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A new test called IHC4 that is being considered for use on the NHS could identify patients at such low risk of their breast cancer returning after surgery that they may be spared chemotherapy, according to research published in the British Journal of Cancer today.
The study of 101 patients – conducted by scientists in the Breakthrough Breast Cancer Research Centre at The Institute of Cancer Research (ICR) and clinicians at The Royal Marsden Hospital – suggested that almost half of patients currently classified as at intermediate risk of recurrence would be downgraded to low risk by the test. This would mean they would potentially safely avoid chemotherapy and its toxic side effects.
The IHC4 test uses simple technology that is available in most treatment centres around the UK and is relevant to the treatment for patients with oestrogen receptor positive (ER positive) breast cancer. This is the most common type of the disease, accounting for around three out of four breast cancer cases, totalling around 36,000 patients in the UK each year. While many of these patients will benefit from chemotherapy, others have very low risk disease and this molecular test will help identify this group.
“This is a simple, cost-effective test. This new research suggests many additional patients could be classified as at low risk, and therefore avoid chemotherapy and its toxic side effects. This could make a big difference to those patients, and also save the NHS money. It is currently being assessed by NICE, the National Institute for Health and Clinical Excellence, for widespread use through the NHS.
“We need to extend this research with clinical and laboratory colleagues at other centres, but if the results continue to be positive then this test could be of considerable value to patients."
Professor Dowsett’s team compared the diagnosis of ER positive breast cancer patients using two current standard diagnostic tools with the new IHC4 test. They found 15 of 26 patients classified as intermediate risk by one existing test, called AoL (Adjuvant Online), would have been reclassified as low risk using IHC4. Twenty-four of 59 patients classified as intermediate risk by the second existing test, called NPI (Nottingham Prognostic Index), would have been moved to the lower-risk category using IHC4. Around 13 patients using this second test were also reclassified as high risk.
In its provisional guidance, NICE, the body which decides what drugs and technologies are cost-effective for use in the NHS in England and Wales, considered the test to be promising. The provisional guidance recommended the IHC4 test for further research to confirm its accuracy and benefits but rejected three other tests including Oncotype DX, which was considered too expensive. IHC4 has the potential to be very cost-effective for the NHS because it uses three tests already used in breast units, with one addition. Estimates suggest it could cost around £100-£200 per test, a fraction of the £2,000 it costs to use Oncotype DX.
This research was funded by Breakthrough Breast Cancer through the Mary-Jean Mitchell Green Foundation, Cancer Research UK and The Royal Marsden NIHR Biomedical Research Centre.