Hundreds of thousands of women across England and Wales could be spared the distress and uncertainty of a breast cancer diagnosis by taking a daily pill to help prevent the disease. Updated guidance by the National Institute for Health and Care Excellence (NICE) says the NHS should give tamoxifen or raloxifene to particular groups of women with a family history of cancer[1] because the drugs can help stop them getting breast cancer if they are taken for five years.

Roughly 50,000 women and 400 men are diagnosed with breast cancer each year in the UK[2], making it the most common cancer in the country. Of these breast cancer cases, one in five will be associated with a family history of the disease while hundreds of thousands of otherwise healthy people will be at risk of developing the disease because it runs in their family.

Professor Mark Baker, Director of the Centre for Clinical Practice at NICE, said: “People are considered to have a family history of cancer if a number of their relatives have lived through, or died from, certain cancers like breast, ovarian or prostate.

“Currently, if someone has a family history of cancer, there are two options available to them. If they are tested and are found to have a genetic reason for their family's cancer history, they may be eligible for annual screening so that any tumour will be detected early on. Or, they can opt for surgery to remove their breasts. These genetic mutations can also cause ovarian cancer so in some cases women may also decide to have their ovaries removed. This is major surgery and can be very traumatic for those involved.

“Our updated guideline now gives women more options in how they manage their risk of breast cancer; those with a ‘moderate' or ‘high' risk of developing breast cancer because of their family history but who have not had the disease themselves can now be offered tamoxifen or raloxifene for five years to prevent it. Although neither drug is licensed as a preventative treatment in the UK, clinical evidence shows they are an effective option for many women and could be preferable to surgery.”

As well as the new recommendations on drugs to prevent the disease, the updated NICE guideline also calls for more men and women to be tested for genetic mutations[3] that cause cancer and can be passed down through families. Not only does it recommend halving the ‘threshold' at which genetic testing is offered but now it says the NHS should offer testing to otherwise healthy people if it's likely they have a genetic mutation and have no living relative with cancer who could be tested instead.

Professor Gareth Evans, a Consultant in Clinical Genetics at St Mary's Hospital in Manchester who helped to develop these recommendations, said: “Reducing the threshold for genetic testing will inevitably mean more men and women being seen but this is something that's already happening in some parts of the country. Testing unaffected relatives will also have an impact on services but genetic clinics are able to carry out testing much quicker nowadays - between four and six weeks in some cases - and the cost of genetic testing is dropping substantially. Weighted against the possibility of preventing breast cancer in high-risk women, this is a cost-effective option for the NHS.

“The whole guideline is a major move forward in that more women than ever before now face the possibility of doing something tangible to reduce their risk of breast cancer.”

Other important new or updated recommendations include:

• Doctors should calculate a person's risk of getting breast cancer by assessing their family history and using a proven method[4]to calculate the possibility of that person carrying a genetic fault such as a BRCA1or BRCA2 mutation, whenever these methods are available in hospitals. The guideline advises doctors to use their clinical judgement when deciding whether to offer genetic testing if they have problems interpreting the results.
• Genetic testing in specialist clinics should be offered to a relative who has had breast and/or ovarian cancer if that family member has a 10% or more chance of carrying either a BRCA1 or BRCA2 genetic mutation (the threshold was previously set at 20%).
• MRI screening should be offered every year to all women aged 30-49 years who have, or have had, breast cancer and who remain at high risk of the disease. This includes those with a BRCA1 or BRCA2 mutation.

Maggie Alexander, Chair of the Guideline Development Group (GDG) that developed the recommendations on behalf of NICE, said: “It's so important for the NHS to continue to have clear, up-to-date guidance on this issue. It can be very easy to ignore someone's ‘risk' of disease and only concentrate on medical conditions once they develop.

“While not all of the causes of breast cancer are understood, we do know that having a family history of cancer can increase someone's chances of developing the disease - substantially so in some cases. Breast cancer can cost lives and has a devastating impact on many families. That's why the NHS has a duty to look after people who known to be at risk; they need the best, most effective care possible so that tumours can either be prevented or caught and treated as early as possible. These updated NICE recommendations reflect the best available evidence about what course of action will be most effective.”

Dr Caitlin Palframan, Assistant Head of Policy at Breakthrough Breast Cancer and GDG member, said: “Today's new guidelines are a game changer in the way we prevent breast cancer. Our strongest tool in the fight against breast cancer is prevention, and these new guidelines are a fantastic leap forward in the way we prevent breast cancer developing in those at highest risk.

“It is so important that people have an array of options available to them to assess and manage their own breast cancer risk. And for those at highest risk, which we must remember is a relatively small number of people in the population, it is equally vital that their options go beyond screening or surgery; through the use of preventative medicine, these new guidelines will help achieve this.

“From here the next challenge is ensuring the NHS is equipped to deliver on the promise of these recommendations; more screening, genetic testing and better preventative options for those few people at highest risk, and Breakthrough will be working to ensure that patients get the benefit of these incredibly valuable guidelines.”

The updated guideline on familial breast cancer is now available from the NICE website. While not mandatory, NICE clinical guidelines are regarded as best practice and the NHS is encouraged to follow the recommendations as set out in the guidance.

Ends

Notes to Editors

The guideline is available to view from Tuesday 25 June 2013. Embargoed copies are available upon request from the NICE press office.

About the guidance

• This guideline focuses on the management of people with a family history of breast, ovarian or another related cancer (e.g. prostate or pancreatic) and who are subsequently at increased risk of developing breast cancer. The 2013 update of this guideline, which is currently in development, also includes people who have been diagnosed with breast cancer and who have a family history of the disease.
• A family history of breast cancer is a known risk factor for breast cancer. The stronger the family link is, the more a person's likelihood of developing the disease is increased. The risk of developing breast cancer can depend on;
  • the nature of the family history
  • the number of relatives who have developed breast, ovarian or a related cancer
  • the age at which relatives developed breast cancer
  • the age of the person in question
• It is thought that around 3% of all women aged 35 or older in England and Wales could be eligible to receive either tamoxifen or raloxifene as a treatment to prevent breast cancer. With 16,291,025 women in this age group living in England and Wales in 2011[5], this would equate to roughly 488,371 women.
• Neither tamoxifen nor raloxifene are currently licensed as preventative treatments for breast cancer, although they are approved for this use in the U.S. Tamoxifen is given to women after surgery and chemotherapy for breast cancer, to help stop the tumour from returning. Raloxifene is currently licensed to help treat osteoporosis in women who have gone through the menopause. However, the evidence suggested that both treatments are equally effective in preventing breast cancer, reducing a person's risk by around a third (30-40%). The guideline states that if a doctor wants to prescribe either of these drugs as a preventative treatment for breast cancer, they should follow relevant professional guidance, taking full responsibility for the decision. Informed consent should also be obtained from the woman and documented.
• The guideline refers to people at ‘near population risk' (the average level of risk for the entire population. This is deemed to be a ‘normal' level of risk), ‘moderate risk' and ‘high risk'. These terms are defined in the updated guideline as follows

• This guideline is an update of the Institute's familial breast cancer guideline which was originally published in 2004 and updated in 2006. This 2013 update focuses on specific areas of care where new evidence has been published since 2006.
• The NHS Breast Screening Programme will offer a programme of more intensive surveillance from a younger age to women at higher risk of breast cancer. Those eligible include women with a BRCA1 or BRCA2 mutation. Those aged 30-39 years will be offered annual screening using MRI. Those aged 40-49 will be offered annual screening with MRI plus mammography.
  

About NICE

The National Institute for Health and Care Excellence (NICE) is the independent body responsible for driving improvement and excellence in the health and social care system. We develop guidance, standards and information on high-quality health and social care. We also advise on ways to promote healthy living and prevent ill health.

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