Women With Early Breast Cancer are More Likely to Remain Cancer Free by Changing Treatment From Tamoxifen to Arimidex(TM) (Anastrozole)

Macclesfield, England, November 17 (ots/PRNewswire) -


- Data Published in the Lancet Oncology Report That Patients areMore Likely to Live Cancer Free for Longer if Tamoxifen is ReplacedWith ARIMIDEXT(TM)

According to data published today in the Lancet Oncology, womenwith early breast cancer, who have their treatment swapped fromtamoxifen to ARIMIDEX(TM) (anastrozole) at 2-3 years, have a betterchance of living cancer free for longer than if they continue takingtamoxifen[1]. The data are from a meta-analysis of three keyinternational trials[2,3,4] and confirm that, in postmenopausalwomen with hormone-sensitive disease, replacing tamoxifen withanastrozole can almost halve the likelihood of disease recurrence.Furthermore, with survival being the ultimate goal, changingtreatments can reduce the risk of death by nearly a third.

Commenting on these data, lead author of the meta-analysis,Professor Walter Jonat of the University of Kiel, Germany said,"These data will be welcome news to the many thousands of womenaround the world who are currently taking tamoxifen to help preventthe recurrence of early breast cancer. By changing treatment, theirchances of beating the disease and living longer cancer free can begreatly improved, giving them more confidence for the future."

The three trials in the meta-analysis were similarly designed toassess, in women already being treated with tamoxifen, whether or notreplacing tamoxifen with anastrozole after 2-3 years was moreeffective than continuing to take tamoxifen for the full 5-yeartreatment period. The combined data show, at a median follow-up of 30months, that replacing tamoxifen with anastrozole can significantlyreduce recurrence, prevent metastatic spread and ultimately save thelives of many women with early breast cancer.

Women who changed to anastrozole, rather than remaining ontamoxifen, experienced a;

- 29% improvement in overall survival (HR 0.71; 95% CI 0.52 -0.98; p=0.0377), i.e. the risk of dying was reduced by almost a third

- 45% improvement in event-free survival (HR 0.55; 95% CI 0.42 -0.71; p<0.0001), i.e. the risk of the disease returning was reducedby almost half and

- 39% improvement in distant recurrence-free survival (HR0.61; 95% CI 0.45 - 0.83; p=0.0015)[1].

Getting it right from the start.

Although these data are a valuable finding for women alreadytaking tamoxifen for the treatment of hormone-sensitive, early breastcancer, it is important to remember that the findings do not apply towomen newly diagnosed with the disease. For these patients, recentevidence and opinion show the importance of using anastrozole ratherthan tamoxifen right from the start[5-7]. There are currently no datademonstrating any benefit of a planned sequencing strategy of twotherapies over 5 years of tamoxifen alone in patients with earlybreast cancer.

"The landmark ATAC trial established that starting treatment withanastrozole at the earliest opportunity after surgery, and giving itfor the full 5 years of treatment, is not only more effective thantamoxifen for the prevention of disease recurrence but bettertolerated as well. This would suggest that the best place to useanastrozole is right from the start. The important data published inthe Lancet Oncology today demonstrate that patients who have not hadthe benefit of starting treatment on anastrozole, can still gain fromthe significant benefits of anastrozole, by switching at 2 years,"stated Prof. Jeffrey Tobias of University College Hospital, London,United Kingdom.

Anastrozole was granted a new licence indication in Europe in July2006, confirming its approval for use following 2-3 years oftamoxifen therapy. This approval was granted on the basis of thedisease-free survival benefit for anastrozole demonstrated in thethree individual trials included in the meta-analysis. Anastrozole isnow the first and only aromatase inhibitor to be approved both forprimary adjuvant use and following 2-3 years' treatment withtamoxifen.


1. Jonat W, Gnant M, Boccardo F et al. Effectiveness of switchingfrom adjuvant tamoxifen to anastrozole in postmenopausal women withhormone-sensitive early-stage breast cancer: a meta-analysis. LancetOncology. Published online November 17, 2006DOI:10.1016/S1470-2045(06 )70948-2

2. Jakesz, R. et al. The benefits of sequencing adjuvant tamoxifenand anastrozole in postmenopausal women with hormone-responsive earlybreast cancer: 5 year-analysis of ABCSG Trial 8. Abstract No. 13. SanAntonio Breast Cancer Symposium 2005

3. Jakesz R, Jonat W, Gnant M et al. Switching of postmenopausalwomen with endocrine-responsive early breast cancer to anastrozoleafter 2 years' adjuvant tamoxifen: combined results of ABCSG trial 8and ARNO 95 trial. Lancet 2005; 366 (9484):455-462

4. Boccardo F, Rubagotti A, Puntoni Met al. Switching toanastrozole versus continued tamoxifen treatment of early breastcancer: Preliminary results of the Italian Tamoxifen Anastrozoletrial. 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 5years' adjuvant treatment for breast cancer. Lancet. 2005 Jan1-7;365(9453):60-62

6. Buzdar A, Chlebowski R, Cuzick J et al. Defining the role ofaromatase inhibitors in the adjuvant endocrine treatment of earlybreast cancer. Curr Med Res Opin 2006;22(8):1575-85

7. ATAC Trialists' Group. Comprehensive side-effect profile ofanastrozole and tamoxifen as adjuvant treatment for early-stagebreast cancer: long-term safety analysis of the ATAC trial. LancetOncology. 2006 Aug;7(8):633-43

For further information, please contact: Lynn Grant - AstraZeneca Global PR Director - Oncology Direct Line: +44-(0)-1625-517-406 Email: Lynn.Grant@Astrazeneca.com Elly Brookes - Shire Health International Direct Line: +44 (0) 20-7108-6533 Email: elly.brookes@shirehealthinternational.com

Notes to Editors

Meta-analysis includes:

ABCSG - Austrian Breast & Colorectal Cancer Study Group,

ARNO - 'Arimidex' - 'Nolvadex',

ITA - Italian Tamoxifen Anastrozole

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

AstraZeneca (LSE: AZN , NYSE: AZN) continues its tradition ofresearch excellence and innovation in oncology that led to thedevelopment 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 rangeof novel targeted products such as anti-proliferatives,anti-angiogenics, vascular targeting and anti-invasive agents.AstraZeneca is also harnessing rational drug design technologies todevelop new compounds that offer advantages over current cytotoxicand hormonal treatment options. The company has over 20 differentanti-cancer projects in research and development.

'ARIMIDEX', 'CASODEX', 'FASLODEX', 'NOLVADEX', 'ZOLADEX','TOMUDEX', and 'IRESSA' are trademarks, the property of theAstraZeneca group of companies.

AstraZeneca is a major international healthcare business engagedin the research, development, manufacture and marketing ofprescription pharmaceuticals and the supply of healthcare services.It is one of the world's leading pharmaceutical companies withhealthcare sales of $23.95 billion and leading positions in sales ofgastrointestinal, cardiovascular, neuroscience, respiratory, oncologyand infection products. AstraZeneca is listed in the Dow JonesSustainability Index (Global) as well as the FTSE4Good Index.

For more information, please visit www.astrazenecapressoffice.com

ots Originaltext: AstraZenecaIm Internet recherchierbar: http://www.presseportal.de

Contact:For further information, please contact: Lynn Grant - AstraZeneca, Global PR Director - Oncology, Direct Line: +44-(0)-1625-517-406. Email: Lynn.Grant@Astrazeneca.com. Elly Brookes - Shire Health International, Direct Line: +44 (0) 20-7108-6533, Email: elly.brookes@shirehealthinternational.com


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Women With Early Breast Cancer are More Likely to Remain Cancer Free by Changing Treatment From Tamoxifen to Arimidex(TM) (Anastrozole)