'ZOLADEX' AS EFFECTIVE AS 'STANDARD' CHEMOTHERAPY IN EARLY BREAST CANCER

Results from the ZEBRA^* study, released today, show that treatment with 'Zoladex' is as effective as 'standard' chemotherapy ^** for pre/perimenopausal women with hormone-sensitive, node-positive early breast cancer. For these women, chemotherapy is currently the accepted 'standard' treatment approach following initial surgery. However, chemotherapy is frequently associated with potentially harrowing side effects including hair loss, severe nausea and vomiting, and the risk of life-threatening infection. In the ZEBRA study, 'Zoladex' was not associated with these distressing side effects.

'Zoladex' is already approved for the treatment of early breast cancer in a number of countries including Germany, Italy and Japan. The new data will be submitted to other regulatory authorities world-wide, including the USA, with the aim of allowing doctors in other countries to prescribe 'Zoladex' for early breast cancer. Currently 'Zoladex' goserelin is available and widely-used throughout the world for the treatment of advanced breast cancer.

ZEBRA is the largest ever study comparing hormonal therapy with 'standard'chemotherapy. The study involved 1,640 pre and perimenopausal women with early breast cancer randomised to receive either 'Zoladex' (3.6 mg every 28 days for 2 years) (n= 817) or 6 x 28 day cycles of 'standard'chemotherapy (n= 823). Primary end points were disease-free and overall survival and tolerability.

In the hormone-sensitive group of patients (73%), 'Zoladex' was shown to be equivalent to 'standard'chemotherapy in terms of disease-free survival (HR=1.01, 95% CI 0.84-1.20). In addition, 'Zoladex' was not associated with the distressing and debilitating side effects routinely observed with chemotherapy. The incidence of typical side effects of chemotherapy e.g. alopecia, nausea and vomiting (despite use of anti-emetics in over 97% of chemotherapy patients ) and infection were all substantially higher in the chemotherapy group compared to the 'Zoladex'-treated patients (43% vs. 4%, 56% vs. 5% and 13% vs. 5%, respectively).

Both treatments were associated with menopausal symptoms, such as vaginal dryness and hot flushes. However, while the incidence of menopausal symptoms was initially lower in the chemotherapy treated group, (vaginal dryness: 14% vs. 24% ; hot flushes: 42% vs. 72%, respectively), these remained virtually unchanged post-treatment, while on cessation of 'Zoladex' treatment, the incidence of these effects fell to below that experienced by the chemotherapy group (vaginal dryness: 12% vs. 9%; hot flushes: 37% vs. 17%, respectively).

Dr George Blackledge, Medical Director of Oncology at AstraZeneca, commented today "ZEBRA is the largest study directly comparing hormonal therapy with chemotherapy ever undertaken and highlights the important research contribution that AstraZeneca makes to the field of breast cancer treatment. An estimated 3 in every 5 breast cancers occurring in pre/perimenopausal women are hormone sensitive. The ZEBRA study results indicate that for these women, 'Zoladex' could offer an equally effective, yet better tolerated, alternative to chemotherapy following initial surgery for early breast cancer.”

Visit www.BrCaWatch.com for more information about hormonal therapy and breast cancer

Further enquires to:

Media Steve Brown +44 (0)20 7304 5033 Lucy Williams +44 (0)20 7304 5034

Note to News Editors:

The term 'hormone-sensitive'for women in this study means ER+ve. In ER -ve patients, chemotherapy remains the adjuvant treatment of choice. The ZEBRA study involved 1,640 pre-/perimenopausal women aged £ 50 years with stage II node-positive breast cancer. This is the first study to directly compare the benefits of oestrogen suppression with an LHRH agonist with a 'standard'chemotherapy regimen following initial surgery (+ radiotherapy). Patients received either 'Zoladex' (3.6mg every 28 days) for 2 years or chemotherapy with cyclophosphamide, methotrexate and 5-fluorouracil (CMF) 6 x 28 day cycles. ZEBRA is part of a larger programme studying the role of 'Zoladex'in the treatment of early breast cancer involving over 8,500 patients to date.

*'Zoladex' in Early Breast Cancer Research Association Trial

**Standard chemotherapy in the ZEBRA trial was cyclophosphamide, methotrexate and 5-fluorouracil (CMF)



Zoladex is a trademark, property of the AstraZeneca group of companies.