Actualizado 07/12/2006 12:46
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A New Gold Standard in Early Breast Cancer as Arimidex(TM) (Anastrozole) Overtakes Tamoxifen

MACCLESFIELD, England, December 7 /PRNewswire/ --

-- More Patients Set to Benefit as Weight of Evidence for 'Arimidex' Prompts Wave of Change

-- For Health Professional and Consumer Press Only

-- FOR INTERNATIONAL JOURNALISTS - NOT FOR US MEDIA

Today, for the first time in over 20 years, a new gold standard treatment has emerged for postmenopausal women with early breast cancer. In the US, some European countries and Japan, tamoxifen has been surpassed by 'Arimidex' (anastrozole) as the most widely prescribed hormonal treatment for post-menopausal women newly diagnosed with the disease.

The news comes just days prior to the five-year anniversary of the first presentation of results of the landmark ATAC* trial(1), which many believe was the catalyst for the wave of treatment change now being seen. Prior to the ATAC trial, tamoxifen was widely considered the gold standard endocrine therapy in early breast cancer. However, following the initial results(2) and further updates from ATAC(3,4), which showed the superiority of 'Arimidex' over tamoxifen for both efficacy and tolerability, there has been a steady decrease in the numbers of patients receiving tamoxifen, with doctors favouring 'Arimidex' instead.

Tamoxifen has been widely credited with driving the dramatic improvements in survival rates in early breast cancer over the past 10-20 years, reducing the risk of recurrence by 50% compared with no hormonal treatment(5). Now experts expect to see even further improvements in the future due to the additional benefits conferred by 'Arimidex'.

"To my mind, this really does mark a new era in breast cancer treatment," said Professor Jeffrey Tobias, Professor of Cancer Medicine at University College London and one of the ATAC Steering Committee members. "Many cancer specialists have already recognised the additional benefits of anastrozole and have been prescribing it for some time, based on solid clinical evidence. It is now increasingly recognised as the optimal treatment option for many patients."

Following the initial announcement of early results from the ATAC trial in 2001(1), mounting evidence has demonstrated that 'Arimidex' offers women an increased chance of remaining cancer free compared with tamoxifen, coupled with fewer serious side effects. Over the past five years, key findings from ATAC have demonstrated 'Arimidex' is associated with substantial efficacy and tolerability benefits over and above those provided with tamoxifen, including(4,6):

-- 26% reduction in the risk of recurrence (HR = 0.74, p=0.0002)

-- 53% reduction in the risk of contralateral breast cancer (HR = 0.47, p=0.001)

-- 16% reduction in the risk of distant recurrence (HR = 0.84, p=0.06)

-- 13% reduction in the risk of breast cancer mortality (HR = 0.87, p=0.2)

-- A significantly reduced risk of endometrial cancer, DVT and stroke

Although there is an increased incidence of bone fracture and joint pain in patients receiving 'Arimidex', these events are considered predictable and manageable compared with the serious adverse events associated with tamoxifen(6,7).

The continuing clinical evidence from the ATAC trial, together with major peer-reviewed publications, recommendations in international and local guidelines and the assurance generated by what is now over two million years of patient experience, have all come together to generate this widespread change in clinical practice. The adoption of 'Arimidex' as a new gold standard is set to improve outcomes for patients worldwide, and demonstrates the importance of robust data in providing doctors with the confidence to change.

"High quality data are essential when evaluating current and new treatments. Through congresses, publications and guidelines, the communication routes are there to ensure that physicians are kept up to date with the latest advancements," added Dr Aman Buzdar of the MD Anderson Cancer Centre in Texas, and Chair of the ATAC Steering Committee. "The data have conclusively shown us that more women will stay cancer-free with 'Arimidex' and fewer will suffer serious side effects. The ultimate rewards are seen in the day-to-day consultations, with more positive conversations between physicians and their patients, who have a better chance of remaining recurrence free."

References

1. Baum M. The ATAC (Arimidex, Tamoxifen, Alone or in Combination) adjuvant breast cancer trial in postmenopausal (PM) women. Breast Cancer Res Treat 2001; 69 (3): 210, Abs 8.

2. ATAC Trialists' Group. Anastrozole alone or in combination with tamoxifen versus tamoxifen alone for adjuvant treatment of postmenopausal women with early breast cancer: first results of the ATAC randomised trial. Lancet 2002; 359 (9324): 2131-2139.

3. ATAC Trialists' Group. Anastrozole alone or in combination with tamoxifen versus tamoxifen alone for adjuvant treatment of postmenopausal women with early-stage breast cancer - Results of the ATAC (Arimidex, Tamoxifen Alone or in Combination) trial efficacy and safety update analyses. Cancer 2003; 98 (9):1802-1810.

4. ATAC Trialists' Group. Results of the ATAC (Arimidex, Tamoxifen, Alone or in Combination) trial after completion of five years' adjuvant treatment for breast cancer. Lancet 2005; 365 (9453): 60-62.

5. Early Breast Cancer Trialists' Collaborative Group. Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: an overview of the randomised trials. Lancet 2005; 365: 1687-1717.

6. 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; 7 (8): 633-643.

7. Perez EA. The balance between risks and benefits: Long-term use of aromatase inhibitors. Eur J Cancer Supplements 2006; S4: 16-25.

For further information, or to view an educational module on how 'Arimidex' data have influenced prescribing in early breast cancer to create a new gold standard, please visit our website www.astrazenecapressoffice.com

Notes to Editors

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

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 property of the AstraZeneca group of companies.

Lynn Grant, Global PR Director, Oncology, AstraZeneca, Direct Line: +44-(0)-1625-517-406, Mob: +44-(0)-7715-484-917, Email: Lynn.Grant@Astrazeneca.com. Fiona Robertson, Account Director, Shire Health, Mob: +44-(0)-781-241-4434, Email: fiona.robertson@shirehealth.com

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