Specificity of HercepTest in determining HER-2/neu status of breast cancers using the United States Food and Drug Administration-approved scoring system

Journal of Clinical Oncology

Volumn 17, Issue 7, 1999, Pages 1983-1987

  Jacobs, Timothy W ^a   Gown, Allen M ^a   Yaziji, Hadi ^a   Barnes, Melissa J ^a   Schnitt, Stuart J ^a  

^a HARVARD MEDICAL SCHOOL   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ONCOPROTEIN; ONCOPROTEIN HER 2 NEU; UNCLASSIFIED DRUG;

ADULT; AGED; ARTICLE; BREAST CARCINOMA; CLINICAL ARTICLE; CONTROLLED STUDY; DEVICE; DIAGNOSTIC ACCURACY; DIAGNOSTIC VALUE; FEMALE; FOOD AND DRUG ADMINISTRATION; HUMAN; HUMAN TISSUE; IMMUNOHISTOCHEMISTRY; ONCOGENE NEU; PRIORITY JOURNAL; PROTEIN EXPRESSION; SCORING SYSTEM;

EID: 0033048939     PISSN: 0732183X     EISSN: None     Source Type: Journal    
DOI: 10.1200/jco.1999.17.7.1983     Document Type: Article

References (36)

1. 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 235:177-182, 1987
2. Clark GM: Prognostic and predictive factors, in Harris JR, Lippman ME, Morrow M, et al (eds): Diseases of the Breast. Philadelphia, PA, Lippincott-Raven, 1996, pp 461-85
3. Cobleigh MA, Vogel CL, Tripathy D, et al: Efficacy and safety of Herceptin (humanized anti-HER2 antibody) as a single agent in 222 women with HER2 overexpression who relapsed following chemotherapy for metastatic breast cancer. Proc Am Soc Clin Oncol 17:97A, 1998 (abstr 376)
4. Slamon D, Leyland-Jones B, Shak S, et al: Addition of Herceptin (humanized anti-HER2 antibody) to first line chemotherapy for HER2 overexpressing metastatic breast cancer (HER+/MBC) markedly increases anticancer activity: A randomized, multinational controlled phase III trial. Proc Am Soc Clin Oncol 17:98a, 1998 (abstr 377)
5. Pegram MD, Lipton A, Hayes DF, et al: Phase II study of receptor-enhanced chemosensitivity using recombinant humanized anti-p185HER2/neu monoclonal antibody plus cisplatin in patients with HER2/neu-overexpressing metastatic breast cancer refractory to chemotherapy treatment. J Clin Oncol 16:2659-2671, 1998
6. Allred DC, Clark GM, Tandon AK, et al: HER-2/neu in node-negative breast cancer: Prognostic significance of overexpression influenced by the presence of in situ carcinoma. J Clin Oncol 10:599-605, 1992
7. Gusterson BA, Gelber RD, Goldhirsch A, et al: Prognostic importance of c-erbB-2 expression in breast cancer. J Clin Oncol 10:1049-1056, 1992
8. Tetu B, Brisson J: Prognostic significance of HER-2/neu oncoprotein expression in node-positive breast cancer. The influence of the pattern of immunostaining and adjuvant therapy. Cancer 73:2359-2365, 1994
9. Stal O, Sullivan S, Wingren S, et al: c-erbB-2 expression and benefit from adjuvant chemotherapy and radiotherapy of breast cancer. Eur J Cancer 31A:2185-2190, 1995
10. Bitran JD, Samuels B, Trujillo Y, et al: Her2/neu overexpression is associated with treatment failure in women with high-risk stage II and stage IIIA breast cancer (>10 involved lymph nodes) treated with high-dose chemotherapy and autologous hematopoietic progenitor cell support following standard-dose adjuvant chemotherapy. Clin Cancer Res 2:1509-1513, 1996
11. Tetu B, Brisson J, Plante V, et al: p53 and c-erbB-2 as markers of resistance to adjuvant chemotherapy in breast cancer. Mod Pathol 11:823-830, 1998
12. Muss HB, Thor AD, Berry DA, et al: c-erbB-2 expression and response to adjuvant therapy in women with node-positive early breast cancer. N Engl J Med 330:1260-1266, 1994
13. Thor AD, Berry DA, Budman DR, et al: erbB-2, p53, and efficacy of adjuvant therapy in lymph node-positive breast cancer [see comments]. J Natl Cancer Inst 90:1346-1360, 1998
14. 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 [see comments]. J Natl Cancer Inst 90:1361-1370, 1998
15. Ravdin PM, Green S, Albain KS, et al: Initial report of the SWOG biological correlative study of c-erbB-2 expression as a predictor of outcome in a trial comparing adjuvant CAF T with Tamoxifen (T) alone. Proc Am Soc Clin Oncol 17:97A, 1998 (abstr 374)
16. Wright C, Nicholson S, Angus B, et al: Relationship between c-erbB-2 protein product expression and response to endocrine therapy in advanced breast cancer. Br J Cancer 65:118-121, 1992
17. Borg A, Baldetorp B, Ferno M, et al: ERBB2 amplification is associated with tamoxifen resistance in steroid-receptor positive breast cancer. Cancer Lett 81:137-144, 1994
18. Carlomagno C, Perrone F, Gallo C, et al: c-erb B2 overexpression decreases the benefit of adjuvant tamoxifen in early-stage breast cancer without axillary lymph node metastases. J Clin Oncol 14:2702-2708, 1996
19. Sjogren S, Inganas M, Lindgren A, et al: Prognostic and predictive value of c-erbB-2 overexpression in primary breast cancer, alone and in combination with other prognostic markers. J Clin Oncol 16:462-469, 1998
20. Singleton TP, Niehans GA, Gu F, et al: Detection of c-erbB-2 activation in paraffin-embedded tissue by immunohistochemistry. Hum Pathol 23:1141-1150, 1992
21. Kerns BJ, Jordan PA, Huper G, et al: Assessment of c-erbB-2 amplification by immunohistochemistry in paraffin-embedded breast cancer. Mod Pathol 6:673-678, 1993
22. Bobrow LG, Happerfield LC, Millis RR: Comparison of immunohistological staining with different antibodies to the c-erbB-2 oncoprotein. Appl Immunohistochem 4:128-134, 1996
23. Press MF, Hung G, Godolphin W, et al: Sensitivity of HER-2/neu antibodies in archival tissue samples: Potential source of error in immunohistochemical studies of oncogene expression. Cancer Res 54:2771-2777, 1994
24. Kay EW, Walsh CJ, Cassidy M, et al: C-erbB-2 immunostaining: problems with interpretation. J Clin Pathol 47:816-822, 1994
25. Busmanis I, Feleppa F, Jones A, et al: Analysis of cerbB2 expression using a panel of 6 commercially available antibodies. Pathology 26:261-267, 1994
26. Ross JS, Fletcher JA: The HER-2/neu oncoprotein in breast cancer: Prognostic factor, predictive factor, and target for therapy. Oncologist 3:237-252, 1998
27. Clark GM: Should selection of adjuvant chemotherapy for patients with breast cancer be based on erbB-2 status? J Natl Cancer Inst 90:1320-1321, 1998 (editorial)
28. Graziano C: HER-2 breast assay, linked to Herceptin, wins FDA's okay. CAP Today 12:13-16, 1998
29. Jacobs TW, Gown AM, Yaziji H, et al: Comparison of fluorescence in situ hybridization and immunohistochemistry for the evaluation of HER-2/neu in breast cancer. J Clin Oncol 17:1974-1982, 1999
30. Jacobs TW, Barnes M, Yaziji H, et al: HER2/neu protein expression in breast cancer determined by immunohistochemistry (IHC): A study of inter-laboratory agreement. Mod Pathol 12:23A, 1999 (abstr)
31. Oncor: Oncor INFORM HER-2/neu Gene Detection System. Procedure and Interpretation Guide. Gaithersburg, MD, Oncor, Inc, 1998
32. Elston CW, Ellis IO: Pathological prognostic factors in breast cancer: I. The value of histological grade in breast cancer - Experience from a large study with long-term follow-up. Histopathology 19:403-410, 1991
33. Kallioniemi OP, Kallioniemi A, Kurisu W, et al: ERBB2 amplification in breast cancer analyzed by fluorescence in situ hybridization. Proc Natl Acad Sci U S A 89:5321-5325, 1992
34. Pauletti G, Godolphin W, Press MF, et al: Detection and quantitation of HER-2/neu gene amplification in human breast cancer archival material using fluorescence in situ hybridization. Oncogene 13:63-72, 1996
35. Persons DL, Borelli KA, Hsu PH: Quantitation of HER-2/neu and c-myc gene amplification in breast carcinoma using fluorescence in situ hybridization. Mod Pathol 10:720-727, 1997
36. Roche PC, Ingle JN: Increased HER2 with U.S. Food and Drug Administration-approved antibody. J Clin Oncol 17:434, 1999 (letter)