Hundreds of Thousands of Women With Early Breast Cancer Set to Benefit From Preliminary NICE Decision

LONDON, May 23 /PRNewswire/ --

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Hundreds of thousands of women with early breast cancer in England and Wales are set to benefit from life-saving hormonal treatments following the landmark preliminary guidance issued today by the National Institute for Health and Clinical Excellence (NICE) recommending the use of aromatase inhibitors (AIs) as an option for all postmenopausal women with hormone receptor positive (HR+) early breast cancer.

"This NICE decision is hugely exciting and heralds a whole new era in the treatment of postmenopausal women with HR+ early breast cancer in the UK. This will truly make a difference to the large majority of women affected by early breast cancer for many years - if not decades - to come," said Professor Mike Baum, Emeritus Professor of Surgery, University College London.

"By embracing these innovative treatments and recommending their use immediately after surgery, NICE has confirmed that AIs are becoming the 'gold standard' treatment and allowed all eligible women access to more effective and better tolerated medicines. Importantly, this guidance may help the NHS to further improve breast cancer mortality rates in the UK - which have been steadily falling over the years. I for one am delighted," Professor Baum added.

This preliminary NICE guidance recommends that the NHS in England and Wales fund AIs, the most significant advance in early breast cancer hormonal treatment for postmenopausal women with HR+ early breast cancer since the advent of tamoxifen, over 30 years ago. NICE recognises the "convincing evidence" that using AIs immediately after surgery is both clinically beneficial and cost-effective compared with generic tamoxifen, because of their increased effectiveness in preventing the cancer returning (recurrence) and improving disease-free survival - an important indicator of surviving breast cancer. In particular, NICE acknowledges the benefits of treating newly diagnosed women with AIs as early as possible after surgery because of the increased risk of recurrence during the first two years after diagnosis. NICE also stated it is cost-effective to switch women who are currently taking tamoxifen to an AI. The landmark decision confirms the strongly held view of breast cancer specialists in the UK that AIs are becoming the standard of care in the treatment of HR+ early breast cancer, effectively replacing the 30-year old treatment, tamoxifen.

"AstraZeneca welcomes NICE's draft guidance, which recommends that AIs should be an option for all HR+ postmenopausal women. This guidance will mean that the 23,000 women diagnosed with early breast cancer each year, plus the many thousands of women currently receiving tamoxifen, will be able to benefit from these life-saving medicines. The wealth of AI data demonstrating women are living cancer free for longer and at extremely good value for the NHS are compelling and have made a strong case for the wider use of AIs over tamoxifen," said Dr Rakesh Patel, Medical Leader, Breast Cancer at AstraZeneca.

The recommendations were based on the results of seven randomised controlled trials - the best scientific evidence available. Of the seven trials assessed, four involved anastrozole (Arimidex), including the largest independent breast cancer trial ever conducted in the world, which was led by the UK - the ATAC (Anastrozole, Tamoxifen, Alone or in Combination) study. The ATAC trial demonstrated that an additional one in four recurrences are prevented when taking anastrozole, compared with those taking tamoxifen.[1] Recurrence can lead to advanced breast cancer, for which there is no cure.

Anastrozole was the first AI licensed for the full five years of adjuvant treatment immediately following surgery in postmenopausal women diagnosed with HR+ early breast cancer.[2] It is the first and only AI with more than five years (68 months) of clinical efficacy and tolerability data in the post-surgery treatment of early breast cancer over tamoxifen.1

The NICE recommendations also highlight the importance of patient involvement and preference in making treatment decisions with their clinicians and acknowledge the important influence of treatment side effects on quality of life, including menopausal symptoms. It is important that women are fully informed and confident in discussing their treatment options with their specialists, to ensure that they are getting the best treatment to meet their needs.

Breast cancer patient, Anne Donald, has been taking Arimidex for almost two years and she is confident of the benefits of AIs. "When I started treatment with Arimidex it was like starting a new phase in life. All the results that I've heard about show that Arimidex is one of the leaders in the treatment of breast cancer for postmenopausal women. So I'm very lucky to be on it, and I'm delighted that now all women with early breast cancer will have access to this effective drug," said Anne Donald, Roath, Cardiff, Wales.

By recommending the use of AIs immediately after surgery over tamoxifen, the NICE decision supports the guidance issued on anastrozole by the Scottish Medicines Committee (SMC)[3] in September 2005.

The final NICE guidance will be issued to the NHS in England and Wales in November 2006. The NHS aims to provide funding for medicines recommended by NICE within three months of final guidance being issued.

Notes to Editors:

- The NICE Appraisal Consultation Document (ACD) can be found on http://www.nice.org.uk/

- The NICE Appraisal Consultation Document (ACD) is the first of two guidance stages in the ongoing NICE Health Technology Appraisal of hormonal therapies, which is assessing the clinical and cost effectiveness of all three AIs - anastrozole (Arimidex), exemestane (Aromasin) and letrozole (Femara) - in the treatment of early breast cancer compared with tamoxifen.

- The NICE Appraisal Consultation Document (ACD) guidance wording stated:

- The aromatase inhibitors anastrozole, exemestane and letrozole, within their licensed indications, are recommended options for the adjuvant treatment of early oestrogen-receptor-positive invasive breast cancer in postmenopausal women.

- The choice of treatment strategy (that is, starting treatment immediately after surgery with an aromatase inhibitor, switching from tamoxifen to an aromatase inhibitor or use of an aromatase inhibitor after completion of 5 years tamoxifen treatment) should be made after discussion between the responsible clinician and the patient about the risks and benefits of the options available.[4]

- Anastrozole has an annual cost of GBP896 and is the least expensive AI available - costing 18% less than letrozole and exemestane.[5] In comparison, the annual cost of trastuzumab (Herceptin) and taxanes, such as paclitaxel, are significantly higher.

- In September 2005, the SMC recommended anastrozole for first-line use in the treatment of early breast cancer in HR+ postmenopausal women, provided that treatment is initiated by a breast cancer specialist. The SMC provides advice to NHS Boards and their Area Drug and Therapeutics Committees (ADTCs) across Scotland about the use of treatments in NHS Scotland. The SMC issues guidance on all newly licensed medicines, all new formulations of existing medicines and any major new indications for established products.

- Anastrozole is the first of the 'third generation' AIs to challenge tamoxifen in the treatment of early breast cancer in over 30 years by gaining a licence in the UK and a recommendation from the SMC for use first-line in the treatment of postmenopausal women with HR+ early breast cancer.

- Anastrozole is the most comprehensively studied of all the AIs and the only one with efficacy and tolerability data for the full five-year (68 months) adjuvant setting.1

- Anastrozole is taken as a once-daily oral 1mg tablet.[6]

References:

[1] The ATAC Trialists' Group. Results of the ATAC (Arimidex, Tamoxifen, Alone or in Combination) trial after completion of 5 years' adjuvant treatment for breast cancer, Lancet 2005; 365: 60-62.

[2] Arimidex SmPC, June 2005

[3] Scottish Medicines Consortium, 5 August 2005: Anastrozole 1mg tablets (Arimidex(R)) for postmenopausal women with hormone receptor early invasive breast cancer http://www.scottishmedicines.org.uk/press/detail.asp?id=740http://www.scottishmedicines.org.uk/press/detail.asp?id=740

[4] NICE Appraisal Consultation Document - Hormonal therapies for the adjuvant treatment of early oestrogen-receptor-positive breast cancer, May 2006

[5] British National Formulary. http://www.bnf.org/bnf/

[6] Arimidex SmPC, June 2005

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