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De: PR Newswire
Brasil
Para: THERESA CATHARINA DE GÓES CAMPOS
Assunto: Time for Change - Aromatase Inhibitors
Such as ARIMIDEX(TM) Confirmed Superior to
tamoxifen
01 de agosto de 2006 07:51 HORALOCAL
Time for Change - Aromatase Inhibitors Such as
ARIMIDEX(TM)
Confirmed Superior to tamoxifen
International Panel of Breast Cancer Specialists
Agree: 'With
Successful Adjuvant Therapy, Early Breast Cancer
is Potentially a
Curable Condition.'
MACCLESFIELD, England, Aug. 1 /PRNewswire/ --
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.
-- AIs 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 .
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
$23.95 billion and leading positions in sales of
gastrointestinal,
cardiovascular, neuroscience, respiratory,
oncology and infection
products. AstraZeneca is listed in the Dow Jones
Sustainability Index
(Global) as well as the FTSE4Good Index.
'ARIMIDEX' is a trademark, the properties of the
AstraZeneca group of
companies.
For further information, please visit our
website
http://www.astrazenecapressoffice.com
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
SOURCE AstraZeneca
08/01/2006
CONTACT: Lynn Grant, Global PR Director,
Oncology, of AstraZeneca,
Direct Line, +44-0-1625-517-406, or Mobile
+44-0-7715-484-917, or
Lynn.Grant@Astrazeneca.com; or Sara Singer of
Shire Health
International, Direct Line +44-0-20-7108-6521,
or Mobile
+44-0-7881-810-328, or
sara.singer@shirehealthinternational.com
Web site: http://www.astrazenecapressoffice.com
http://www.cmrojournal.com
http://oncology.thelancet.com
BNED: NG
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BRASIL-NÉLIA GARCIA
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