Register for ASCO assesses updated trial results on Arimidex use for early breast cancer
American Society of Clinical OncologyJune 11, 2003
2003 JUN 11 - (NewsRx.com & NewsRx.net) -- The Technology Assessment Working Group of the American Society of Clinical Oncology (ASCO) voted unanimously to support and maintain their recommendation issued last year regarding Arimidex (anastrozole) Tablets use in postmenopausal women with hormone receptor-positive early breast cancer, as posted on the website of the Journal of Clinical Oncology ( www.jco.org ), and to be published in the July 1, 2003, issue.
The Working Group indicated that the 47-month follow-up data from the Arimidex early breast cancer trial (ATAC - Arimidex, Tamoxifen, Alone or in Combination) provide "a greater level of assurance, in terms of both toxicity and efficacy, for physicians and their patients who are considering the use of anastrazole (Arimidex) in the adjuvant setting."
They noted that the updated data continue to support their previous recommendation that Arimidex be considered for postmenopausal women with hormone receptor-positive early breast cancer who may be at high risk for some of the side effects associated with tamoxifen, such as blood clots and stroke. Arimidex is the only hormonal drug other than tamoxifen that has been approved for use in the adjuvant setting.
The adjuvant treatment indication for Arimidex was approved in September 2002 by the U.S. Food and Drug Administration (FDA) for treatment following surgery with or without chemotherapy and radiation in postmenopausal women with hormone receptor-positive early breast cancer. The effectiveness of Arimidex is based on an analysis of recurrence-free survival from the ongoing Arimidex early breast cancer trial (ATAC) in patients taking Arimidex as treatment following surgery with or without chemotherapy and radiation for a median of 2.5 years, and thus allows only a preliminary comparison with tamoxifen.
Further follow-up of patients in this ongoing study will be required to determine long-term results, including side effects and survival. The 47-month follow-up data showed no substantial difference in either efficacy or toxicity from the 33-moth data, and there are too few events for a mature survival analysis between Arimidex and tamoxifen groups.
"Arimidex offers women a treatment option other than tamoxifen," said principal U.S. investigator Aman Buzdar, MD, of The University of Texas MD Anderson Cancer Center, Houston, Texas. "Because Arimidex continues to show improvement over tamoxifen, more and more physicians may discuss Arimidex as an option with their early breast cancer patients."
"Arimidex gave me an alternative choice to tamoxifen," said breast cancer survivor, Marlene Calderone. "My physician and I discussed both options and Arimidex was the best fit for me. With Arimidex, I am fighting the recurrence of my disease."
Last year at ASCO's annual meeting, the Working Group presented its Technology Assessment report, noting that Arimidex is the only aromatase inhibitor with clinical trial data in the adjuvant setting and it should be considered the preferred agent if an aromatase inhibitor is used in the treatment of patients with early breast cancer. They also noted that physicians and patients need to come to their own conclusions after considering all available data. This article was prepared by Biotech Week editors from staff and other reports.
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