Time for Change - Aromatase Inhibitors Such as ARIMIDEX(TM) Confirmed Superior to tamoxifen

Macclesfield, England (ots/PRNewswire) -

- International Panel of Breast Cancer Specialists Agree: 'With
Successful Adjuvant Therapy, Early Breast Cancer is Potentially a
Curable Condition.'

- ATTN: Health Professional Press

- For International Journalists - Not for US Media

Today, leading breast cancer experts advised unequivocally that 5
years' tamoxifen, for so long regarded as the 'gold standard'
hormonal breast cancer therapy, is no longer the most effective
treatment option for postmenopausal women with early,
hormone-sensitive breast cancer. This global consensus was published
today in Current Medical Research and Opinion and advises doctors
that they should be prescribing aromatase inhibitors (AIs), such as
ARIMIDEX(TM) (anastrozole), to prevent recurrence and ultimately
reduce mortality. The International Aromatase Inhibitor Expert Panel,
which included 24 leading breast cancer clinicians from Europe, the
USA, Australia, China and Brazil, agreed that with successful
post-surgery treatment, patients with early breast cancer can
potentially be cured of their condition and that AIs, such as
anastrozole, should be prescribed as the preferred therapy(1).

"Over the last three years, there has been an influx of new
information about the use of aromatase inhibitors in early breast
cancer, and while this is great news, it has created a great deal of
confusion. Physicians have been looking for clear guidance on whether
it is better for our patients to move on from tamoxifen in favour of
an AI. The guidance from an elite group of breast cancer experts
published today, helps to clarify how best to use AIs in everyday
practice. We can now be confident that to provide the best care for
our patients, we should be using an aromatase inhibitor at the
earliest opportunity," commented Dr. Aman Buzdar of the MD Anderson
Cancer Centre, Texas, and a member of the Panel.

The global consensus document provides vital guidance for
clinicians who are faced with making crucial treatment decisions on
behalf of their patients on a daily basis. The Panel reviewed data
from all the major early breast cancer AI treatment trials with the
aim of providing a 'rational interpretation of the impact of these
data on current practice'. The overarching conclusion of the paper is
not only that patients newly diagnosed with hormone-sensitive early
breast cancer should receive an AI following initial surgery but that
women who are already taking tamoxifen, should consider changing
their treatment to an AI(1).

Evidence-based recommendations

In the consensus statement published today, the Panel made several
evidence based-recommendations. A summary of the Panel's topline
findings are below:(1)

- AIs are superior to tamoxifen and are, therefore, the treatment
of choice in postmenopausal women with hormone-sensitive, early
breast cancer. In newly diagnosed patients, AIs are considered the
preferred therapy, and patients already receiving tamoxifen should
consider switching to an AI.

- Although 5 years' tamoxifen has been the standard of care for 20
years, and remains an effective treatment for certain patients, there
is no subgroup of patients who would not benefit from initial AI
adjuvant therapy.

- Reported gynaecological adverse events are substantially reduced
with AIs compared with tamoxifen. The majority of gynaecological
adverse events with tamoxifen occur during the first 2.5 years of
treatment, and cause a burden to the patient that may affect
compliance with therapy.

- Risks associated with tamoxifen treatment, namely deep vein
thrombosis, stroke and endometrial cancer, cannot be monitored for
nor predicted in individual patients. This is a crucial difference
between the management of patients receiving adjuvant therapy with
tamoxifen or AIs. By prescribing an AI, physicians can be confident
that they are giving their patients the best opportunity to stay
cancer free for longer, without the risk of potentially
life-threatening side effects.

- Als are associated with increased risk of osteoporotic fracture
compared with tamoxifen, however current data confirms bone problems
with AIs are predictable and appear to be manageable.

The consensus paper coincides with the publication of mature data
from the landmark ATAC* trial in the Lancet Oncology(2). Anastrozole
is the only AI with mature safety and tolerability data, as well as
a favourable risk:benefit profile compared to tamoxifen, for the full
5-year treatment period. The results further support the Panel's
findings and add to the evidence base for AIs, specifically
anastrozole, as the preferred treatment for postmenopausal women with
hormone-sensitive early breast cancer.

"Although tamoxifen has served us well for over 20 years, if we
want to give our patients the most effective and well tolerated
treatment for their breast cancer, it's time to consider an AI,"
explained Professor Rowan Chlebowski, of the Harbor-UCLA Medical
Centre, California, and a member of the Panel. "The data in support
of AIs, and for anastrozole in particular, is overwhelming and
there's no doubt that tamoxifen is no longer the gold standard
treatment for these women."

The full consensus paper can be accessed via the Current Medical
Research and Opinion website: http://www.cmrojournal.com. In
addition, the publication of the mature data from the ATAC trial is
available on the Lancet Oncology website:
http://oncology.thelancet.com.

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'Arimidex' is a trademark, the properties of the AstraZeneca group
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Notes to Editors:

* ATAC - 'Arimidex', Tamoxifen, Alone or in Combination

Over the past few years, many studies have been published
concerning the relative efficacy and safety profiles of tamoxifen and
the aromatase inhibitors as adjuvant therapy for postmenopausal women
with early hormone receptor-positive breast cancer. Recently, debate
has centred around trials which have studied tamoxifen versus AIs as
initial adjuvant therapy, switching and sequencing strategies, and
extended adjuvant therapy.

In December 2005, a group of 24 breast cancer experts from the
USA, UK, France, Germany, Spain, Italy, Australia, Belgium, Sweden,
China and Brazil, met to review efficacy and safety data from the
recent major trials investigating tamoxifen and the third-generation
AIs in postmenopausal women which have challenged the perception of
tamoxifen as optimum adjuvant endocrine therapy. Data from the
ATAC(3), BIG 1-98(4), MA.17(5), IES(6), ITA(7), ABCSG Trial 8(8) and
ARNO 95(8) trials were considered to provide a rational
interpretation of the impact of these data on current practice and to
highlight areas where further investigation is needed.

References:

1. Buzdar A, Chlebowski R, Cuzick J et al. Defining the role of
aromatase inhibitors in the adjuvant endocrine treatment of early
breast cancer. Curr Med Res Opin 2006;22(8):1575-85

2. The ATAC Trialists' Group. Comprehensive side-effect profile of
anastrozole and tamoxifen as adjuvant treatment for early-stage
breast cancer: long-term safety analysis of the ATAC trial.
http://oncology.thelancet.com. Published online 19 July, 2006

3. 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;365:60-2

4. Thurlimann B, Keshaviah A, Coates A, et al. A comparison of
letrozole and tamoxifen in postmenopausal women with early breast
cancer. N Engl J Med 2005;353:2747-57

5. Goss PE, Ingle JN, Martino S, et al. A randomized trial of
letrozole in postmenopausal women after five years of tamoxifen
therapy for early-stage breast cancer. N Engl J Med 2003;349:1793-802

6. Coombes RC, Hall E, Gibson LJ, et al. A randomized
trial of exemestane after two to three years of tamoxifen therapy in
postmenopausal women with primary breast cancer. N Engl J Med
2004;350:1081-92

7. Boccardo F, Rubagotti A, Puntoni M, 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;23:5138-47Jakesz R, Samonigg H, Greil R et
al. Extended adjuvant treatment with anastrozole: results from the
Austrian Breast and Colorectal Cancer Study Group Trial 6a
(ABCSG-6a). J Clin Oncol (Meeting Abstracts) 2005;23:10s, abs 527

8. 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

ots Originaltext: AstraZeneca
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