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NICE backs diagnostic test for breast cancer chemo

Chemotherapy for breast cancer in the early stages is the subject of new draft guidance from NICE’s Diagnostics Assessment Programme.

Published on Monday, the guidance looks at four tests used by medical professionals to help them decide whether chemotherapy would be an effective treatment for patients with early breast cancer.

It takes into account the results of consultations on drafts which have already been published as well as a confidential access proposal submitted by the company, which makes the diagnostic test Oncotype DX.

The new draft guidance recommends that Oncotype DX is used on early breast cancer patients whose cancer is oestrogen receptor positive (ER+) but lymph node negative (LN-) and human epidermal growth factor receptor 2 negative (HER2-).

NICE says the test should be used to help decide whether chemotherapy should be used on these patients where it is considered that there is an intermediate risk of the disease returning in the future.

The recommendation is on the condition that Oncotype DX is provided by the manufacturer at the price mentioned in its confidential access proposal.

However, NICE is not recommending the routine use of three other diagnostic tests - IHC4, MammaPrint and Mammostrat. But it does say they should be used as part of breast cancer research to look at how well tests can predict how well patients with the disease in its early stages will respond to chemotherapy.

All four tests looked at in the draft guidance measure whether the tumour has markers which can give medical professionals a better idea of the likely progression of the disease.

The tests can help medical professionals work out which patients are the most likely to see good results from chemotherapy, along with other details such as the size and grade of their tumour.

Director of NICE’s health technology evaluation centre Professor Carole Longson said that a test which could accurately predict the risk of breast cancer returning in the distant future better than the tools already used in the NHS would be very helpful in helping doctors and patients decide whether chemotherapy was necessary.

She said the committee had looked at all the evidence and decided that Oncotype DX would potentially be the most helpful in predicting the risk of distant recurrence in early breast cancer patients.

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