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| |  ASCO: Fareston (Toremifene Citrate) as Effective as Tamoxifen in Breast Cancer NEW ORLEANS, LA -- May 23, 2000 -- Data presented at the 36th Annual American Society of Clinical Oncology meeting, demonstrate that the use of Shire Roberts' Fareston (toremifene citrate) as adjuvant treatment for breast cancer in post-menopausal women is at least as safe and effective as tamoxifen. The trial, conducted by The Finnish Breast Cancer Group, is the first clinical trial to compare the efficacy and safety of Fareston to tamoxifen in the adjuvant treatment setting for post-menopausal women with axillary node-positive breast cancer. "The results of this study are of significant importance because they show that Fareston is as effective as tamoxifen in the adjuvant treatment of breast cancer," said Dr. Kaija Holli, Professor, Department of Oncology at Tampere University Hospital and Lead Investigator for the Finnish Breast Cancer Group trial. One-thousand-four-hundred and eighty patients were randomized into one of two groups receiving Fareston (40 mg/day) or tamoxifen (20 mg/day: 2-10 mg doses/day) for three years. The average follow-up time for the 899 patients included in the interim analysis presented today was 3.4 years. According to data presented the subjective side effect profile was similar (no statistically significant difference) in both treatment groups (i.e.: sweating and hot flashes) as well as the mean time to breast cancer recurrence. However, the breast cancer recurrence rate and death from breast cancer was lower in the Fareston treatment group (23.1 percent and 5.3 percent, respectively) compared to the tamoxifen treatment group (26.1 percent and 9.6 percent). Fareston is an anti-estrogenic treatment for breast cancer that has been available in the U.S. since 1997. It is currently indicated for the treatment of metastatic breast cancer in post-menopausal women with estrogen receptor positive or unknown tumors. "This is very exciting news about Fareston because it suggests that this product may provide patients with an alternative treatment option with a good safety profile and potential cost benefits," said Dr. Michael J. Edwards, Associate Professor, Department of Surgery, Division of Surgical Oncology at the University of Louisville and Chairman of the North American Fareston versus Tamoxifen Adjuvant trial for Breast Cancer (NAFTA trial). "These results are promising and I look forward to continuing to work with my colleagues in the U.S. on the NAFTA trial, which should provide additional support of Fareston as a safe and effective adjuvant treatment for breast cancer in comparison to the current standard of care." The North American Fareston versus Tamoxifen Adjuvant trial for Breast Cancer (NAFTA trial) was initiated in 1998 to compare the clinical efficacy and safety profile of Fareston adjuvant treatment to tamoxifen adjuvant treatment. The NAFTA trial is designed to have 1,980 participants randomized to receive Fareston (60 mg/day) for five years or tamoxifen (20 mg/day) for five years, with a five-year follow-up. The NAFTA trial currently has 114 clinical investigation sites recruiting patient participation "We are very pleased with the results of this study that will reinforce what is known about the efficacy and safety of Fareston therapy," said Simon Tulloch, MD, Senior Vice President of Research and Development for Shire Pharmaceutical Development in the USA. "Shire is committed to ensuring that all patients who need and want to take Fareston have access to the medication." Shire Pharmaceuticals Group is an international specialty pharmaceutical company with a strategic focus on four therapeutic areas: central nervous system disorders, metabolic diseases, oncology, and gastroenterology. Shire has sales and marketing infrastructure supporting a broad portfolio of products in the United States, Canada, United Kingdom, Republic of Ireland, France, Germany, and Italy. Shire's global search and development expertise has already provided three marketed products, while the current pipeline of thirteen projects includes one product in registration and a significant number advanced beyond Phase II. In 1999, Shire merged with Roberts Pharmaceutical Corporation. Related Links: Fareston (toremifene citrate) and Tamoxifen.
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