Use of trastuzumab for the treatment of early stage breast cancer

Expert Review of Anticancer Therapy

Volumn 6, Issue 8, 2006, Pages 1153-1164

  Braga, Sofia ^a   dal Lago, Lissandra ^a   Bernard, Chantal ^a   Cardoso, Fátima ^a   Piccart, Martine ^a  

^a JULES BORDET INSTITUTE   (Belgium)

Author keywords

Adjuvant treatment; Cardiotoxicity; Early breast cancer; HER 2; Trastuzumab

Indexed keywords

ANTHRACYCLINE DERIVATIVE; ANTINEOPLASTIC AGENT; CARBOPLATIN; CISPLATIN; CYCLOPHOSPHAMIDE; DOCETAXEL; DOXORUBICIN; EPIDERMAL GROWTH FACTOR RECEPTOR 2; EPIRUBICIN; ESTROGEN RECEPTOR; FLUOROURACIL; HORMONE; NAVELBINE; PACLITAXEL; PLATINUM DERIVATIVE; PROGESTERONE RECEPTOR; PROTEIN TYROSINE KINASE; TAMOXIFEN; TAXANE DERIVATIVE; TRASTUZUMAB;

ANGINA PECTORIS; ARTICLE; BREAST CANCER; CANCER ADJUVANT THERAPY; CANCER CELL; CANCER HORMONE THERAPY; CANCER RECURRENCE; CANCER STAGING; CARDIOTOXICITY; CELL SURFACE; CLINICAL TRIAL; CONGESTIVE HEART FAILURE; CORONARY ARTERY DISEASE; COST EFFECTIVENESS ANALYSIS; DISEASE FREE SURVIVAL; DRUG APPROVAL; DRUG COST; DRUG DOSE REGIMEN; DRUG FATALITY; DRUG POTENTIATION; FOLLOW UP; GENE OVEREXPRESSION; HEART ARRHYTHMIA; HEART DEATH; HEART DISEASE; HEART INFARCTION; HUMAN; HYPERTENSION; METASTASIS POTENTIAL; MORTALITY; PROGNOSIS; PROTEIN EXPRESSION; RISK ASSESSMENT; VALVULAR HEART DISEASE;

ANTIBODIES, MONOCLONAL; ANTINEOPLASTIC AGENTS; BREAST NEOPLASMS; FEMALE; HUMANS; IN SITU HYBRIDIZATION, FLUORESCENCE; MULTICENTER STUDIES; NEOPLASM STAGING; RANDOMIZED CONTROLLED TRIALS; RECEPTOR, ERBB-2; RECURRENCE;

EID: 33748115504     PISSN: 14737140     EISSN: 17448328     Source Type: Journal    
DOI: 10.1586/14737140.6.8.1153     Document Type: Article

References (77)

1. Coleman MP, Gatta G, Verdecchia A (and the EUROCARE Working Group). EUROCARE-3 summary: cancer survival in Europe at the end of the 20th century. Ann. Oncol. 14, 128-149 (2003).
2. Schechter AL, Stern DF, Vaidyanathan L et al The neu oncogene: an erb-B-related gene encoding a 185,000-Mr tumour antigen. Nature 312(5994), 513-516 (1984).
3. Schechter AL, Hung MC, Vaidyanathan L et al. The neu gene: an erbB-homologous gene distinct from and unlinked to the gene encoding the EGF receptor. Science 229 (4717), 976-978 (1985).
4. King CR, Kraus MH, Aaronson SA. Amplification of a novel v-erbB-relted gene in a human mammary carcinoma. Science 229(4717),974-976 (1985).
5. Slamon DJ, Clark GM, Wong SG, Levin WJ, Ullrich A, McGuire WL. Human breast cancer: correlation of relapse and survival with amplification of the HER-2/neu oncogene. Science 235(4785), 177-182 (1987).
6. Slamon DJ, Godolphin W, Jones LA. Studies of the HER-2/neu proto-oncogene in human breast and ovarian cancer. Science 244(4905), 707-712 (1989).
7. 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 230(4730), 1132-1139 (1985).
8. Shih C, Padhy LC, Murray M, Weinberg RA. Transforming genes of carcinomas and neuroblastomas introduced into mouse fibroblasts. Nature 290(5803), 261-264 (1981).
9. Fendly BM, Winget M, Hudziak RM et al. Characterization of murine monoclonal antibodies reactive to either the human epidermal growth factor receptor or HER2/neu gene product. Cancer Res. 50 (5), 1550-1558 (1990).
10. Hudziak RM, Lewis GD, Winget M, Fendly BM, Shepard HM, Ullrich A. p185HER2 monoclonal antibody has antiproliferative effects in vitro and sensitizes human breast tumor cells to tumor necrosis factor. Mol. Cell. Biol. 9, 1165-1172 (1989).
11. Konecny G, Fritz M, Untch M et al. HER-2/neu overexpression and in vitro chemosensitivity to CMF and FEC in primary breast cancer. Breast Cancer Res. Treat. 69,53-63 (2001).
12. Pegram M, Hsu S, Lewis G et al. Inhibitory effects of combinations of HER-2/neu antibody and chemotherapeutic agents used for treatment of human breast cancers. Oncogene 18,2241-2251 (1999).
13. Pegram MD, Lopez A, Konecny G, Slamon DJ. Trastuzumab and chemotherapeutics: drug interactions and synergies. Semin. Oncol. 27,21-25 (2000).
14. Baselga J, Norton L, Albanell J, Kim YM, Mendelsohn J. Recombinant humanized anti-HER2 antibody (Herceptin) enhances the antitumor activity of paclitaxel and doxorubicin against HER2/neu-overexpressing human breast cancer xenografts. Cancer Res. 58, 2825-2831 (1998).
15. 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. 17,2639-2648 (1999).
16. Vogel CE, 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. 20,719-726 (2002).
17. Mass R, Press M, Anderson S et al. Evaluation of clinical outcomes according to HER2 detection by FISH in women with metastatic breast cancer. Clin. Breast Cancer 6(3),240-246 (2005).
18. 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. 344,783-792 (2001).
19. Eisenhauer E. From the molecule to the clinic - inhibiting HER2 to treat breast cancer. N. Engl. J. Med. 344,841-842 (2001).
20. Pegram MD, Pienkowski T, Nothfelt D et al. Results of two open-label multicenter phase II studies of docetaxel, platinum salts, and trastuzumab in HER2-positive advanced breast cancer. J. Natl Cancer Inst. 96,759-769 (2004).
21. Rowland KM, Suman VJ, Ingle JN et al. NCCTG 98-32-52: randomized Phase II trial of weekly versus every 3-week administration of paclitaxel, carboplatin and trastuzumab in women with HER2 positive metastatic breast cancer (MBC). Proc. Am. Soc. Clin. Oncol. 22,8 (2003).
22. Robert NJ, Leyland-Jones B, Asmar L et al. Randomized Phase III study of trastuzumab, paclitaxel, and carboplatin versus trastuzumab and paclitaxel in women with HER-2 overexpressing metastatic breast cancer: an update including survival. Proc. Am. Soc. Clin. Oncol. Abstract 573 (2004).
23. Leyland-Jones B, Gelmon K, Ayoub JP et al. Pharmacokinetics, safety, and efficacy of trastuzumab administered every three weeks in combination with paclitaxel. J. Clin. Oncol. 21(21),3965-3971 (2003).
24. Leyland-Jones B. Dose scheduling - herceptin. Oncology 61(Suppl. 2),31-36 (2001).
25. Baselga J, Carbonell X, Castaneda-Soto NJ et al. Phase II study of efficacy, safety, and pharmacokinetics of trastuzumab monotherapy administered on a 3-weekly schedule. J. Clin. Oncol. 23(10), 2162-2171 (2005).
26. Yaziji H, Goldstein LC, Barry TS et al. HER-2 testing in breast cancer using parallel tissue-based methods. JAMA 291(16), 1972-1977 (2004).
27. 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. 18(21), 3651-3664 (2000).
28. Press MF, Slamon DJ, Flom KJ, Park J, Zhou JY, Bernstein L. 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. 20(14), 3095-3105 (2002).
29. Larsimont D, Di Leo A, Rouas G et al. HER-2/neu evaluation by immunohistochemistry and fluorescence in situ hybridization in breast cancer: implications for daily laboratory practice. Anticancer Res. 22(4), 2485-2490 (2002).
30. 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. 19(10), 2714-2721 (2001).
31. 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. 19(10), 2587-2595 (2001).
32. 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. 19(2), 354-363 (2001).
33. Roche PC, Suman VJ, Jenkins RB et al. Concordance between local and central laboratory HER2 testing in the breast intergroup trial N9831. J. Natl. Cancer Inst. 94(11), 855-857 (2002).
34. 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. 94(11), 852-854 (2002).
35. Ma Y, Lespagnard L, Durbecq V et al. Polysomy 17 in HER-2/neu status elaboration in breast cancer: effect on daily practice. Clin. Cancer Res. 11, 4393-4399 (2005).
36. Schlemmer BO, Sorensen BS, Overgaard J, Olsen KE, Gjerdrum LM, Nexo E. Quantitative PCR - new diagnostic tool for quantifying specific mRNA and DNA molecules: HER2/neu DNA quantification with LightCycler real-time PCR in comparison with immunohistochemistry and fluorescence in situ hybridization. Scand. J. Clin. Lab. Invest. 64(5), 511-22 (2004).
37. Suo Z, Daehli KU, Lindboe CF, Borgen E, Bassarova A, Nesland JM. Real-time PCR quantification of c-erbB-2 gene is an alternative for FISH in the clinical management of breast carcinoma patients. Int. J. Surg. Pathol. 12(4),311-318 (2004).
38. Gjerdrum LM, Sorensen BS, Kjeldsen E, Sorensen FB, Nexo E, Hamilton-Dutoit S. Real-time quantitative PCR of microdissected paraffin-embedded breast carcinoma: an alternative method for HER2/neu analysis. J. Mol. Diagn. 6(1),42-51 (2004).
39. Raab GH, Hoegel B, Biebl J et al. Chromogen in situ hybridisation (CISH) for HER2 assessment is highly concordant with FISH in core cut biopsies of primary T2 breast cancers. Proc. Am. Soc. Clin. Oncol. 569 (2004).
40. Vera-Roman JM, Rubio-Martinez LA. Comparative assays for the HER-2/neu oncogene status in breast cancer. Arch. Pathol. Lab. Med. 128(6),627-633 (2004).
41. Denoux Y, Arnould L, Fiche M et al. HER2 gene amplification assay: is CISH an alternative to FISH? Ann. Pathol. 23(6), 617-622 (2003).
42. The Nolvadex Adjuvant Trial Organization. Controlled trial of tamoxifen as adjuvant agent in management of early breat cancer. Lancet 19, 257-261 (1983).
43. Piccart-Gebhart MJ, Procter M, Leyland-Jones B et al. Trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer. N. Engl. J. Med. 353, 1659-1672 (2005).
44. Hortobagyi G. Trastuzumab in the treatment of breast cancer. N. Engl. J. Med. 353, 1734-1736 (2005).
45. Smith I. HERA Trial updated results. Scientific Special Session. Am. Soc. Clin. Oncol. (2006).
46. Romond EH, Perez EA, Bryant J et al. Trastuzumab plus adjuvant chemotherapy for operable HER2-positive breast cancer. N. Engl. J. Med. 353, 1673-1684 (2005).
47. Perez E, Suman V, Davidson N et al. Interim cardiac safety analysis of NCCTG N9831 Intergroup adjuvant trastuzumab trial. J. Clin. Oncol. ASCO Ann. Meeting Proc. 23(16S), 556 (2005).
48. Bendell JC, Domchek SM, Burstein HJ et al. Central nervous system metastases in women who receive trastuzumab-based therapy for metastatic breast carcinoma. Cancer 97, 2972-2977 (2003).
49. Clayton AJ, Danson S, Jolly S et al. Incidence of cerebral metastases in patients treated with trastuzumab for metastatic breast cancer. Br. J. Cancer 91, 639-643 (2004).
50. Lin NU, Bellon JR, Winer EP. CNS metastases in breast cancer. J. Clin. Oncol. 22, 3608-3617(2004).
51. Kim C, Bryant J, Horne Z et al. Trastuzumab sensitivity of breast cancer with co-amplification of HER2 and cMYC suggests pro-apoptotic function of deregulated cMYC in vivo. San Antonio Breast Cancer-Symposium Abstract 46 (2005).
52. 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. San Antonio Breast Cancer Symponum Abstract 1 (2005).
53. Joensuu H, Kellokumpu-Lehtinen P, Bono P et al. Adjuvant docetaxel or vinorelbine with or without trastuzumab for breast cancer. N. Engl. J. Med. 354(8),808-820 (2006).
54. Chien K. Herceptin and the heart - a molecular modifier of cardiac failure. N. Engl. J. Med. 354(8),789-790 (2006).
55. Mohsin S, Weiss H, Gutierrez C et al. Neoadjuvant trastuzumab induces apoptosis in primary breast cancers. J. Clin. Oncol. 23, 11, 2460-2468 (2005).
56. Gennari R, Menard S, Fagnoni F et al. Pilot study of the mechanism of action of preoperation trastuzumab in patients with primary operable breast tumors overexpressing HER2. Clin. Cancer Res. 10, 5650-5655 (2004).
57. Buzdar A, Ibrahim N, Francis D et al. Significantly higher pathologic complete remission rate after neoadjuvant therapy with trastuzumab, paclitaxel, and epirubicin chemotherapy: results of a randomized trial in human epidermal growth factor receptor 2-positive operable breast cancer. J. Clin. Oncol. 23(16),3676-3685 (2005).
58. Wenzel C, Hussian D, Bartsch R et al. Preoperative therapy with epidoxorubicin and docetaxel plus trastuzumab in patients with primary breast cancer: a pilot study. J. Cancer Res. Clin. Oncol. 130,400-404 (2004).
59. Hoffmann la Roche. Herceptin key clinical trials card, October (2004).
60. Burstein H, Harris L, Gelman R et al. Preoperative therapy with trastuzumab and paclitaxel followed by sequential adjuvant doxorubicin/ cyclophosphamide for HER2 overexpressing stage II or III breast cancer: a pilot study. J. Clin. Oncol. 21(1),46-53 (2003).
61. Hurley J, Doliny P, Reis I et al. Docetaxel, cisplatin, and trastuzumab as primary systemic therapy for human epidermal growth factor receptor 2-positive locally advanced breast cancer. J. Clin. Oncol. 24(12),1831-1838 (2006).
62. Bines J, Murad A, Lago S et al. Multicenter Brazilian study of weekly docetaxel and trastuzumab as primary therapy in stage III, HER-2 overexpressing breast cancer. Proc. Am. Soc. Clin. Oncol. 22,67(2003).
63. Coudert B, Arnould L, Moreau L et al. Pre-operative systemic (neo-adjuvant) therapy with trastuzumab and docetaxel for HER2-overexpressing stage II or III breast cancer: results of a multicenter Phase II trial. Ann. Oncol. 17(3),409-414 (2006).
64. Van Pelt AE, Mohsin S, Elledge RM et al. Neoadjuvant trastuzumab and docetaxel in breast cancer: preliminary results. Clin. Breast Cancer 4,348-353 (2003).
65. Schiffhauer LM, Griggs JJ, Ahrendt GM et al. Docetaxel and trastuzumab as primary systemic therapy for HER-2/neu-overexpressing breast cancer. Proc. Am. Soc. Clin. Oncol. 22,242 (2003).
66. + Stage II/III breast cancer. Proc. Am. Soc. Clin. Oncol. 22,22 (2003).
67. Limentani SA, Brufsky AM, Erban JK et al. Dose dense neoadjuvant treatment of women with breast cancer utilizing docetaxel, vinorelbine and trastuzumab with growth factor support. Br. Cancer Res. Treat. 82, S55 (2003).
68. Seidman A, Hudis C, Pierri M et al. Cardiac dysfunction in the trastuzumab clinical trials experience. J. Clin. Oncol. 20(5), 1215-1221 (2002).
69. Tan-Chiu E, Yothers G, Romond E et al. Assessment of cardiac dysfunction in a randomized trial comparing doxorubicin and cyclophosphamide followed by paclitaxel, with or without trastuzumab as adjuvant therapy in node-positive, human epidermal growth factor receptor 2-overexpressing breast cancer: NSABP B-31 J. Clin. Oncol. 23(31), 7811-7819 (2005).
70. Ozcelik C, Erdmann B, Pilz B et al. Conditional mutation of the ErbB2 (HER2) receptor in cardiomyocytes leads to dilated cardiomyopathy. Proc. Natl Acad. Sci. USA 99(13), 8880-8885 (2002).
71. Ewer M, Lippman S. Type II chemotherapy-related cardiac dysfunction: time to recognize a new entity. J. Clin. Oncol. 23(13), 2900-2902 (2005).
72. Gopalakrishan S, Linnane J. The other side of the coin. Br. Med. J. 331, 1202-1203 (2005).
73. Littlejohns P. Trastuzumab for early breast cancer: evolution or revolution? Lancet Oncol. 7(1), 22-23 (2006).
74. Neyt M, Albrecht A, Cocquyt VF. An economic evaluation of Herceptin in adjuvant setting: the Breast Cancer International Research Group 006 trial. Ann. Oncol. 17, 381-390 (2006).
75. Ismael G. Breast International Group Newsletter, Spring (2006).
76. Pestalozzi BC, Brignoli S. Trastuzumab in CSF. J. Clin. Oncol. 18(11),2349-2351 (2000).
77. Smith I. Trastuzumab for early breast cancer. Lancet 367, 106-107 (2006).