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New data presented in San Antonio Breast Cancer Conference shows Arimidex is superior compared to Tamoxifen in decreasing recurrence of breast cancer in post-menopausal women. World's largest early breast cancer treatment trial (ATAC) reported on Dec 8, 2004 that Arimidex reduces the relative risk of breast cancer recurrence by 17% over Tamoxifen in hormone receptor-positive breast cancer patients. The study also compared the safety profile of Arimidex to Tamoxifen after 68 months of follow-up.
Arimidex and Tamoxifen are the only drugs approved by the FDA for the adjuvant (post-operative preventive) treatment of hormone receptor-positive postmenopausal women with early breast
cancer. The risk of recurrence of breast cancer is highest in the first 5 years following diagnosis, and these drugs are given during this period.
The U.S. Food and Drug Administration (FDA) has already approved Arimidex for the adjuvant treatment of hormone receptor-positive early breast cancer in postmenopausal women. This was based on the findings from the same study, which was presented in the previous years after a follow up of 31 months. The current data is based on follow up of 68 months. This shows a 17% reduction in recurrence among patients with confirmed hormone receptor-positive tumors treated with Arimidex compared with Tamoxifen (424 of 2,618 patients on Arimidex had a
recurrence or died, compared with 497 of 2,598 patients on Tamoxifen). 84 percent of patients in the study had hormone receptor-positive tumors. There was also a 13% relative reduction in the risk of recurrence or death from any cause was seen
in the overall study population (575 of 3,125 ARIMIDEX patients compared to 651 of 3,116 Tamoxifen patients). Overall survival data show 420 deaths from any cause in the Tamoxifen arm and 411 deaths in the Arimidex arm. More than 92% of patients in the
study have completed 5 years of treatment, which is the recommended treatment duration for Tamoxifen in the adjuvant setting.
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