AstraZeneca welcomes the National Institute for Health and Clinical Excellence (NICE) Early Breast Cancer (EBC) clinical guideline (1) that recommends upfront use of aromatase inhibitors (AIs), such as anastrozole (Arimidex),Anastrozole (Arimdex)(2) in women who are not deemed to be low risk, which will help to ensure that postmenopausal women with oestrogen (ER) positive EBC receive the most appropriate treatment available. Published today, the NICE Breast Cancer (early and locally advanced): Diagnosis and Treatment clinical guideline (1) elevates AIs over the previous gold standard treatment, tamoxifen, for newly diagnosed breast cancer sufferers who are not deemed to be low risk.

Astra Zeneca welcomes this recommendation as it will encourage more consistency in treatment practices across the country for early breast cancer - meaning that the 23,000 postmenopausal women diagnosed with breast cancer in the UK each year(3) are more likely to be treated with AIs immediately after surgery to help reduce the risk of early recurrence.

Professor Michael Baum, Professor Emeritus of Surgery and Visiting Professor of Medical Humanities, University College London said: "It is great news that NICE has acknowledged the wealth of data that supports the initiation of AIs immediately after surgery. All women with early breast cancer are at the greatest risk of recurrence in the first 2-3 years after surgery, regardless of the factors affecting the course of the disease. This guideline will help ensure women receive the most appropriate hormonal treatments available - ultimately helping to prevent their cancer returning."

AstraZeneca acknowledges the recommendation to offer a baseline bone scan to assess bone mineral density to all women starting an AI. (1) In the Arimidex, Tamoxifen Alone or in Combination (ATAC) trial women who had normal bone mineral density when entering the trial did not become osteoporotic after 5 years of treatment with anastrozole.(4) Data from the ATAC 100 trial showed the increased yearly fracture rate noted during treatment did not continue into the post-treatment follow-up period, where the fracture rate on anastrozole at 9 years was very similar to that with tamoxifen.(5)

AstraZeneca also acknowledges the NICE recommendation to offer an AI, such as anastrozole, instead of tamoxifen to postmenopausal women with ER positive EBC, who are not low risk and who have been treated with tamoxifen for 2-3 years. (1) However AstraZeneca would like to emphasize that there is no evidence that a planned sequencing strategy is superior to a 5 year AI strategy for newly diagnosed women with early breast cancer.

Advanced Breast Cancer

Today, NICE also published a clinical guideline for the diagnosis and treatment of advanced breast cancer (ABC) which highlights the place of endocrine therapies in this setting, including AIs and fulvestrant (Faslodex). Fulvestrant (Faslodex) (6).However, AstraZenca is disappointed that there is no mention of fulvestrant in the final recommendations, despite it being proven to be at least as effective as anastrozole in the treatment of postmenopausal women with advanced hormone receptor positive breast cancer, whose disease has relapsed on or after adjuvant antioestrogen therapy or progressed on therapy with an antioestrogen.(7 -9),

Professor Baum commented "Women should be fully informed of the advantages and disadvantages of medical and surgical treatment, understanding the overall benefits of treatment and the impact treatment has on quality of life. In the unfortunate instance that a women's breast cancer has progressed, it is important that everything possible is done to improve the patient's quality of life. Use of fulvestrant increases the options available to clinicians, delaying the need to start chemotherapy following failure of prior endocrine therapy."

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References

1. NICE (February 2009) Early and locally advanced breast cancer: diagnosis and treatment.

2. Anastrozole (Arimdex) SmPC. medicines

3. Technology Assessment Report commissioned by the HTA. Programme on behalf of The National Institute for Clinical Excellence. 'Hormonal therapies for early breast cancer: systematic review and economic evaluation'.

4. Coleman R. Effect of anastrozole on bone mineral density and bone fractures: results from the 'Arimidex'' (anastrozole), tamoxifen, alone or in combination (ATAC) trial.European Journal of Cancer Supplements 2004;2(3):140, Abs 289.

5. The ATAC Trialists' Group. Effect of anastrozole and tamoxifen as adjuvant treatment for early-stage breast cancer; 100- month analysis of the ATAC trial. The Lancet Oncology , 2008; 9 (1) 45-53.

6. Fulvestrant (Faslodex) SmPC. medicines

7. Robertson JF, Osborne CK, Howell A et al. Fulvestrant versus anastrozole for the treatment of advanced breast carcinoma in postmenopausal women. Cancer 2003; 98 (2): 229-238.

8. Howell, A. et al. Fulvestrant, Formerly ICI 182,780, Is as Effective as Anastrozole in Postmenopausal Women With Advanced Breast Cancer Progressing After 9 Prior Endocrine Treatment. Journal of Clinical Oncology, 2002; 20 (16):3396-3403.

9. Osborne C.K et al. Double blind, randomised trial comparing the efficacy and tolerability of fulvestrant versus anastrozole in postmenopausal women with advanced breast cancer progressing on with prior endocrine therapy: Results from a North American Trial. Journal of Clinical Oncology, 2002; 20 (16):3386-3395.

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