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Former Member
Cruncher Joined: May 22, 2018 Post Count: 0 Status: Offline |
About breast cancer and Herceptin
Eight to nine percent of women will develop breast cancer during their lifetime, making it one of the most common types of cancer in women.3 Each year more than one million new cases of breast cancer are diagnosed worldwide, with a death rate of nearly 400,000 people per year. In HER2-positive breast cancer, increased quantities of the HER2 protein are present on the surface of the tumour cells. This is known as ‘HER2 positivity.' High levels of HER2 are present in a particularly aggressive form of the disease which responds poorly to chemotherapy. Research shows that HER2-positivity affects approximately 20-30% of women with breast cancer. 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 also 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. About Roche Headquartered in Basel, Switzerland, Roche is one of the world's leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As a supplier of innovative products and services for the early detection, prevention, diagnosis and treatment of disease, the Group contributes on a broad range of fronts to improving people's health and quality of life. Roche is a world leader in diagnostics, the leading supplier of medicines for cancer and transplantation and a market leader in virology. In 2004 sales by the Pharmaceuticals Division totalled 21.7 billion Swiss francs, while the Diagnostics Division posted sales of 7.8 billion Swiss francs. Roche employs roughly 65,000 people in 150 countries and has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai. Additional information about the Roche Group is available on the Internet (http://www.roche.com). All trademarks used or mentioned in this release are legally protected. References: 1. Collaborative partners for the HERA study include: Roche, the Breast International Group (BIG) and its affiliated collaborative groups, plus non-affiliated collaborative groups, and independent sites 2. Harries M, Smith I. The development and clinical use of trastuzumab (Herceptin). Endocr Relat Cancer 9: 75-85, 2002. 3. World Health Organization, 2000 http://www.roche.com |
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Former Member
Cruncher Joined: May 22, 2018 Post Count: 0 Status: Offline |
Results from two clinical trials show that patients with early-stage breast cancer who received trastuzumab (Herceptin®) in combination with chemotherapy had a 52 percent decrease in risk for breast cancer recurrence, compared with patients who received the same chemotherapy without the drug. The difference is statistically highly significant.
Dr. Edward Romond, associate professor of medicine at the University of Kentucky College of Medicine and UK Markey Cancer Center, acts as principal investigator on the study and the National Surgical Adjuvant Breast and Bowel Project (NSABP) study chair. "For women with this type of aggressive breast cancer, the addition of trastuzumab to chemotherapy appears to virtually reverse prognosis from unfavorable to good. We owe a huge debt of gratitude to the women whose participation in these trials has made it possible to show the substantial benefit of combining trastuzumab with chemotherapy for adjuvant treatment of women with HER-2 positive breast cancer," said Romond. The clinical trials were sponsored by the National Cancer Institute (NCI), part of the National Institutes of Health, and conducted by a network of researchers led by NSABP and the North Central Cancer Treatment Group (NCCTG), in collaboration with the Cancer and Leukemia Group B, the Eastern Cooperative Oncology Group, and the Southwest Oncology Group. Genentech Inc., which manufactures trastuzumab as Herceptin®, provided the drug for the trials under the Cooperative Research and Development Agreement with NCI. Information from over 3,300 patients enrolled in the studies was used for analysis. Patients with operable breast cancer, whose tumors over-expressed HER-2, were enrolled in these studies between February 2000 and April 2005. Patients are considered "HER-2 positive" if their cancer cells "overexpress," or make too much of, a protein called HER-2, which is found on the surface of cancer cells. Trastuzumab slows or stops the growth of these cells, and it is only used to treat cancers that overexpress the HER-2 protein. Approximately 20 percent to 30 percent of breast cancers overexpress HER-2. These tumors tend to grow faster and are generally more likely to recur than tumors that do not overproduce HER-2. Trastuzumab is an example of a "targeted" therapy -- an agent that is directed against a specific change in the cancer cell. Trastuzumab was approved for the treatment of advanced breast cancer in 1998. An estimated 211,240 women will be diagnosed with breast cancer in the United States in 2005. Of these, about 30 percent have lymph node-positive breast cancer, and about 20 percent to 30 percent of these tumors overexpress the HER-2 protein, the target for trastuzumab. Breast cancer is the most commonly diagnosed cancer in women and the second leading cause of cancer-related death in women in this country. An estimated 40,110 deaths from female breast cancer will occur in 2005 in the United States, accounting for about 15 percent of all cancer-related deaths in women in the nation. Contact: Louise DuPont mldupo00@email.uky.edu 859-323-6363 University of Kentucky http://www.uky.edu |
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