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New International Treatment Guidelines Verify Crucial Role of 'Arimidex'(TM) (Anastrozole) for Postmenopausal Women With Early Breast Cancer

Macclesfield, England (ots/PRNewswire)

Today, new guidelines
from the prestigious St. Gallen 'International Consensus Conference
on the Primary Therapy of Early Breast Cancer' were released ahead of
publication on the Annals of Oncology website(1). For the first time,
the St. Gallen consensus panel has confirmed that 5 years of
treatment with an aromatase inhibitor (AI), such as anastrozole, is
one of the best options for postmenopausal women with
hormone-sensitive disease to protect against their cancer returning
following surgery. A change in these treatment guidelines means more
patients should now be offered the opportunity to benefit from the
proven efficacy and tolerability advantages of anastrozole, allowing
them to continue to live free of cancer for longer.
"The St. Gallen guidelines now recognise the crucial benefits that
AIs, such as anastrozole, can offer to women in the primary adjuvant
setting. They are the first international guidelines to be updated
since the publication of the ATAC 5-year Completed Treatment Analysis
- data that are already leading to the routine use of anastrozole, in
place of tamoxifen, over a 5-year treatment period," said Professor
Anthony Howell of Christie Hospital, Manchester, UK.
Anastrozole is the most studied of all the AIs and the only one
which has been confirmed superior to tamoxifen over the full 5-year
treatment period, as demonstrated by the results of the ATAC
('Arimidex', Tamoxifen, Alone, or in Combination) 5-year Completed
Treatment Analysis(2). Although other AIs  have been studied in the
adjuvant setting, they
do not have such conclusive long-term efficacy and tolerability
data to support their use as primary adjuvant therapy. In particular,
there is already a difference in toxicity profiles emerging between
aromatase inhibitors, with exemestane and letrozole showing early
signs of cardiac side effects when compared with tamoxifen, which has
not been seen with
anastrozole. The American Society of Clinical Oncology (ASCO)
treatment guidelines, updated at the end of 2004, favour using the
agent with the most data relevant to each
individual clinical setting and recognise that AIs should not be
used interchangeably(3). Therefore, evidence-based medicine suggests
that anastrozole should be the preferred AI to replace tamoxifen
after breast cancer surgery.
Professor Howell continued: "Although all AIs have a similar
mechanism of action, we have already seen that their toxicity
profiles may be very different when used over long periods. We have
extensive safety data for anastrozole and can be confident in its
use."
By routinely offering anastrozole following surgery for breast
cancer, doctors can provide women with the best chance of preventing
their disease returning as well as reducing their risk of many of the
serious adverse events associated with tamoxifen. Data recently
presented at the ASCO Annual Meeting in May 2005, have confirmed the
importance of starting adjuvant therapy with the most effective
treatment available(4,5,6). The risk of recurrence and serious side
effects that women experience, by taking tamoxifen in the first 2 - 3
years following surgery, cannot be offset by using an aromatase
inhibitor later in the course of treatment.
However, if a woman is already part way through a 5-year course of
tamoxifen it is not too late for her to benefit from anastrozole. The
option to switch therapy from tamoxifen to anastrozole after 2 - 3
years of treatment is also supported in the St. Gallen guidelines.
Recent studies have confirmed that changing to anastrozole can
still provide significant benefits in terms of reducing the risk of
recurrence and serious side effects(7,8).
References
1) Goldhirsch A, Glick JH, Gelber RD et al. Meeting Highlights:
International Expert Consensus on the Primary Therapy of Early Breast
Cancer 2005. Ann Oncol. 2005; 0: 3261
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 2005; 365: 60-62
3) Winer EP, Hudis C, Burstein HJ et al. American Society of
Clinical Oncology Technology Assessment on the Use of Aromatase
Inhibitors As Adjuvant Therapy for Postmenopausal Women With Hormone
Receptor-Positive Breast Cancer: Status Report 2004. J Clin Oncol
2005; 23 93: 1-11
4) Houghton J on behalf of the ATAC Trialists' Group. Using
anastrozole as initial adjuvant treatment prevents early recurrences
and reduces adverse events: Updated data from the ATAC ('Arimidex',
Tamoxifen, Alone or in Combination) trial. Proc ASCO 2005; Poster
Number: A8 Abstract No: 582
5) Duffy S on behalf of the ATAC Trialists' Group. Gynecological
adverse events including hysterectomy occur less frequently with
anastrozole than with tamoxifen: data from the ATAC ('Arimidex',
Tamoxifen, Alone or in Combination) trial. Proc ASCO 2005
6) Cuzick JM, Howell A. Optimal timing of the use of an aromatase
inhibitor in the adjuvant treatment of postmenopausal hormone
receptor-positive breast cancer. Proc ASCO 2005; Poster Number: J17
Abstract No: 658
7) Jakesz R, Jonat W, Gnant M 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: 455-62
8) Boccardo F. Switching to anastrozole (ANA) vs continued
tamoxifen (TAM) treatment of early breast cancer (EBC). Updated
results of the Italian tamoxifen anastrozole (ITA) trial. Proc ASCO
2005; Poster Number: 1 Abstract No: 526
Notes to Editors
AstraZeneca (LSE: AZN, NYSE: AZN)  continues its tradition of
research  excellence and innovation in oncology that led to the
development of its  current anti-cancer therapies including
'ARIMIDEX' (anastrozole), 'CASODEX'  (bicalutamide), 'FASLODEX'
(fulvestrant), 'NOLVADEX' (tamoxifen), 'ZOLADEX'  (goserelin),
'TOMUDEX' (raltitrexed) and 'IRESSA' (gefitinib) as well as a  range
of novel targeted products such as anti-proliferatives,
anti-angiogenics, vascular targeting and anti-invasive agents.
AstraZeneca  is also harnessing rational drug design technologies to
develop new  compounds that offer advantages over current cytotoxic
and hormonal  treatment options. The company has over 20 different
anti-cancer projects in  research and development.
AstraZeneca is a major international healthcare business engaged
in the research, development, manufacture and marketing of
prescription pharmaceuticals and the supply of healthcare services.
It is one of the world's leading pharmaceutical companies with
healthcare sales of over $21.4 billion and leading positions in sales
of gastrointestinal, cardiovascular, respiratory, oncology, and
neuroscience products. AstraZeneca is listed in the Dow Jones
Sustainability Index (Global) as well as the FTSE4Good Index.
'ARIMIDEX', 'CASODEX', 'FASLODEX', 'NOLVADEX', 'ZOLADEX',
'TOMUDEX', and 'IRESSA' are trademarks, the property of the
AstraZeneca group of companies.
For further information, please visit our website
www.astrazenecapressoffice.com

Contact:

Lynn Grant, Senior Global PR Manager, AstraZeneca, Tel:
+44-(0)-1625-517-406, Email: lynn.grant@astrazeneca.com. Or: Sara
Singer, Shire Health International, Tel: +44-(0)-20-7108-6521, Email:
sara.singer@shirehealthinternational.com

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