Thousands of women in the UK with breast cancer may now be able to avoid chemotherapy after a test to help determine its suitability was approved for the NHS by cost regulators.
The National Institute for Health and Care Excellence (NICE) has endorsed the use of the Oncotype DX test to help doctors decide whether to prescribe chemotherapy or not.
The test measures certain biological characteristics within the tumour that could indicate how it is likely to grow and whether the cancer is more or less likely to spread.
Taken together with other factors, such as tumour size and grade, the test is designed to improve the use of chemotherapy by identifying patients most likely to benefit from it.
A number of tools are already used by clinicians to decide whether or not to use adjuvant chemotherapy, but NICE says there is evidence that some patients are over- or under-treated.
"Trying to ensure the appropriate amounts of treatment are given is important to minimise the risk of harm to patients from over-treatment but also to prevent relapse of the cancer (a possible result of under-treatment)," the Institute said.
"A test that can help to predict better the risk of the breast cancer spreading, and therefore the potential likely benefit of additional chemotherapy, represents a significant step forward for patients," added Professor Carole Longson, NICE's Health Technology Evaluation Centre Director.
NICE's decision to approve the test was helped by an access proposal - the nature of which has been kept under wraps - put forward by the manufacturer to improve its cost-effectiveness.
The guidance also highlights that, because the evidence of the ability of the other three tests considered as part of this assessment - the IHC4, MammaPrint and Mammostrat - is currently uncertain, it has not been able to support their routine use to guide decisions about chemotherapy.
More effective alternative?
Earlier this year, UK scientists claimed they had developed a more accurate test than the Oncotype DX which, they noted, classes a large number of women in the 'intermediate risk' category for disease recurrence.
Researchers from the Institute of Cancer Research, The Royal Marsden NHS Foundation Trust and Queen Mary University of London found that the PAM50 test - which analyses 50 genes linked with breast cancer - provided more long-term predictive information than the others and, notably, detected more patients at high risk of their disease returning and classed fewer in intermediate risk group.
But a spokesperson for NICE told PharmaTimes World News that, while the PAM50 test was included in the original scope for its diagnostics guidance on gene expression profiling for breast cancer, the test, along with a number of others, "was subsequently removed from the scope because there was insufficient evidence for them to be included in the economic analysis performed by the external assessment group".