberhuber, J. Stani, C. Reithofer, H. Samonigg, H. Hausmaninger, E. Kubista, W. Kwasny, D. Kandioler-Eckersberger, M. Gnant, et al.
Evaluation of the United States Food and Drug Administration-approved Scoring and Test System of HER-2 Protein Expression in Breast Cancer
Clin. Cancer Res.,
June 1, 2001;
7(6):
1669 - 1675.
[Abstract]
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A. D. Seidman, M. N. Fornier, F. J. Esteva, L. Tan, S. Kaptain, A. Bach, K. S. Panageas, C. Arroyo, V. Valero, V. Currie, et al.
Weekly Trastuzumab and Paclitaxel Therapy for Metastatic Breast Cancer With Analysis of Efficacy by HER2 Immunophenotype and Gene Amplification
J. Clin. Oncol.,
May 15, 2001;
19(10):
2587 - 2595.
[Abstract]
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R.R. Tubbs, J.D. Pettay, P.C. Roche, M.H. Stoler, R.B. Jenkins, and T.M. Grogan
Discrepancies in Clinical Laboratory Testing of Eligibility for Trastuzumab Therapy: Apparent Immunohistochemical False-Positives Do Not Get the Message
J. Clin. Oncol.,
May 15, 2001;
19(10):
2714 - 2721.
[Abstract]
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H. J. Burstein, I. Kuter, S. M. Campos, R. S. Gelman, L. Tribou, L. M. Parker, J. Manola, J. Younger, U. Matulonis, C. A. Bunnell, et al.
Clinical Activity of Trastuzumab and Vinorelbine in Women With HER2-Overexpressing Metastatic Breast Cancer
J. Clin. Oncol.,
May 15, 2001;
19(10):
2722 - 2730.
[Abstract]
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H. Yamauchi, V. Stearns, and D. F. Hayes
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.,
April 15, 2001;
19(8):
2334 - 2356.
[Abstract]
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L. N. Harris, V. Liotcheva, G. Broadwater, M. J. Ramirez, P. Maimonis, S. Anderson, T. Everett, D. Harpole, M. B. Moore, D. A. Berry, et al.
Comparison of Methods of Measuring HER-2 in Metastatic Breast Cancer Patients Treated With High-Dose Chemotherapy
J. Clin. Oncol.,
March 15, 2001;
19(6):
1698 - 1706.
[Abstract]
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A. Lebeau, D. Deimling, C. Kaltz, A. Sendelhofert, A. Iff, B. Luthardt, M. Untch, and U. Lohrs
HER-2/neu Analysis in Archival Tissue Samples of Human Breast Cancer: Comparison of Immunohistochemistry and Fluorescence In Situ Hybridization
J. Clin. Oncol.,
January 15, 2001;
19(2):
354 - 363.
[Abstract]
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S. Signoretti, R. Montironi, J. Manola, A. Altimari, C. Tam, G. Bubley, S. Balk, G. Thomas, I. Kaplan, L. Hlatky, et al.
Her-2-neu Expression and Progression Toward Androgen Independence in Human Prostate Cancer
J Natl Cancer Inst,
December 6, 2000;
92(23):
1918 - 1925.
[Abstract]
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G. Pauletti, S. Dandekar, H. Rong, L. Ramos, H. Peng, R. Seshadri, and D. J. Slamon
Assessment of Methods for Tissue-Based Detection of the HER-2/neu Alteration in Human Breast Cancer: A Direct Comparison of Fluorescence In Situ Hybridization and Immunohistochemistry
J. Clin. Oncol.,
November 1, 2000;
18(21):
3651 - 3664.
[Abstract]
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M. Tanner, D. Gancberg, A. Di Leo, D. Larsimont, G. Rouas, M. J. Piccart, and J. Isola
Chromogenic in Situ Hybridization : A Practical Alternative for Fluorescence in Situ Hybridization to Detect HER-2/neu Oncogene Amplification in Archival Breast Cancer Samples
Am. J. Pathol.,
November 1, 2000;
157(5):
1467 - 1472.
[Abstract]
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R. R. Tubbs, J. Pettay, P. Roche, M. H. Stoler, R. Jenkins, J. Myles, and T. Grogan
Concomitant Oncoprotein Detection with Fluorescence in Situ Hybridization (CODFISH): A Fluorescence-Based Assay Enabling Simultaneous Visualization of Gene Amplification and Encoded Protein Expression
J. Mol. Diagn.,
May 1, 2000;
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78 - 83.
[Abstract]
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S Wang, M H Saboorian, E Frenkel, L Hynan, S T Gokaslan, and R Ashfaq
Laboratory assessment of the status of Her-2/neu protein and oncogene in breast cancer specimens: comparison of immunohistochemistry assay with fluorescence in situ hybridisation assays
J. Clin. Pathol.,
May 1, 2000;
53(5):
374 - 381.
[Abstract]
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S. Seelig, T. W. Jacobs, S. J. Schnitt, A. M. Gown, and H. Yaziji
Fluorescence In Situ Hybridization Versus Immunohistochemistry: Importance of Clinical Outcome
J. Clin. Oncol.,
November 1, 1999;
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3690 - 3692.
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