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

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

August 01, 2006

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

    MACCLESFIELD, England, Aug. 1 /Xinhua-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 .

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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

    For more information, please contact:

     Lynn Grant, Global PR Director, 
     Oncology, AstraZeneca, 
     Tel:    [phone]
     Mobile: [phone]
     Email:  [e-mail]

     Sara Singer,
     Shire Health International
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     Mobile: [phone]
     Email:  [e-mail]

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