AstraZeneca

Summary of Key 'Arimidex' (Anastrozole) Data From the 27th Annual San Antonio Breast Cancer Conference

    San Antonio, Texas (ots/PRNewswire) -

    - New Trial Results Offer More Choice for More Women With Breast Cancer

    The ATAC ('Arimidex', Tamoxifen, Alone or in Combination) Completed Treatment Analysis(1),(2): Presented by Professor Anthony Howell and simultaneously published via fast-track peer-review in The Lancet

    The latest data from the ATAC Trial reveal that anastrozole is the first drug in 30 years to be proven to be more effective than tamoxifen in preventing the return of the disease, in postmenopausal women with hormone-sensitive, early breast cancer. As a result, these compelling data are expected to change current clinical practice. Specifically, the results showed that 5 years of adjuvant anastrozole therapy provides the following benefits, over and above those offered by tamoxifen:

    - a 26% further reduction in the risk of recurrence (HR =0.74; p= <0.002)

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

    - a 16% further reduction in the risk of distant recurrence (HR = 0.84; p= 0.06)(i)

    For further information, please go to www.ATAC-news.com

    Combined analysis of the ABCSG 8 Trial and the German ARNO 95 Trial(3): Presented by Professor Raimund Jakesz

    The ABCSG and ARNO trials were designed to assess, in patients who had already started a course of adjuvant treatment with tamoxifen, whether changing therapy to anastrozole after 2 years is more effective than continuing treatment with tamoxifen.

    The results from the combined analysis of these trials have shown that, by changing their therapy to anastrozole after 2 years of tamoxifen women have a 40% lower risk of their cancer returning than if they remain on tamoxifen treatment.

    Commenting on these results, Professor Jakesz, of the Vienna Medical School, Austria, said: "What we have seen here is that women who change their therapy to anastrozole have a significantly lower risk of their cancer returning than if they continue to take tamoxifen. This is great news for the thousands of breast cancer patients who have already started their adjuvant therapy with tamoxifen, as it means that they can also benefit from the efficacy and tolerability advantages that anastrozole offers over tamoxifen.

    In his presentation at the conference Professor Jakesz concluded that in order to lower the risk of recurrence, postmenopausal women who are currently on adjuvant tamoxifen should be switched to anastrozole after 2 years of treatment.

    For further information, please go to www.astrazenecapressoffice.com

    Additional data suggest benefits for even more women

    A further set of data(4) was presented for the first time this week in San Antonio, which gave an early indication of the potential of using anastrozole in younger women. By using anastrozole in conjunction with another hormonal treatment 'Zoladex' (goserelin), which acts by temporarily inducing the menopause, women appear to benefit from the combined efficacy of the two drugs. Although using the two drugs in this way has so far only been tested in a small number of patients, the results from the trial suggest that goserelin plus anastrozole may be an effective therapy for younger women with advanced-stage breast cancer. This is particularly important as it increases the range of treatment options, other than chemotherapy, available for these women

    Anastrozole and goserelin were both developed by AstraZeneca, a company that is leading the way in producing innovative new treatment options for breast cancer. Commenting on the data presented this week, Bernie Tyrrell, Vice President of Oncology for AstraZeneca said: "The San Antonio conference this year has seen the presentation of an array of important and, in some cases, practice-changing new data for AstraZeneca breast cancer treatments. These data move us even closer to our goal of providing a full range of effective and well-tolerated therapies, that can be used to treat women of any age, and at any stage of the disease, providing more choices for more women."

    References

    1. Howell A, on behalf of the ATAC Trialists' Group. The ATAC ('Arimidex', Tamoxifen, Alone or in Combination) trial in postmenopausal women with early breast cancer - updated efficacy results based on a median follow-up of 5 years. Abstract No. 1, San Antonio Breast Cancer Symposium 2004.

    2. The ATAC Trialists' Group. Results Of The ATAC ('Arimidex', Tamoxifen, Alone Or In Combination) Trial After Completion Of 5 Years' Adjuvant Treatment For Breast Cancer. Available on line at www.thelancet.com

    3. Jakesz R, et al. Benefits of switching postmenopausal women with hormone-sensitive early breast cancer to anastrozole after 2 years adjuvant tamoxifen: combined results from the 3,123 women enrolled in the ABCSG Trial 8 and ARNO 95 Trial. Abstract No. 2, San Antonio Breast Cancer Symposium 2004.

    4. Carlson R et al, Goserelin plus anastrozole for the treatment of premenopausal women with hormone receptor-positive, metastatic breast cancer. Abstract no 6052 San Antonio Breast Cancer Symposium 2004.

    Further information

    (i) In the trial population as a whole (the intent to treat, ITT population), the hazard ratio (HR) for distant recurrence was 0.86, p = 0.04 - i.e. the value has reached statistical significance in favour of 'Arimidex'. In the hormone-sensitive population (84% of the total population), patients have a better prognosis and therefore too few events have so far occurred to show significance (p=0.06). As expected though, the HR for distant recurrence is actually more favourable in hormone-sensitive patients (0.84) and this difference is fully expected to become significant with time.

    AstraZeneca continues its tradition of research excellence and innovation in oncology that led to the development of its current anti-cancer therapies including ARIMIDEX(TM) (anastrozole), CASODEX(TM) (bicalutamide), FASLODEX(TM) (fulvestrant), NOLVADEX(TM) (tamoxifen), ZOLADEX(TM) (goserelin), TOMUDEX(TM) (raltitrexed) and IRESSA(TM) (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.

    Since AstraZeneca released its first anti-cancer drug, 'Nolvadex' (tamoxifen), more than 25 years ago, investment in research has led to the discovery of new anti-cancer agents and other innovative therapeutic strategies which give AstraZeneca an extensive portfolio of developmental agents to complement the established product range. AstraZeneca's product range for breast cancer include the following:

    - 1973: Tamoxifen (NOLVADEX(TM)): a well-tolerated, oral anti-oestrogen. Now the most widely prescribed agent for the treatment of all stages of breast cancer worldwide.

    - 1990: Goserelin (ZOLADEX(TM)): a well-tolerated and widely-prescribed LHRH analogue, administered by sub-cutaneous injection every 28 days, which reduces sex hormone production. Goserelin is now used in the treatment of early and advanced breast cancer in pre-menopausal women with hormone-sensitive disease.

    - 1995: Anastrozole (ARIMIDEX(TM)): the first of a new class of drugs - selective 'aromatase inhibitors' - now widely used in the treatment of early and advanced breast cancer in post-menopausal women with hormone sensitive disease. Anastrozole is approved world-wide for postmenopausal women with advanced disease and as an adjuvant treatment for postmenopausal women with hormone receptor-positive early breast cancer in over 79 countries including the US, UK, Germany, Italy, Spain.

    - 2002: Fulvestrant (FASLODEX(TM)): a new type of breast cancer therapy (an oestrogen receptor antagonist without known agonist effects). 'Faslodex' is now approved in the European Union for the treatment of postmenopausal women with receptor-positive locally advanced or metastatic breast cancer, for disease relapse or progression on or after therapy with an anti-oestrogen such as tamoxifen. 'Faslodex' has been launched in the USA since May 2002 and more recently received regulatory approval throughout the 25 members countries in the European Union in March 2004.

    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 $18.8 billion and leading positions in sales of gastrointestinal, oncology, cardiovascular, neuroscience and respiratory products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index.

    For further information, including webcasts of the data presentations referred to above, please visit www.astrazenecapressoffice.com

    WEBCASTS OF KEY DATA PRESENTATIONS: www.astrazenecapressoffice.com

ots Originaltext: AstraZeneca
Im Internet recherchierbar: http://www.newsaktuell.ch

Contact:
Contact: Alison Wright, Global PR Manager, Oncology, AstraZeneca,
Tel: +44(0)1625-230-076 Mobile: +44(0)7879-487-331 Email:
Alison.K.Wright@astrazeneca.com



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