NICE breast cancer criteria missing patients, claims study

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Chris Karidis

Statue of Boadicea and her daughters, near Westminster Bridge in London.

The criteria developed by UK health technology assessment (HTA) agency NICE to decide who should be referred by GPs for further breast cancer risk assessment miss up to 95% of younger women who go on to develop the disease.

That is the conclusion of a study by researchers at the University of Cambridge and The Institute of Cancer Research (ICR) in London, which found that an alternative tool – dubbed BOADICEA – identified eight times as many at-risk women in the under-50 age group.

The findings, published in the British Journal of Cancer, come from an analysis of family history, reproductive, lifestyle and polygenic risk data among 1,258 women aged under 50 years recruited to the Breast Cancer Now Generations Study between 2004 and 2011.

Using NICE's current criteria for assessment would result in 1.4% of women under 50 being referred for further assessment, a group that would include just 4.4% of those who go on to develop breast cancer within 10 years.

In contrast, using the BOADICEA risk-assessment tool, 26.5% of women would be categorised as at above-population-level risk and referred for further assessment and specialist care, including 34.8% of those who develop breast cancer later.

So why the disparity? According to the researchers behind the study, led by Dr Juliet Usher-Smith from the Department of Public Health and Primary Care at Cambridge, a key reason is the reliance on family history of breast cancer in the NICE criteria. In fact, almost three-quarters of women (73%) under 50 who develop breast cancer within the next decade have no family history of the disease.

"The current NICE criteria used in general practice are missing up to 95% of women under 50 who will go on to develop breast cancer," said Usher-Smith. "It's time to look again at these criteria in the light of our findings. We need to get better at identifying women at highest risk of breast cancer so that we can intervene early, when there are more options for treating, or even preventing, their disease."

That said, deploying BOADICEA risk assessment at scale to all women in this age group in England would be far more resource-intensive and lead to more patient referrals, many of whom will not develop breast cancer.

"Ultimately, it will be a trade-off between the practical, resource, and cost implications of data collection and risk assessment, and the potential benefits and harms associated with accurate and inaccurate classification of women," commented Prof Montserrat Garcia-Closas of the ICR.

The authors of the study conclude that multifactorial risk assessment in primary care could substantially improve the identification of women at risk, who could then be offered interventions before being invited to population-based screening.

One commentator on the findings, cancer epidemiologist Prof Paul Pharoah of Cedars-Sinai Health Sciences University in the US, said the research was high quality, but the premise underlying the work is flawed.

NICE guidelines are intended to guide the management of women who present to their GP because they are worried about their family history of breast cancer, not to identify women at high risk, he argued, so the low identification rate would be expected.

Also, he questioned how identifying women under the age of 50 who are high risk enables early intervention to prevent or treat breast cancer.

"There are no good data to show that any intervention, such as mammographic screening, in these women improves outcomes," said Pharoah. "There is no good rationale for widespread risk prediction in these women."

On that point, Dr Adam Brentnall, reader in biostatistics at Queen Mary University of London (QMUL), noted that a UK randomised trial published in 2015 showed annual mammography screening of women in their 40s can reduce breast cancer deaths.

Photo by Chris Karidis on Unsplash