LYCOS RETRIEVER 
Herceptin
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Herceptin is a humanised antibody, designed to target and block the function of HER2, a protein produced by a specific gene with cancer-causing potential. Herceptin has demonstrated improved survival in the advanced (metastatic) setting, where its addition to chemotherapy allows patients to live up to one-third longer than chemotherapy alone. Herceptin received approval in the European Union in 2000 for use in patients with metastatic breast cancer, whose tumours overexpress the HER2 protein. In addition to being indicated for use in combination with docetaxel as a first-line therapy in HER2-positive patients who have not received chemotherapy for their metastatic disease, it is ... indicated as a first-line therapy in combination with paclitaxel where anthracyclines are unsuitable, and as a single agent in second- and third-line therapy. Herceptin is marketed in the United States by Genentech, in Japan by Chugai and internationally by Roche. Since 1998, Herceptin has been used to treat over 230,000 HER2-positive breast cancer patients worldwide.
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The drug Herceptin is a monoclonal antibody engineered through biotechnology. It targets breast cancer cells that have too many copies of the HER2 protein. After it has identified which cells over-express the HER2 protein, Herceptin attaches itself to the HER2 protein receptors on the surface of these cells. By binding to the cells, Herceptin slows the growth and spread of tumors that have an overabundance of HER2. Many experts believe that Herceptin represents the future direction of breast cancer drugs in that it targets a particular protein of the cancer cell and prevents it from carrying out its action, similar to the new leukemia drug, Gleevec. Herceptin is given intravenously (through the vein) in an outpatient clinical setting.
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The women who responded best to Herceptin had the highest levels of HER2 protein. Testing of tumors from women with metastatic breast cancer is critical for the identification of patients who over express HER2 and who can potentially benefit from treatment with Herceptin. A new test, the DAKO HercepTest, to measure HER2 protein in tumors and help identify patients who may benefit from Herceptin is available.
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In the chemo plus Herceptin arm, 21% of women had a nadir LVEF which was <lower limit of normal or >15 points drop from baseline. No clinical cardiac events occurred in the control arm at the interim analysis compared to 3.3% patients developing CHF or a drop below the pre-specified LVEF boundary prompting an interruption in study drug. Therefore, adding Herceptin to chemotherapy causes a predictable increase in cardiac events but acceptable based on the large clinical benefit. The relatively high incidence of changes in LVEF strongly documents the need to monitor patients carefully during Herceptin therapy.
Future Uses The response seen with Herceptin in metastatic disease warrants further research in the adjuvant setting. The National Surgical Adjuvant Breast and Bowel Project (NSABP) have therefore begun a phase III trial involving more than 100 centres. The trial aims to enrol 2700 women with node-positive HER2-positive breast cancer over five years. The control group will receive four cycles of AC followed by four cycles of Taxol. The study group will ... receive H. Patients with ER- and/or Pgr-positive tumours will also receive tamoxifen. Further information on this trial can be obtained from the following web-site: http://cancer trial.nci.nih.gov.
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Herceptin is a targeted therapy against the HER2 protein on cancer cells. When an excessive amount of HER2 protein is present, it causes cancer cells to grow more rapidly and standard chemotherapy may be less effective. In 1998, FDA approved Herceptin for the treatment of metastatic breast cancer (cancer that has spread to other sites in the body). In the United States there are an estimated 212, 920 new cases of breast cancer and about 40,970 related deaths each year. Approximately 25 percent of women with breast cancer will have tumors that produce excessive amounts of HER2 protein.
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Herceptin