NEW RESULTS FROM ONE OF THE WORLD'S LARGEST BREAST CANCER TRIALS HERALD HOPE FOR THOUSANDS OF WOMEN

"The greatest fear for women who have been treated for early breast cancer is to have their cancer return, which ultimately means their disease is incurable. However, these new data show that with anastrozole, women have the best possible chance yet to live cancer-free - even after their treatment has finished."

Professor Lesley Fallowfield, Director, Cancer Research UK Psychosocial Oncology Group, University of Sussex, UK

San Antonio, USA, Friday 14 December 2007/PR NEWSWIRE—New data from ATAC*, one of the world's largest and longest-running studies in postmenopausal women with early breast cancer, reinforce that anastrozole can help many more women live cancer-free, for longer. For the first time, anastrozole has been shown to be the only treatment of its type to be increasingly better than tamoxifen in preventing tumours from returning.^1,2 If cancer returns, women are much more likely to die - therefore, preventing breast cancer from returning ("recurrence") is key to saving lives.

The landmark results - presented today at the prestigious annual San Antonio Breast Cancer Symposium (SABCS), USA and also published online in The Lancet Oncology - show that even four years after a woman's treatment ends, the protective effect of anastrozole in reducing the risk of hormone-sensitive early breast cancer from returning continues to increase. Overall, women in the ATAC trial taking anastrozole were 24% less likely to have their cancer come back, compared with those taking tamoxifen.^1,2 This demonstrates the long-term impact of treatment decisions made at diagnosis and confirms the importance of starting treatment with anastrozole to help more women beat this devastating disease. Breast cancer currently affects 1.1 million women worldwide per year ³ and hormone-sensitive early disease accounts for around 75% of all cases of breast cancer in postmenopausal women.⁴

Presenting the data at SABCS, Professor John Forbes, Newcastle Mater Misericordiae Hospital, Australia commented: "Preventing recurrence is the primary goal in breast cancer management. If we can stop the cancer from returning, we can save more lives, more often. These exciting long-term follow-up data show that anastrozole is a more effective treatment option than tamoxifen for postmenopausal women with hormone-sensitive early stage disease - thus it is imperative these women get the most effective treatment at the earliest opportunity after diagnosis."

Professor Forbes continued: "Prior to the ATAC trial, tamoxifen was the standard of care for women with hormone-sensitive disease, with substantial evidence to support its crucial place in practice. However, these new 100-month data from ATAC show us that compared with tamoxifen, anastrozole can significantly reduce the risk of recurrence and minimise life-threatening side effects. Most encouragingly, the data also show us that the protective effect of anastrozole lasts well beyond the standard treatment period of five years and in my opinion confirms there is no longer any rationale for prescribing tamoxifen."

A recent global survey showed that over 70% of physicians believe that telling a patient her breast cancer has come back is worse than giving a diagnosis of early breast cancer.⁶ Recurrence, in the same breast, in the opposite breast or at a distant tumour site means that the cancer is more likely to be incurable and the patient is at risk of a bad outcome. It is therefore essential for both patients and their physicians** to know they are on a better therapy than tamoxifen to prevent the disease returning.

The impact of treatment on quality of life is also an important consideration in early breast cancer, and data have shown that the clinical benefits of anastrozole are achieved without adversely affecting the quality of patients' lives.⁵

"The ATAC 100-month data confirm that anastrozole is now the gold standard treatment for post-menopausal women with hormone-sensitive early breast cancer, irrespective of their recurrence risk, and is set to improve the outcomes of patients worldwide," commented Professor Anthony Howell, Christie Hospital, UK.

ATAC 100-month results summary:

After a median follow-up of over 8 years (100 months), compared with tamoxifen, anastrozole significantly:^1,2
- reduces the risk of all recurrences by 24% (HR 0.76 [0.67-0.87]; p=0.0001)
- improves disease free survival by 15% (HR 0.85 [0.76-0.94]; p=0.003)
- reduces the risk of distant metastases (recurrence elsewhere in the body) by 16% (HR 0.84 [0.72-0.97]; p=0.022)
- reduces the incidence of contralateral breast cancer (cancer in the opposite breast) by 40% (OR 0.60 [0.42-0.85]; p=0.004)
Prescribing anastrozole from the start means fewer patients have to be told the devastating news that their breast cancer has recurred.^1,2

Notes to Editors

For more information, to view a presentation of the ATAC 100 data by Professor John Forbes or to download the ATAC 100 publication in The Lancet Oncology, please visit www.ATAC100.com

The study will be published early online (00.01GMT Saturday15 December) and in the January edition of The Lancet Oncology.

*: ATAC: Arimidex, Tamoxifen, Alone or in Combination
**: Physicians: medical oncologists, gynaecologists and breast cancer surgeons
: Patients: postmenopausal women diagnosed with early breast cancer in the past five years and who had undergone breast cancer surgery

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'More Positive Conversations' global survey

The 'More Positive Conversations' survey was conducted online and via telephone interviews by Harris Interactive on behalf of AstraZeneca. The survey involved 1,062 physicians and patients from France, Germany, Italy, the United Kingdom and the US.

AstraZeneca

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 $26.47 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 FTSE4 Good Index.

Arimidex (anastrozole) is a trademark, the property of the AstraZeneca group of companies.

References

The ATAC Trialist Group -Effect of anastrozole and tamoxifen as adjuvant treatment for early-stage breast cancer; 100 month analysis of the ATAC trial -published online, Lancet Oncology Saturday 15 December
Forbes J, on behalf on the ATAC Trialist's Group. ATAC: 100 month median follow-up shows continued superior efficacy and no excess fracture risk for anastrozole compared with tamoxifen after treatment completion. Abstract no 41. San Antonio Breast Cancer Symposium 2007.
Parkin, D.M., E. Laara, and C.S. Muir, Estimates of the worldwide frequency of sixteen major cancers in 1980. Int J Cancer, 1988. 41(2): p. 184-97.
Breastcancer.org. What role to hormones play in breast cancer treatment. Available from http://www.breastcancer.org/treatment/hormonal/what_is_it/hormone_role.jsp. (Last accessed October 2007)
Cella et al, Quality of life of postmenopausal women in the ATAC ('Arimidex', Tamoxifen, Alone or in Combination) trial after completion of 5 years' Adjuvant Treatment for early breast cancer. Breast Cancer Research and Treatment, 2006. 100(3): p. 273-284.
Data on file, 'More Positive Conversations' global survey, conducted by Harris Interactive (US) March-May 2007.

NEW RESULTS FROM ONE OF THE WORLD'S LARGEST BREAST CANCER TRIALS HERALD HOPE FOR THOUSANDS OF WOMEN

Benefits of Arimidex (anastrozole) over tamoxifen at preventing all forms of breast cancer recurrence increase over time - even four years after treatment ends

ATAC 100-month results summary:

Notes to Editors

Broadcast-quality video

'More Positive Conversations' global survey

AstraZeneca

References

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Professor John Forbes, Newcastle Mater Misericordiae Hospital, Australia

Professor Anthony Howell, Christie Hospital, UK

Professor John Forbes, Newcastle Mater Misericordiae Hospital, Australia

ATAC 100 recurrence curve

Early breast cancer recurrence curve

How and where early breast cancer recurs

ATAC trial factsheet

About recurrence factsheet

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