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New Indication for Breast Cancer Drug, Arimidex(TM), Offers New Treatment Choice for Tamoxifen Patients in EuropeNew Indication for Breast Cancer Drug, Arimidex(TM), Offers New Treatment Choice for Tamoxifen Patients in Europe
Macclesfield, England (ots/PRNewswire) -
- Thousands More Women Will Have the Opportunity to Take 'Arimidex' as Part of Their Breast Cancer Treatment and Improve Their Chances of Living Longer, Cancer Free
- For Health Professional and Consumer Press
- For International Journalists - Not for US Media
From today, breast cancer patients currently taking the hormonal treatment tamoxifen have a new opportunity to improve their likelihood of living longer, cancer free by changing to a different kind of treatment, 'Arimidex' (anastrozole).(1) Anastrozole has already been shown to be significantly more effective than tamoxifen in preventing recurrence of early-stage breast cancer in postmenopausal women(2), but until now, had only been licensed for use directly after breast cancer surgery, in patients newly diagnosed with the disease (known as primary adjuvant treatment). The new indication for anastrozole makes it the first and only aromatase inhibitor to be approved both for primary adjuvant use and following 2-3 years of tamoxifen.
"Physicians are increasingly using anastrozole at diagnosis because of its superior efficacy and tolerability compared with the old gold standard tamoxifen," commented Prof. Walter Jonat of University of Kiel, Germany. "The question remained whether those patients who did not receive anastrozole from the start of their treatment would still be able to benefit. This new indication means we can now also offer them a greater likelihood of living longer, cancer free, by changing therapy to anastrozole. It will also reduce the risk of patients experiencing some of the long-term side effects associated with tamoxifen," he continued.
Anastrozole belongs to a group of drugs called aromatase inhibitors (AIs) and works in a different way to tamoxifen. Results from the world's largest and longest-running breast cancer trial to report mature data, the ATAC* trial(2), have conclusively demonstrated that women who take anastrozole instead of tamoxifen following surgery are more likely to stay cancer-free and not be burdened by serious side effects. However, these results are only relevant for women who have just been diagnosed with early breast cancer and do not apply to those who have already partially completed a course of treatment with tamoxifen.
The new indication for anastrozole is based on extensive data from three additional clinical trials, run by independent, international, collaborative groups. The ABCSG-8, ARNO 95 and ITA** trials were specifically designed to investigate the effects of changing treatments in women already receiving tamoxifen for early breast cancer. The collaborative groups' analysis of the ARNO study showed that changing from tamoxifen to anastrozole can significantly improve a woman's likelihood of living longer cancer free, compared with continued tamoxifen (3-7).
The new indication for anastrozole has been granted in the EU Mutual Recognition markets: the UK, Germany, Austria, Portugal, Italy and Spain. In these countries, anastrozole is now indicated for the adjuvant treatment of early breast cancer in hormone receptor positive postmenopausal women who have received 2 to 3 years of adjuvant tamoxifen.
With over two million patient years experience, anastrozole is now the world's most used AI. It was first approved for the primary adjuvant treatment of early breast cancer in 2002 and is now approved for this indication world-wide. It is the only AI that has been confirmed superior to tamoxifen when used over the full recommended five-year treatment period, as demonstrated by the Completed Treatment Analysis of the ATAC trial.(2) Anastrozole is also the only AI with comprehensive tolerability data extending over the full 5-year treatment period and an established and reassuring benefit: risk profile in the primary adjuvant setting.(2)
1. 'Arimidex' (anastrozole) UK Summary of Product Characteristics (UKSmPC) 30 June 2006
2. ATAC Trialists' Group. Results of the ATAC (Arimidex, Tamoxifen, Alone or in Combination) trial after completion of 5 years' adjuvant treatment for breast cancer. Lancet, 365 (9453): 60-62.
3. Jakesz R et al. Switching of postmenopausal women with endocrine-responsive early breast cancer to anastrozole after 2 years' adjuvant tamoxifen: combined results of ABCSG trial 8 and ARNO 95 trial. Lancet 2005; 366: 455-462
4. Boccardo F et al. Switching to anastrozole versus continued tamoxifen treatment of early breast cancer: preliminary results of the Italian Tamoxifen Anastrozole trial. J Clin Oncol 2005; 23: 5138-5147.
5. Boccardo F et al. Switching to anastrozole (ANA) vs continued tamoxifen (TAM) treatment of early breast cancer (EBC). Updated results of the Italian tamoxifen anastrozole (ITA) trial. J Clin Oncol (Meeting Abstracts) 2005; 23: 10s, abs 526.
6. Jonat W et al. Switching from adjuvant tamoxifen to anastrozole in postmenopausal women with hormone-responsive early breast cancer: a meta-analysis of the ARNO 95 trial, ABCSG Trial 8, and the ITA trial. Abstract No. 18. San Antonio Breast Cancer Symposium 2005.
7. Kaufmann M et al. Survival benefit of switching to anastrozole after 2 year's treatment with tamoxifen versus continued tamoxifen therapy: The ARNO 95 study. J Clin Oncol (Meeting Abstracts) 2005; 24:14s, abs 547.
Notes to Editors
* ATAC Trial: 'Arimidex' Tamoxifen, Alone or in Combination
** ABCSG 8 - Austrian Breast & Colorectal Cancer Study Group Trial 8
ARNO 95 - 'Arimidex', 'Nolvadex' 95 Study
ITA - Italian Tamoxifen Anastrozole
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