Evaluation of clinical outcomes according to HER2 detection by fluorescence in situ hybridization in women with metastatic breast cancer treated with trastuzumab

Clinical Breast Cancer

Volumn 6, Issue 3, 2005, Pages 240-246

  Mass, Robert D ^a   Press, Michael F ^b   Anderson, Steven ^c   Cobleigh, Melody A ^d   Vogel, Charles L ^e   Dybdal, Noel ^a   Leiberman, Grazyna ^a   Slamon, Dennis J ^f   Paton, Virginia E ^a  

^a GENENTECH INC   (United States)

^b UNIVERSITY OF SOUTHERN CALIFORNIA   (United States)

^c LABORATORY CORPORATION OF AMERICA   (United States)

^d RUSH UNIVERSITY MEDICAL CENTER   (United States)

^e UNIVERSITY OF MIAMI MILLER SCHOOL OF MEDICINE   (United States)

^f UNIVERSITY OF CALIFORNIA   (United States)

Author keywords

Chemotherapy; Clinical benefit; Combined therapy; Response; Survival; Targeted therapy

Indexed keywords

ANTINEOPLASTIC AGENT; DOCETAXEL; EPIDERMAL GROWTH FACTOR RECEPTOR 2; TRASTUZUMAB; MONOCLONAL ANTIBODY;

ARTICLE; BREAST CANCER; CANCER CHEMOTHERAPY; CANCER SURVIVAL; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; DISEASE COURSE; FLUORESCENCE IN SITU HYBRIDIZATION; GENE AMPLIFICATION; HUMAN; IMMUNOHISTOCHEMISTRY; METASTASIS; MONOTHERAPY; PROTEIN EXPRESSION; RANDOMIZED CONTROLLED TRIAL; TREATMENT OUTCOME; TREATMENT RESPONSE; BREAST TUMOR; CANCER STAGING; FEMALE; GENETICS; PATHOLOGY; PATIENT SELECTION; PROTO ONCOGENE; REMISSION; RETROSPECTIVE STUDY; SURVIVAL;

ANTIBODIES, MONOCLONAL; ANTINEOPLASTIC AGENTS; BREAST NEOPLASMS; CLINICAL TRIALS; DISEASE PROGRESSION; FEMALE; GENES, ERBB-2; HUMANS; IN SITU HYBRIDIZATION, FLUORESCENCE; NEOPLASM METASTASIS; NEOPLASM STAGING; PATIENT SELECTION; REMISSION INDUCTION; RETROSPECTIVE STUDIES; SURVIVAL ANALYSIS; TREATMENT OUTCOME;

EID: 25144517586     PISSN: 15268209     EISSN: None     Source Type: Journal    
DOI: 10.3816/CBC.2005.n.026     Document Type: Article

References (41)

1. Slamon DJ, Godolphin W, Jones LA, et al. Studies of the HER-2/neu proto-oncogene in human breast and ovarian cancer. Science 1989; 44:707-712.
2. Kallioniemi OP, Kallioniemi A, Kurisu W, et al. ERBB2 amplification in breast cancer analyzed by fluorescence in situ hybridization. Proc Natl Acad Sci USA 1992; 89:5321-5325.
3. 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 1996; 13:63-72.
4. 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.
5. Gusterson BA, Gelber RD, Goldhirsch A, et al. Prognostic importance of c-erbB-2 expression in breast cancer. J Clin Oncol 1992; 7:1049-1056.
6. Andrulis IL, Bull SB, Blackstein ME, et al. neu/erbB-2 amplification identifies a poor-prognosis group of women with node-negative breast cancer. J Clin Oncol 1998; 16:1340-1349.
7. Press MF, Pike MC, Chazin VR, et al. 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 1993; 53:4960-4970.
8. Press MF, Bernstein L, Thomas PA, et al. HER-2/neu amplification characterized by fluorescence in situ hybridization: poor prognosis in node-negative breast carcinomas. J Clin Oncol 1997; 15:2894-2904.
9. Slamon DJ, Leyland-Jones B, Shak S, et al. Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. N Engl J Med 2001; 344:783-792.
10. Cobleigh MA, Vogel CL, Tripathy D, et al. 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 1999; 17:2639-2648.
11. Vogel CL, Cobleigh MA, Tripathy D, et al. Efficacy and safety of trastuzumab (Herceptin) as a single agent in first-line treatment of HER2-overexpressing metastatic breast cancer. J Clin Oncol 2002; 20:719-726.
12. Chazin VR, Kaleko M, Miller AD, et al. Transformation mediated by the human HER-2 gene independent of the epidermal growth factor receptor. Oncogene 1992; 7:1859-1866.
13. HER2 antibody for human cancer therapy. Proc Natl Acad Sci U S A 1992; 89:4285-4289.
14. 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 In Press.
15. Pauletti G, Dandekar S, Rong H, et al. 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 2000; 18:3651-3664.
16. Tubbs RR, Pettay JD, Roche PC, et al. Discrepancies in clinical laboratory testing of eligibility for trastuzumab therapy: apparent immunohistochemical false-positives do not get the message. J Clin Oncol 2001; 19:2714-2721.
17. Lebeau A, Deimling D, Kaltz C, et al. HER-2/neu analysis in archival tissue samples of human breast cancer: comparison of immunohistochemistry and fluorescence in situ hybridization. J Clin Oncol 2001; 19:354-363.
18. Jimenez RE, Wallis T, Tabasczka P, et al. Determination of HER-2/neu status in breast carcinoma: comparative analysis of immunohistochemistry and fluorescent in situ hybridization. Mod Pathol 2000; 13:37-45.
19. 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 Res1994; 54:2771-2777.
20. 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 1997; 10:720-727.
21. Ridolfi RL, Jamehdor MR, Arber JM. HER-2/neu testing in breast carcinoma: a combined immunohistochemistical and fluorescence in situ hybridization approach. Mod Pathol 2000; 13:866-873.
22. Seidman AD, Fornier MN, Esteva FJ, et al. Weekly trastuzumab and paclitaxel therapy for metastatic breast cancer with analysis of efficacy by HER2 immunophenotype and gene amplification. J Clin Oncol 2001; 19:2587-2595.
23. Thomson TA, Hayes MM, Spinelli JJ, et al. HER-2/neu in breast cancer: interobserver variability and performance of immunohistochemistry with 4 antibodies compared with fluorescent in situ hybridization. Mod Pathol 2001; 14:1079-1086.
24. Tsuda H, Akiyama F, Terasaki H, et al. Detection of HER-2/neu DNA amplification in primary breast carcinoma. Interobserver reproducibility and correlation with immunohistochemical HER-2 overexpression. Cancer 2001; 92:2965-2974.
25. Perez EA, Roche PC, Jenkins RB, et al. HER2 testing in patients with breast cancer: poor correlation between weak positivity by immunohistochemistry and gene amplification by fluorescence in situ hybridization. Mayo Clin Proc 2002; 77:148-154.
26. Hoang MP, Sahin AA, Ordonez NG, et al. HER-2/neu gene amplification compared with HER-2/neu protein overexpression and interobserver reproducibility in invasive breast cancer. Am J Clin Pathol 2000; 113:852-859.
27. Bartlett JMS, Going JJ, Mallon EA, et al. Evaluating HER2 amplification and overexpression in breast cancer. J Pathol 2001; 195:422-428.
28. Diaz NM. Laboratory testing for HER2/neu in breast carcinoma: an evolving strategy to predict response to targeted therapy. Cancer Control 2001; 8:415-418.
29. Kakar S, Puangsuvan N, Stevens JM, et al. HER-2/neu assessment in breast cancer by correlation with survival. Mol Diag 2000; 5:199-207.
30. 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 1999; 17:1974-1982.
31. Jacobs TW, Gown AM, Yaziji H, et al. Specificity of HercepTest in determining HER-2/neu status of breast cancers using the United States Food and Drug Administration-approved scoring system. J Clin Oncol 1999; 17:1983-1987.
32. Birner P, Oberhuber G, Stani J, 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 2001; 7:1669-1675.
33. Press MF, Slamon DJ, Flom KJ, et al. 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 2002; 20:3095-3105.
34. Kaplan EL, Meier P. Nonparametric estimation from incomplete observations. J Am Stat Assoc 1958; 53:457-481.
35. PathVysion™ HER-2 DNA Probe Kit [package instructions]. Downers Grove, IL: Vysis Inc; 2000.
36. Tedesco KL, Thor AD, Johnson DH, et al. Docetaxel combined with trastuzumab is an active regimen in HER-2 3+ overexpressing and fluorescent in situ hybridization-positive metastatic breast cancer: a multi-institutional phase II trial. J Clin Oncol 2004; 22:1071-1077.
37. Yaziji H, Gown AM. Testing for HER-2/neu in breast cancer: is fluorescence in situ hybridization superior in predicting outcome? Adv Anat Pathol 2002; 9:338-344.
38. Coussens L, Yang-Feng TL, Liao YC, et al. Tyrosine kinase receptor with extensive homology to EGF receptor shares chromosomal location with neu oncogene. Science 1985; 230:1132-1139.
39. Schechter AL, Stern DF, Vaidyanathan L, et al. The neu oncogene: an erb-B-related gene encoding a 185,000-Mr tumour antigen. Nature 1984; 312:513-516.
40. Varshney D, Zhou YY, Geller SA, et al. Determination of HER-2 status and chromosome 17 polysomy in breast carcinomas comparing HercepTest and PathVysion FISH assay. Am J Clin Pathol 2004; 121:70-77.
41. Andersson J, Linderholm B, Bergh J, et al. HER-2/neu (c-erbB-2) evaluation in primary breast carcinoma by fluorescent in situ hybridization and immunohistochemistry with special focus on intratumor heterogeneity and comparison of invasive and in situ components. Appl Immunohistochem Mol Morphol 2004; 12:14-20.