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April 26, 2005

Herceptin® Combined With Chemotherapy Improves Disease-Free Survival for Patients With Early-Stage Breast Cancer

Topics: Clinical Pharmacology

Results from two large randomized clinical trials for patients with HER-2 positive invasive breast cancer show that those patients with early-stage breast cancer who received Herceptin® (trastuzumab) in combination with chemotherapy had a significant decrease in risk for breast cancer recurrence compared with patients who received the same chemotherapy without trastuzumab. 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.

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 the National Surgical Adjuvant Breast and Bowel Project (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., South San Francisco, Calif., which manufactures trastuzumab, provided the drug for the trials under the Cooperative Research and Development Agreement (CRADA) with NCI for the clinical development of trastuzumab.

(...) Patients in the clinical trials who received trastuzumab in combination with standard combination chemotherapy had a 52 percent decrease in disease recurrence compared to patients treated with chemotherapy alone. This difference is highly statistically significant. "This is a major advance for many thousands of women with breast cancer," said NCI Director Andrew C. von Eschenbach, M.D. "These results are one more example that we are at a major turning point in the use of targeted therapies to eliminate suffering and death from cancer," he added.

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cross posted at NewHopeBlog

Posted by Hyscience at April 26, 2005 10:41 AM



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