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New Data Show Survival Benefit for Arimidex(TM) in Early Breast Cancer

Macclesfield, England (ots/PRNewswire)

- Replacing tamoxifen With Arimidex (TM) (anastrozole) Shown to
Reduce Patient's Risk of Death by Nearly a Third
Breakthrough new data presented today show breast cancer treatment
'Arimidex' (anastrozole) is the first aromatase inhibitor (AI) to
provide an overall survival benefit, compared with tamoxifen, in the
treatment of hormone-sensitive early breast cancer.(1)
According to a new analysis of data presented at a leading breast
cancer symposium in San Antonio, Texas (SABCS)(i), by replacing
tamoxifen with anastrozole, postmenopausal women being treated for
early breast cancer are not only able to almost halve the likelihood
of their disease returning, but more importantly, reduce their risk
of dying by nearly a third.
"For the first time, an aromatase inhibitor has shown a survival
advantage over tamoxifen in early breast cancer. These studies, along
with others such as the ATAC trial, confirm that tamoxifen is no
longer the best option we can offer our patients. Women who have
taken 2 years of tamoxifen should be switched to anastrozole at the
earliest opportunity to give them the best chance of surviving their
disease," commented Prof. Walter Jonat of University of Kiel,
Germany, the key investigator who presented the new data at the
SABCS.
Three key international trials [ABCSG 8 (n = 2262)(2,3), ARNO 95
(n = 962)(3), and ITA(4) (n = 448)](ii) were similarly designed to
assess, in women already being treated with tamoxifen, whether or not
replacing tamoxifen therapy with anastrozole after 2 years was more
effective than remaining on tamoxifen for the full 5-year treatment
period. Dr Jonat presented a meta-analysis of these three trials
(n=4006) at the SABCS today. The data showed, at a median follow-up
of 30 months, patients who started taking 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),
  • 45% improvement in event-free survival (HR 0.55; 95% CI 0.42 - 0.71; p<0.0001), and
  • 39% improvement in distant recurrence-free survival (HR 0.61; 95% CI 0.45 - 0.83; p=0.0015).(1)
(Event-free survival: any disease recurrence - local,
contralateral or distant; Distant recurrence free survival: distant
recurrence only)
These data now confirm that replacing tamoxifen with anastrozole
can significantly reduce recurrence, prevent metastatic spread and
ultimately save the lives of many women with early breast cancer.
"These survival data are good news. Year after year we continue to
hear breakthroughs for hormonal therapies. Today's data bring us that
much closer to hearing the words we really want to hear - that for
some, survival is a greater possibility than ever before," stated
Dallas Petroff, Executive Director of the Willow Breast Cancer
Support & Resource Services in Canada.
Today's data are exciting news for the millions of women currently
taking tamoxifen to prevent disease recurrence. However, it is
important to remember that recent evidence and opinion have shown
that women newly diagnosed with hormone-sensitive early breast cancer
should be started on anastrozole as the initial hormonal treatment
after surgery.(5) In the landmark ATAC(ii) trial (n=9366), women
taking anastrozole for the full 5-year treatment period had a
significantly reduced risk of disease recurrence (including distant
disease recurrence and contralateral breast cancer), compared with
tamoxifen, especially during the first 3 years following surgery,
when this risk is greatest.(5) Additionally, these women suffered far
fewer serious side-effects, including an increased risk of
endometrial cancer, thromboembolic events and ischaemic
cerebrovascular events, than those who were started on tamoxifen(5).
Although anastrozole, like all AIs, increases the risk of
osteoporotic fracture compared with tamoxifen, it is possible to
predict which women may be most at risk of fracture and manage them
accordingly. This is not the case with the more serious side effects
associated with tamoxifen.
"The ATAC trial has confirmed that starting treatment with
anastrozole at the earliest opportunity after surgery, and giving it
for the full 5 years of treatment, is more effective than tamoxifen
for the prevention of disease recurrence. This would suggest that the
best place to use anastrozole is right from the start. These new data
are important news for women currently taking tamoxifen who can still
gain from the significant benefits of anastrozole by switching at 2
years." commented Prof. Jeffrey Tobias of University College
Hospital, London, United Kingdom.
References
1. Jonat W et al. Switching from adjuvant tamoxifen to anastrozole
in postmenopausal women with hormone-responsive early breast cancer:
a meta-analysis of the ARNO 95 trial, ABCSG Trial 8, and the ITA
trial. Abstract No. 18. San Antonio Breast Cancer Symposium 2005.
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, 365 (9453):
60-62.
Notes to Editors
(i) SABCS - San Antonio Breast Cancer Symposium
(ii) ABCSG - Austrian Breast & Colorectal Cancer Study Group,
ARNO - 'Arimidex' - 'Nolvadex',
ITA - Italian Tamoxifen Anastrozole
(iii) ATAC - 'Arimidex', Tamoxifen, Alone or in Combination
In the UK, 'Arimidex' (anastrozole) is licensed for the adjuvant
treatment of postmenopausal women with hormone receptor positive
early invasive or advanced breast cancer
AstraZeneca 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 over US$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.
For more information and to view a webcast of the press conference
in San Antonio, please visit www.astrazenecapressoffice.com. To
preview and request broadcast footage, please log onto
www.thenewsmarket.com/astrazeneca

Contact:

Lynn Grant - AstraZeneca, Global PR Director, Direct Line:
+44-1625-517-406, Mobile: +44-7715-484917, Email:
Lynn.Grant@Astrazeneca.com. Anne-Marie Rodriguez, Shire Health
International, Mobile: +44-7765-848791, Email:
amr@shirehealthinternational.com

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