Targeted therapy for cancer: The HER-2/neu and Herceptin™ story

Clinical Leadership and Management Review

Volumn 17, Issue 6, 2003, Pages 333-340

  Ross, Jeffrey S ^a,b   Gray, Gary S ^b  

^a ALBANY MEDICAL COLLEGE   (United States)

^b MILLENNIUM PHARMACEUTICALS INC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTINEOPLASTIC AGENT; EPIDERMAL GROWTH FACTOR RECEPTOR 2; MONOCLONAL ANTIBODY; TRASTUZUMAB; TUMOR MARKER;

BREAST TUMOR; DRUG DELIVERY SYSTEM; FEMALE; GENE EXPRESSION REGULATION; GENETICS; HUMAN; IMMUNOHISTOCHEMISTRY; MULTIMODALITY CANCER THERAPY; PROTO ONCOGENE; REVIEW;

ANTIBODIES, MONOCLONAL; ANTINEOPLASTIC AGENTS; BREAST NEOPLASMS; COMBINED MODALITY THERAPY; DRUG DELIVERY SYSTEMS; FEMALE; GENE EXPRESSION REGULATION, NEOPLASTIC; GENES, ERBB-2; HUMANS; IMMUNOHISTOCHEMISTRY; RECEPTOR, ERBB-2; TUMOR MARKERS, BIOLOGICAL;

EID: 1542647611     PISSN: 15273954     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (70)

1. Osborne CK. Steroid hormone receptors in breast cancer management. Breast Cancer Res Treat, 1998;51:227-238.
2. Early Breast Cancer Trialists' Collaborative Group. Polychemotherapy for early breast cancer: an overview of the randomized trials. Lancet, 1998;352:930-942.
3. Guy CT, Webster MA, Schaller M, et al. Expression of the neu protooncogene in the mammary epithelium of transgenic mice induces metastatic disease. Proc Natl Acad Sci USA, 1992;89:10578-10582.
4. Drebin JA, Link VC, Stern DF, et al. Down-modulation of an oncogene protein product and reversion of the transformed phenotype by monoclonal antibodies. Cell, 1985;41:697-706.
5. Ross JS, Fletcher JA. The Her-2/neu oncogene: prognostic factor, predictive factor and target for therapy [invited submission]. Stem Cells, 1998;16(6):413-428.
6. 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.
7. Ravdin PM, Chamness GC. The c-erbB-2 proto-oncogene as a prognostic and predictive marker in breast cancer: a paradigm for the development of other macromolecular markers - a review. Gene, 1995;159:19-27.
8. Dowsett M, Bartlett J, Ellis IO, et al. Correlation between immunohistochemistry (Hercep Test) and fluorescence in situ hybridization (FISH) for HER-2 in 426 breast carcinomas from 37 centres. J Pathol. 2003;199:411-417.
9. Hayes DF, Thor AD. c-erbB-2 in breast cancer: development of a clinically useful market. Semin Oncol, 2002;29:231-245.
10. Masood S, Bui MM. Prognostic and predictive value of HER2/neu oncogene in breast cancer. Microsc Res Tech, 2002;59:102-108.
11. Paik S, Bryant J, Tan-Chiu E, et al. Real-world performance of HER2 testing: National Surgical Adjuvant Breast and Bowel Project experience. J Natl Cancer Inst, 2002;94:852-854.
12. Wang S, Saboorian MH, Frenkel FP, et al. Assessment of HER-2/neu status in breast cancer. Automated Cellular Imaging System (ACIS)-assisted quantitation of immunohistochemical assay achieves high accuracy in comparison with fluorescence in situ hybridization assay as the standard. Am J Clin Pathol, 2001;116:495-503.
13. Wang S, Saboorian MH, Frenkel F, et al. Laboratory assessment of the status of Her-2/neu protein and oncogene in breast cancer specimens: comparison of immunohistochemistry assay with flourescence in situ hybridisation assays. J Clin Pathol. 2000;53:374-381.
14. Tanner M, Gancberg D, Di Leo A, et al. 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, 2000;157:1467-1472.
15. Zhao J, Wu R, Au A, et al. Determination of HER2 gene amplification by chromogenic in situ hybridization (CISH) in archival breast carcinoma. Mod Pathol. 2002;15:657-665.
16. Pawlowski V, Revillion F, Hornez F, et al. A real-time one step reverse transcriptase-polymerase chain reaction method to quantify c-erbB-2 expression in human breast cancer. Cancer Detect Prev, 2000;24:212-223.
17. Bieche I, Onody P, Laurendeau I, et al. Real-time reverse transcription-PCR assay for future management of ERBB2-based clinical applications. Clin Chem, 1999;45:1148-1156.
18. 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;19:2714-21
19. Pawlowski V, Revillion F, Hebbar M, et al. Prognostic value of the type I growth factor receptors in a large series of human primary breast cancers quantified with a real-time reverse transcription-polymerase chain reaction assay. Clin Cancer Res. 2000;6:4217-4225.
20. Huston JS, George AJ. Engineered antibodies take center stage. Hum Antibodies, 2001;10:127-142.
21. Hortobagyi GN. Overview of treatment results with trastuzumab (Herceptin) in metastatic breast cancer. Semin Oncol, 2001;28:43-47.
22. McKeage K, Perry CM. Trastuzumab: a review of its use in the treatment of metastatic breast cancer overexpressing HER2. Drugs, 2002;62:209-243.
23. Shawver LK, Slamon D, Ullrich A. Smart drugs: tyrosine kinase inhibitors in cancer therapy. Cancer Cell, 2002;1:117-123.
24. Ligibel JA, Winer FP. Trastuzumab/chemotherapy combinations in metastatic breast cancer. Semin Oncol, 2002;29:38-43.
25. 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.
26. Roche PC, Ingle JN. Increased HER2 with U.S. Food and Drug Administration-approved antibody. J Clin Oncol, 1999;17(1):434.
27. Mass RD, Press MF, Anderson S, et al. Improved survival benefit from Herceptin (trastuzumab) in patients selected by fluorescence in situ hybridization (FISH). Proc Am Soc Clin Oncol, 2001;85.
28. Nichols DW, Wolff DJ, Self S, et al. A testing algorithm for determination of HER2 status in patients with breast cancer. Ann Clin Lab Sci, 2002;32:3-11.
29. Kobayashi M, Ooi A, Oda Y, et al. Protein overexpression and gene amplification of c-erbB-2 in breast carcinomas: a comparative study of immunohistochemistry and fluorescence in situ hybridization of formalin-fixed, paraffin-embedded tissues. Hum Pathol, 2002;33:21-28.
30. 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.
31. Schnitt SJ, Jacobs TW. Current status of HER2 testing: caught between a rock and a hard place. Am J Clin Pathol, 2001;116:806-810.
32. 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.
33. Lipton A, Ali SM, Leitzel K, et al. Elevated serum Her-2/neu level predicts decreased response to hormone therapy in metastatic breast cancer. J Clin Oncol, 2002;20:1467-1472.
34. Volas GH, Leitzel K, Teramoto Y, et al. Serial serum C-erbB-2 levels in patients with breast carcinoma. Cancer, 1996;78:267-272.
35. Bose S, Lesser ML, Norton L, et al. Immunophenotype of intraductal carcinoma. Arch Pathol Lab Med, 1996;120:81-85.
36. Moreno A, Lloveras B, Figueras A, et al. Ductal carcinoma in situ of the breast: correlation between histologic classification and biologic markers. Mod Pathol, 1997;10:1088-1092.
37. Mark L, Kerkzelit N, Doig G, et al. Relationship of a new histological categorization of ductal carcinoma in-situ of the breast with size and the immunohistochemical expression of p53, C-erb B2, bcl2 and ki-67. Hum Pathol, 1997;28:974-979.
38. Wolber RA, DuPuis BA, Wick MR. Expression of cerb B2 oncoprotein in mammary and extramammary Paget's disease. Am J Clin Pathol, 1991;96:243-247.
39. Fu W, Lobocki CA, Silberberg BK, et al. Molecular markers in Paget disease of the breast. J Surg Oncol, 2001;77:171-178.
40. Masood S, Bui MM. Assessment of Her-2/neu overexpression in primary breast cancers and their metastatic lesions: an immunohistochemical study. Ann Clin Lab Sci, 2000;30:259-265.
41. Dittadi R, Zancan M, Perasole A, et al. Evaluation of HER-2/neu in serum and tissue of primary and metastatic breast cancer patients using an automated enzyme immunoassay. Int J Biol Markers, 2001;16:255-261.
42. Simon R, Nocito A, Hubscher T, et al. Patterns of her-2/neu amplification and overexpression in primary and metastatic breast cancer. J Natl Cancer Inst, 2001;93:1141-1146.
43. Vincent-Salomon A, Jouve M, Genin P, et al. HER2 status in patients with breast carcinoma is not modified selectively by preoperative chemotherapy and is stable during the metastatic process. Cancer, 2002;94:2169-2173.
44. Xu R, Perle MA, Inghirami G, et al. Amplification of Her-2/neu gene in Her-2/neu-overexpressing and -nonexpressing breast carcinomas and their synchronous benign, premalignant, and metastatic lesions detected by FISH in archival material. Mod Pathol, 2002;15:116-124.
45. Joshi MG, Lee AK, Loda M, et al. Male breast carcinoma: an evaluation of prognostic factors contributing to a poorer outcome. Cancer, 1996;77:490-498.
46. Pich A, Margaria E, Chiusa L. Oncogenes and male breast carcinoma: c-erbB-2 and p53 coexpression predicts a poor survival. J Clin Oncol, 2000;18:2948-2956.
47. Wang-Rodriguez J, Cross K, Gallagher S, et al. Male breast carcinoma: correlation of ER, PR, Ki-67, Her2-Neu, and p53 with treatment and survival, a study of 65 cases. Mod Pathol, 2002;15:853-861.
48. Rayson D, Erlichman C, Suman VJ, et al. Molecular markers in male breast carcinoma. Cancer, 1998;83:1947-1955.
49. Shpitz B, Bornstein Y, Sternberg A, et al. Angiogenesis, p53, and c-erbB-2 immunoreactivity and clinicopathological features in male breast cancer. J Surg Oncol, 2000;75:252-257.
50. Bloom KJ, Govil H, Gattuso P, et al. Status of HER-2 in male and female breast carcinoma. Am J Surg, 2001;182:389-392.
51. Stark A, Hulka BS, Joens S, et al. HER-2/neu amplification in benign breast disease and the risk of subsequent breast cancer. J Clin Oncol, 2000;18:267-274.
52. Piccart M, Lohrisch C, Di Leo A, et al. The predictive value of HER2 in breast cancer. Oncology, 2001;61(suppl 2):73-82.
53. Dowsett M. Overexpression of HER-2 as a resistance mechanism to hormonal therapy for breast cancer. Endocr Relat Cancer, 2001;8:191-195.
54. Muss HB. Role of adjuvant endocrine therapy in early-stage breast cancer. Semin Oncol, 2001;28:313-321.
55. Schmid P, Wischnewsky MB, Sezer O, et al. Prediction of response to hormonal treatment in metastatic breast cancer. Oncology, 2002;63:309-316.
56. Nunes RA, Harris LN. The HER2 extracellular domain as a prognostic and predictive factor in breast cancer. Clin Breast Cancer, 2002;3:125-135.
57. 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.
58. Berns EM, Foekens JA, vanStaveren IL et al. Oncogene amplification and prognosis in breast cancer: relationship with systemic treatment. Gene, 1995;159:11-18.
59. Sparano JA. Taxanes for breast cancer: an evidence-based review of randomized phase II and phase III trials. Clin Breast Cancer, 2000;1:32-40.
60. Yu D. Mechanisms of ErbB2-mediated paclitaxel resistance and trastuzumab-mediated paclitaxel sensitization in ErbB2-overexpressing breast cancers. Semin Oncol, 2001;28(suppl 16):12-17.
61. Kim R, Tanabe K, Uchida Y, et al. The role of HER-2 oncoprotein in drug-sensitivity in breast cancer. Oncol Rep, 2002;9:3-9.
62. Hamilton A, Larsimont D, Paridaens R, et al. A study of the value of p53, HER2, and Bcl-2 in the prediction of response to doxorubicin and paclitaxel as single agents in metastatic breast cancer: a companion study to EORTC 10923. Clin Breast Cancer, 2000;1:233-240.
63. Di Leo A, Larsimont D, Gancberg D, et al. HER-2 and topo-isomerase IIalpha as predictive markers in a population of node-positive breast cancer patients randomly treated with adjuvant CMF or epirubicin plus cyclophosphamide. Ann Oncol, 2001;12:1081-1089.
64. Petit T, Borel C, Ghnassia JP, et al. Chemotherapy response of breast cancer depends on HER-2 status and anthracycline dose intensity in the neoadjuvant setting. Clin Cancer Res, 2001;7:1577-1581.
65. Harris LN, Yang L, Liotcheva V, et al. Induction of topoisomerase II activity after ErbB2 activation is associated with a differential response to breast cancer chemotherapy. Clin Cancer Res, 2001;7:1497-1504.
66. Weinstein JN. Pharmacogenomics: teaching old drugs new tricks. N Engl J Med, 2000;343:1408-1409.
67. Slonim DK. Transcriptional profiling in cancer: the path to clinical pharmacogenomics. Pharmacogenomics, 2001;2:123-136.
68. Ayers M, Symmans WF, Stec J, et al. Gene expression profiling of fine needle aspirations of breast cancer identifies genes associated with complete pathologic response to neoadjuvant taxol/FAC chemotherapy [Abstract 220]. Breast Cancer Res Treat, 2002;76(suppl):64.
69. Amos J, Patnaik M. Commercial molecular diagnostics in the U.S.: the Human Genome Project to the clinical laboratory. Hum Mutat, 2002;19:324-333.
70. Bottles K. A revolution in genetics: changing medicine, changing lives. Physician Exec, 2001;27:58-63.