NICE has today published draft guidance on a test to help monitor doses of the chemotherapy drug 5-FU (fluorouracil) for people with colorectal, head and neck, stomach and pancreatic cancers. The draft guidance concludes that the My5-FU assay (Saladax Biomedical Inc.) is a potentially clinically important test for guiding dose adjustment of 5-FU chemotherapy but that there is insufficient evidence at present to show whether it is a clinically and cost effective test.
The draft guidance therefore recommends that the My5-FU assay is used in research settings in order to generate further robust evidence about its potential benefits.
The My5-FU assay is intended to be used in patients having 5-FU chemotherapy 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 determine whether an individual is receiving an optimal therapeutic dose of 5-FU and then to adjust the dose accordingly (a process known as pharmacokinetic dose adjustment). This may result in increased overall and progression free survival by increasing the number of people having an optimal therapeutic dose of 5-FU, and by reducing the side-effects and level of toxicity they experience.
The consequences for patients of 5-FU toxicity can include neuropathy (damage to nerve cells), severe damage to organs, heart damage (cardiotoxicity), neutropenia (low levels of white blood cells), sepsis (infection) and septic shock. In addition, people with DPD (dihydropyrimidine dehydrogenase) deficiency have a reduced ability to metabolise 5-FU and can develop serious toxicity following treatment with 5-FU.
Mirella Marlow, Programme Director for Devices and Diagnostic Systems at NICE, said: “The ability to reduce toxicity and improve the effectiveness of treatment through monitoring and adjusting the dose of 5-FU administered by infusion are important considerations for patients undergoing this treatment.
“Although the Committee felt that the My5-FU assay is a promising technology, there was not enough evidence to show whether adjusting the dose of 5-FU using the My5-FU assay is associated with increased progression free and overall survival when compared to current clinical practicei. There was also insufficient evidence to determine 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.
“The draft guidance therefore recommends that further research is carried out to demonstrate the usefulness of the My5-FU assay in clinical practice. 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 draft diagnostics guidance for My5-FU is available on the NICE website. The closing date for comments on the draft guidance is 5 September 2014.
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 draft guidance
- The draft 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
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