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Women With Early Breast Cancer are More Likely to Remain Cancer Free by Changing Treatment From Tamoxifen to Arimidex(TM) (Anastrozole)

Macclesfield, England, November 17 (ots/PRNewswire)

FOR INTERNATIONAL JOURNALISTS - NOT FOR US MEDIA
- Data Published in the Lancet Oncology Report That Patients are
More Likely to Live Cancer Free for Longer if Tamoxifen is Replaced
With ARIMIDEXT(TM)
According to data published today in the Lancet Oncology, women
with early breast cancer, who have their treatment swapped from
tamoxifen to ARIMIDEX(TM) (anastrozole) at 2-3 years, have a better
chance of living cancer free for longer than if they continue taking
tamoxifen[1]. The data  are from a meta-analysis of three key
international trials[2,3,4] and confirm  that, in postmenopausal
women with hormone-sensitive disease, replacing  tamoxifen with
anastrozole can almost halve the likelihood of disease  recurrence.
Furthermore, with survival being the ultimate goal, changing
treatments can reduce the risk of death by nearly a third.
Commenting on these data, lead author of the meta-analysis,
Professor Walter Jonat of the University of Kiel, Germany said,
"These data will be welcome news to the many thousands of women
around the world who are currently taking tamoxifen to help prevent
the recurrence of early breast cancer. By changing treatment, their
chances of beating the disease and living longer cancer free can be
greatly improved, giving them more confidence for the future."
The three trials in the meta-analysis were similarly designed to
assess, in women already being treated with tamoxifen, whether or not
replacing tamoxifen with anastrozole after 2-3 years was more
effective than continuing to take tamoxifen for the full 5-year
treatment period. The combined data show, at a median follow-up of 30
months, that replacing tamoxifen with anastrozole can significantly
reduce recurrence, prevent metastatic spread and ultimately save the
lives of many women with early breast cancer.
Women who changed to anastrozole, rather than remaining on
tamoxifen, experienced a;
  • 29% improvement in overall survival (HR 0.71; 95% CI 0.52 - 0.98; p=0.0377), i.e. the risk of dying was reduced by almost a third
  • 45% improvement in event-free survival (HR 0.55; 95% CI 0.42 - 0.71; p<0.0001), i.e. the risk of the disease returning was reduced by almost half and
  • 39% improvement in distant recurrence-free survival (HR 0.61; 95% CI 0.45 - 0.83; p=0.0015)[1].
Getting it right from the start.
Although these data are a valuable finding for women already
taking tamoxifen for the treatment of hormone-sensitive, early breast
cancer, it is important to remember that the findings do not apply to
women newly diagnosed with the disease. For these patients, recent
evidence and opinion show the importance of using anastrozole rather
than tamoxifen right from the start[5-7]. There are currently no data
demonstrating any benefit of a  planned sequencing strategy of two
therapies over 5 years of tamoxifen alone  in patients with early
breast cancer.
"The landmark ATAC trial established that starting treatment with
anastrozole at the earliest opportunity after surgery, and giving it
for the full 5 years of treatment, is not only more effective than
tamoxifen for the prevention of disease recurrence but better
tolerated as well. This would suggest that the best place to use
anastrozole is right from the start. The important data published in
the Lancet Oncology today demonstrate that patients who have not had
the benefit of starting treatment on anastrozole, can still gain from
the significant benefits of anastrozole, by switching at 2 years,"
stated Prof. Jeffrey Tobias of University College Hospital, London,
United Kingdom.
Anastrozole was granted a new licence indication in Europe in July
2006, confirming its approval for use following 2-3 years of
tamoxifen therapy. This approval was granted on the basis of the
disease-free survival benefit for anastrozole demonstrated in the
three individual trials included in the meta-analysis. Anastrozole is
now the first and only aromatase inhibitor to be approved both for
primary adjuvant use and following 2-3 years' treatment with
tamoxifen.
References
1. Jonat W, Gnant M, Boccardo F et al. Effectiveness of switching
from adjuvant tamoxifen to anastrozole in postmenopausal women with
hormone-sensitive early-stage breast cancer: a meta-analysis. Lancet
Oncology. Published online November 17, 2006
DOI:10.1016/S1470-2045(06 )70948-2
2. Jakesz, R. et al. The benefits of sequencing adjuvant tamoxifen
and anastrozole in postmenopausal women with hormone-responsive early
breast cancer: 5 year-analysis of ABCSG Trial 8. Abstract No. 13. San
Antonio Breast Cancer Symposium 2005
3. 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 (9484):455-462
4. Boccardo F, Rubagotti A, Puntoni Met al. Switching to
anastrozole versus continued tamoxifen treatment of early breast
cancer: Preliminary results of the Italian Tamoxifen Anastrozole
trial. Journal of Clinical Oncology 2005; 23 (22):5138-5147
5. 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 Jan
1-7;365(9453):60-62
6. 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
7. 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. Lancet
Oncology. 2006 Aug;7(8):633-43
For further information, please contact:
    Lynn Grant - AstraZeneca
    Global PR Director - Oncology
    Direct Line: +44-(0)-1625-517-406
    Email:  Lynn.Grant@Astrazeneca.com
    Elly Brookes - Shire Health International
    Direct Line: +44 (0) 20-7108-6533
    Email:  elly.brookes@shirehealthinternational.com
Notes to Editors
Meta-analysis includes:
ABCSG - Austrian Breast & Colorectal Cancer Study Group,
ARNO - 'Arimidex' - 'Nolvadex',
ITA - Italian Tamoxifen Anastrozole
ATAC - 'Arimidex', Tamoxifen, Alone or in Combination
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.
'ARIMIDEX', 'CASODEX', 'FASLODEX', 'NOLVADEX', 'ZOLADEX',
'TOMUDEX', and 'IRESSA' are trademarks, the property of the
AstraZeneca group of companies.
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.
For more information, please visit www.astrazenecapressoffice.com

Contact:

For further information, please contact: Lynn Grant - AstraZeneca,
Global PR Director - Oncology, Direct Line: +44-(0)-1625-517-406.
Email: Lynn.Grant@Astrazeneca.com. Elly Brookes - Shire Health
International, Direct Line: +44 (0) 20-7108-6533, Email:
elly.brookes@shirehealthinternational.com

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