2006-06-04

Clinical Experience for 'Arimidex' (anastrozole) Passes Two Million Patient Years (i) Milestone


Macclesfield, England (ots/PRNewswire) -

- Evidence Drives More Clinicians to Choose anastrozole as Optimal Hormonal Therapy for Postmenopausal Women With Early Breast Cancer

AstraZeneca announced today, from the American Society of ClinicalOncology (ASCO) Annual Meeting, that anastrozole has this monthbecome the first aromatase inhibitor (AI) to accumulate over twomillion patient years' clinical experience. Since the mature resultsfrom the ATAC(i) trial clearly established the superiority ofanastrozole over tamoxifen in early breast cancer(1), anastrozole hasbecome the world's most used AI.

Commenting on this treatment revolution, Dr Buzdar of the MDAnderson Cancer Centre in Texas said: "When deciding what's best forour patients, we look to clinical evidence and guidelines to lead ourchoices. Anastrozole has consistently demonstrated that it's moreeffective and better tolerated than tamoxifen. Guidelines are nowstrongly recommending the use of an AI in early breast cancerpatients and anastrozole has the most experience and strongestevidence. It's not surprising then, that doctors are increasinglychoosing it to help their patients stay free from breast cancer aftersurgery, whilst avoiding some of the unpredictable and sometimesserious side effects that they risk with tamoxifen."

Bone health in postmenopausal women taking aromatase inhibitors

In recommending the use of AIs such as anastrozole in early breastcancer, recent treatment guidelines have also highlighted thatadditional evidence was needed regarding the effect of AIs on bonestrength. A 5-year update from the ATAC bone-sub-protocol, alsopresented today at ASCO confirms that, if women have a normal bonemineral density (BMD) at the outset, they can undergo a 5-year courseof treatment with anastrozole without the risk of developingosteoporosis.(2) These data have generated much excitement in themedical community as it is the first time that long-term data havebeen available on the effects of an AI on bone.

Although a reduction in BMD does occur over the 5-year course oftreatment with anastrozole, the rate of bone loss slows downsignificantly after the first 2 years. Normal reduction in BMDassociated with ageing is approximately 2-3% over 5 years; the boneloss seen with anastrozole is slightly higher (average, 6.1% in thelumbar spine and 7.2% in the hip) but is not significant enough tolead to osteoporosis (bone loss of 15-20%). Separate data have alsosupported the fact that the rate of bone fracture among women takinganastrozole is comparable to the normal patient population of thatage group.(3,4) Clinicians who may have previously been reluctant toprescribe anastrozole, because of the unconfirmed effect on bone, cannow be more confident that it not only offers their patients asignificantly better chance of staying cancer-free, any side effectssuch as a reduction in bone strength are predictable and manageable.

Switching from tamoxifen to anastrozole

Additional data presented at ASCO today further support thebenefits of anastrozole over tamoxifen. Although it is clear thatpostmenopausal women with early breast cancer gain the greatestbenefit from starting anastrozole treatment immediately aftersurgery, those who have already commenced treatment with tamoxifen donot have to miss out on the superior efficacy and tolerability of thenewer drug. New data from the prospective 'Arimidex'-'Nolvadex' 95(ARNO) study are the first data from a single trial to confirm thatstopping tamoxifen and switching to anastrozole can potentially savelives.(5) These data are consistent with previous meta-analysis datafrom three trials (presented at SABCS(iii) 2005)(6) which alsodemonstrated an improvement in overall survival among women whoswitched treatments.

"It's reassuring to know that the data for anastrozole continue tojustify the confidence that we as clinicians already have inselecting it as the optimal treatment for our postmenopausal earlybreast cancer patients. The increasing evidence base for AIscontinues to confirm that tamoxifen is not the most effective or safedrug we can offer our patients to keep them free from recurrence,"concluded Dr Buzdar.

References

1. ATAC Trialists' Group. Lancet 2005; 365: 60-62.

2. Coleman R. Proceedings of the American Society of Oncology (ASCO),2006. Abs 511.

3. Fisher B et al. J Natl Cancer Inst 1998; 90: 1371-1388.

4. Women's Health Initiative Writing Group. JAMA 2002; 288: 321-333

5. Kaufmann M. Proceedings of the American Society of Oncology (ASCO), 2006. Abs 547.

6. Jonat W. Proceedings of the San Antonio Breast Cancer Symposium, 2005

Notes to Editors

(i) Patient years calculations: Patient takes one tablet per day and there are 365 days per year.

Therefore, total tablets sold since launch divided by 365 = number of patient years

(ii) ATAC Trial: 'Arimidex' Tamoxifen, Alone or in Combination

(iii) SABCS: San Antonio Breast Cancer Symposium

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.

'Arimidex' is a trademark, the properties of the AstraZeneca group of companies.

For further information, please visit our websites www.astrazenecapressoffice.com and BreastCancerSource.com

Originaltext: AstraZenecadigital press kits: http://presseportal.de/story.htx?firmaid=18044press kits via RSS: feed://presseportal.de/rss/pm_18044.rss2

Lynn Grant, AstraZeneca, Global PR Director, Oncology, Direct Line: +44-1625-517-406, Mob: +44-7715-484-917, Email: Lynn.Grant@Astrazeneca.com. Elly Brookes, Shire Health International,Mob: +44-7768-553-210,Email: elly.brookes@shirehealthinternational.com. Sara Singer, Shire Health International,Mob: +44-7881-810-328, Email: sara.singer@shirehealthinternational.com

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Clinical Experience for 'Arimidex' (anastrozole) Passes Two Million Patient Years (i) Milestone

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