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Final guidance published yesterday by NICE recommends that further research is carried out on a promising test to help monitor doses of the chemotherapy drug 5-FU (fluorouracil) for people with colorectal, head and neck, stomach and pancreatic cancers.

The My5-FU assay (Saladax Biomedical Inc.) is a test for guiding dose adjustment of 5-FU chemotherapy when it’s given by continuous infusion. Blood plasma is tested at the end of each infusion cycle, and the results of the My5‑FU test are used to guide the dosing of 5-FU in the next cycle.

The test helps clinicians to decide whether an individual is receiving the most advantageous (optimal) therapeutic dose of 5-FU and then to adjust the dose accordingly (a process known as pharmacokinetic dose adjustment). By ensuring people receive an optimal therapeutic dose of 5-FU, this could potentially increase overall survival or delay the disease returning. It could also reduce the side-effects and level of toxicity some individuals experience.

The consequences for patients of 5-FU toxicity can include damage to nerve cells (neuropathy), and organs, heart damage (cardiotoxicity), increased susceptibility to infections because of low levels of white blood cells (neutropenia), sepsis (infection) and septic shock.

Professor Carole Longson, NICE Health Technology Evaluation Centre Director, said: “Being able to reduce toxicity and improve the effectiveness of treatment through monitoring and adjusting the dose of 5-FU given by infusion are important considerations for patients having this treatment.

“The Committee felt that, although the My5-FU assay is a potentially clinically important test for guiding dose adjustment of 5-FU chemotherapy, there was not enough evidence to show whether adjusting the dose of 5-FU using the assay is associated with increased progression free and overall survival when compared to current clinical practicei.

“There was also not enough evidence to show whether its use would have a substantial impact on 5-FU-related toxicities, other than diarrhoea, which may be associated with a reduction in quality of life.

“NICE’s research team will consider how trials involving MY 5-FU can be designed so that they reflect the research recommendations in the draft guidance.”

The diagnostics guidance for My5-FU is available on the NICE website.

For more information call the NICE press office on 0300 323 0142/pressoffice@nice.org.uk or out of hours on 07775 583 813.

Notes to Editors

Explanation of terms

• Current NHS practice for calculating the dose of 5-FU a patient will have is body surface area (BSA) dosing. BSA is calculated by formulae which use the patient’s height and weight, and is said to correlate with blood volume, cardiac output and renal function, all of which influence drug elimination. The dose may be adjusted to take into account a patient’s liver and kidney function, both of which may impact upon how 5-FU is metabolised and excreted. A 5-FU dose may also be adjusted according to the severity of any side effects that a patient may experience.

About the guidance

• The guidance on the My5-FU assay for guiding dose adjustment of 5-FU chemotherapy is available on the NICE website

About the NICE Diagnostics Assessment Programme 

• For further information about the NICE diagnostics assessment programme see Developing NICE diagnostic technologies guidance  

Topics to be considered by the Programme are routed through the related Medical Technologies Evaluation Programme. Further information about this can be found at Developing NICE medical technologies guidance

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.

Our aim is to help practitioners deliver the best possible care and give people the most effective treatments, which are based on the most up-to-date evidence and provide value for money, in order to reduce inequalities and variation.

Our products and resources are produced for the NHS, local authorities, care providers, charities, and anyone who has a responsibility for commissioning or providing healthcare, public health or social care services.

To find out more about what we do, visit our website:www.nice.org.uk and follow us on Twitter: @NICEComms.