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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)
References
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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