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NICE recommends preventive breast cancer drugs for 'at risk' women


Updated guidance on breast cancer care released from NICE recommends use of preventive tamoxifen or raloxifene for women with a family history of the disease.

The recommendations are based on a number of recent research studies showing a significant reduction in the risk of developing breast cancer if one of the drugs is taken as a prophylaxis for five years.

For example, a recent meta-analysis published in The Lancet included results from many of the recent trials.

The NICE Committee estimated that around 3% of women in the UK aged 35 years or older would be eligible to receive prophylactic tamoxifen or raloxifene under the new guidelines, translating to approximately 488,371 women overall.

A cost-effectiveness analysis showed that use of the two drugs in this way would be cost effective. Both drugs are inexpensive - for example, tamoxifen costs about £25 a year - and if "that stops someone from developing breast cancer, it saves the NHS the cost of chemotherapy and surgery as well as saving the distress to the woman," a NICE spokesperson told APM by email.

The known side effects of tamoxifen and raloxifene, such as increased thromboembolic events and higher endometrial cancer risk, were taken into account by the committee, but they "concluded that the benefits for these particular groups of women far outweighed the risks," according to the NICE spokesperson.

Neither tamoxifen nor raloxifene is licensed for breast cancer prevention in the UK, although the U.S. Food and Drug Administration has licensed them in this way.

"For the recommendations on using tamoxifen or raloxifene as a way to prevent breast cancer, a group of leading experts and patients came together to assess the available published evidence and concluded that the treatments were proven to be safe and effective for these women," added the spokesperson.

"This is a major step forward in the way we can prevent breast cancer and one that gives women more options to help them take control of their risk and do something about it. The drugs do not need a licence for doctors to prescribe it but doctors must be confident that the evidence shows it to be safe and effective."

The guidelines call for further research to compare the effectiveness of aromatase inhibitors such as exemestane with tamoxifen and raloxifene for breast cancer prevention, as some evidence suggests they may also be effective in this way.

Call for more genetic testing to assess cancer risk

In addition to the new drug recommendations, the guidance suggests that the current threshold for genetic testing should be halved and that more people with a family history of cancer but no personal history of cancer should be offered genetic testing to assess their risk.

Professor Gareth Evans, a consultant in clinical genetics at St Mary's Hospital in Manchester who helped to develop these recommendations, commented in a statement by NICE: "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."

Yearly MRI screening for those with history of breast cancer

Another important recommendation in the new guidelines was that MRI screening should be offered to all women between the age of 30 and 49 years with breast cancer or a history of the disease.

In an email comment to APM, Professor Peter Johnson, Cancer Research UK's chief clinician, said: "The new recommendations give doctors a more effective way to estimate a woman's risk of developing the disease. This depends on age and family history, when to offer genetic testing or surveillance - such as MRI scans - and when to offer preventative treatment such as mastectomies or drugs like tamoxifen or raloxifene."


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