Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2
- PMID: 11248153
- DOI: 10.1056/NEJM200103153441101
Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2
Abstract
Background: The HER2 gene, which encodes the growth factor receptor HER2, is amplified and HER2 is overexpressed in 25 to 30 percent of breast cancers, increasing the aggressiveness of the tumor.
Methods: We evaluated the efficacy and safety of trastuzumab, a recombinant monoclonal antibody against HER2, in women with metastatic breast cancer that overexpressed HER2. We randomly assigned 234 patients to receive standard chemotherapy alone and 235 patients to receive standard chemotherapy plus trastuzumab. Patients who had not previously received adjuvant (postoperative) therapy with an anthracycline were treated with doxorubicin (or epirubicin in the case of 36 women) and cyclophosphamide alone (138 women) or with trastuzumab (143 women). Patients who had previously received adjuvant anthracycline were treated with paclitaxel alone (96 women) or paclitaxel with trastuzumab (92 women).
Results: The addition of trastuzumab to chemotherapy was associated with a longer time to disease progression (median, 7.4 vs. 4.6 months; P<0.001), a higher rate of objective response (50 percent vs. 32 percent, P<0.001), a longer duration of response (median, 9.1 vs. 6.1 months; P<0.001), a lower rate of death at 1 year (22 percent vs. 33 percent, P=0.008), longer survival (median survival, 25.1 vs. 20.3 months; P=0.01), and a 20 percent reduction in the risk of death. The most important adverse event was cardiac dysfunction of New York Heart Association class III or IV, which occurred in 27 percent of the group given an anthracycline, cyclophosphamide, and trastuzumab; 8 percent of the group given an anthracycline and cyclophosphamide alone; 13 percent of the group given paclitaxel and trastuzumab; and 1 percent of the group given paclitaxel alone. Although the cardiotoxicity was potentially severe and, in some cases, life-threatening, the symptoms generally improved with standard medical management.
Conclusions: Trastuzumab increases the clinical benefit of first-line chemotherapy in metastatic breast cancer that overexpresses HER2.
Comment in
-
Trastuzumab and breast cancer.N Engl J Med. 2001 Sep 27;345(13):995-6. doi: 10.1056/NEJM200109273451312. N Engl J Med. 2001. PMID: 11575295 No abstract available.
-
Trastuzumab and breast cancer.N Engl J Med. 2001 Sep 27;345(13):996. N Engl J Med. 2001. PMID: 11575296 No abstract available.
-
Trastuzumab and breast cancer.N Engl J Med. 2001 Sep 27;345(13):996-7. N Engl J Med. 2001. PMID: 11575297 No abstract available.
Similar articles
-
Trastuzumab plus adjuvant chemotherapy for operable HER2-positive breast cancer.N Engl J Med. 2005 Oct 20;353(16):1673-84. doi: 10.1056/NEJMoa052122. N Engl J Med. 2005. PMID: 16236738 Clinical Trial.
-
First-line trastuzumab plus epirubicin and cyclophosphamide therapy in patients with human epidermal growth factor receptor 2-positive metastatic breast cancer: cardiac safety and efficacy data from the Herceptin, Cyclophosphamide, and Epirubicin (HERCULES) trial.J Clin Oncol. 2010 Mar 20;28(9):1473-80. doi: 10.1200/JCO.2009.21.9709. Epub 2010 Feb 22. J Clin Oncol. 2010. PMID: 20177030 Clinical Trial.
-
Pathological complete response and prognosis in patients receiving neoadjuvant paclitaxel and trastuzumab with and without anthracyclines for stage II and III, HER2-positive operable breast cancer: a single-institute experience.Anticancer Res. 2011 Sep;31(9):3041-6. Anticancer Res. 2011. PMID: 21868556
-
Trastuzumab, a recombinant DNA-derived humanized monoclonal antibody, a novel agent for the treatment of metastatic breast cancer.Clin Ther. 1999 Feb;21(2):309-18. doi: 10.1016/S0149-2918(00)88288-0. Clin Ther. 1999. PMID: 10211534 Review.
-
[Human recombinant anti-HER2 monoclonal antibody--a new targeted treatment in breast cancer].Orv Hetil. 2001 Nov 18;142(46):2563-8. Orv Hetil. 2001. PMID: 11770175 Review. Hungarian.
Cited by 2,582 articles
-
Assessment of Cellular Uptake Efficiency According to Multiple Inhibitors of Fe3O4-Au Core-Shell Nanoparticles: Possibility to Control Specific Endocytosis in Colorectal Cancer Cells.Nanoscale Res Lett. 2020 Aug 17;15(1):165. doi: 10.1186/s11671-020-03395-w. Nanoscale Res Lett. 2020. PMID: 32804261 Free PMC article.
-
Novel targeted therapies for metastatic breast cancer.Ann Transl Med. 2020 Jul;8(14):907. doi: 10.21037/atm.2020.03.43. Ann Transl Med. 2020. PMID: 32793751 Free PMC article. Review.
-
Trastuzumab increases pulmonary vein arrhythmogenesis through modulating pulmonary vein electrical and conduction properties via phosphatidylinositol 3-kinase signaling.Iran J Basic Med Sci. 2020 Jul;23(7):865-870. doi: 10.22038/ijbms.2020.44651.10432. Iran J Basic Med Sci. 2020. PMID: 32774807 Free PMC article.
-
H2Mab-19, an anti-human epidermal growth factor receptor 2 monoclonal antibody exerts antitumor activity in mouse oral cancer xenografts.Exp Ther Med. 2020 Aug;20(2):846-853. doi: 10.3892/etm.2020.8765. Epub 2020 May 18. Exp Ther Med. 2020. PMID: 32765652 Free PMC article.
-
Targeted therapies in gynecological cancers: a comprehensive review of clinical evidence.Signal Transduct Target Ther. 2020 Jul 29;5(1):137. doi: 10.1038/s41392-020-0199-6. Signal Transduct Target Ther. 2020. PMID: 32728057 Free PMC article. Review.
Publication types
MeSH terms
Substances
LinkOut - more resources
-
Full Text Sources
-
Other Literature Sources
-
Medical
-
Molecular Biology Databases
-
Research Materials
-
Miscellaneous