New draft guidance from the National Institute for Health and Clinical Excellence (NICE) recommends that the NHS should use one test, Oncotype DX, to guide decisions about the use of chemotherapy in people with early breast cancer, but not three others. 

The draft is now out for consultation, and follows others on previous drafts and the submission of a confidential access proposal by the manufacturer of Oncotype DX.

It recommends the use of Oncotype DX in people with oestrogen receptor-positive (ER+), lymph node-negative (LN-) and human epidermal growth factor receptor 2 negative (HER2-) early breast cancer who are assessed as being at intermediate risk, to guide chemotherapy decisions where the manufacturer provides it at the price offered through the confidential access proposal. 

This recommendation applies to people assessed as being at intermediate risk of distant recurrence (metastasis) by decision-making tools and protocols current in use in the NHS and where the decision to prescribe chemotherapy remains unclear.

NICE says it has not been able to support the routine use of three other tests - IHC4, MammaPrint and Mammostrat. However, it does recommend that they are used in a research setting to collect evidence about potentially important clinical outcomes and determine their ability to predict the efficacy of chemotherapy in people with early breast cancer.

The four tests evaluated in the draft guidance measure the presence of multiple markers within the tumour that may indicate how it is likely to progress. Used in conjunction with other available information such as tumour size and grade, they aim to improve the targeting of chemotherapy in breast cancer by improving the stratification and identification of patients who are most likely to benefit from chemotherapy.

Some breast cancer patients with a "good" prognosis may still have recurrence after curative surgery and adjuvant therapy, while some patients considered to have a "poor" prognosis may never develop metastatic disease. This presents a challenge to clinicians to estimate prognosis and make the most appropriate decisions about the use of adjuvant chemotherapy in people with early-stage breast cancer, says NICE.

In the UK, clinicians use local protocols to estimate prognosis based on tools such as the Nottingham Prognostic Index or Adjuvant! Online, but with use of these tools it has been suggested that a proportion of people with early-stage breast cancer are over- or under-treated.

The decision whether to offer adjuvant chemotherapy is uncertain in people with ER+, LN- and HER2- early breast cancer, and NICE says the aim of this assessment is to evaluate whether, by better informing the selection of patients to receive adjuvant chemotherapy, gene expression or protein expression profiling tests improve health outcomes and quality of life in patients with this type of early-stage breast cancer compared with currently-used decision-making protocols.

"A test that can help predict the risk of distant recurrence and therefore the potential likely benefit of adjuvant chemotherapy in people with early breast cancer more accurately than the tools currently used would represent a significant step forward both for patients considering therapy and the NHS in terms of allocating resources,” said Professor Carole Longson, director of the health technology evaluation centre at NICE.

Based on the evidence considered, NICE's independent appraisal committee has concluded that the information on the biological features of the cancer provided by Oncotype DX may help in predicting the risk of distant recurrence and, following the submission of an access proposal by the manufacturer, it has been able to recommend Oncotype DX as a cost-effective option to guide treatment decisions in people with early breast cancer and an intermediate risk of distant recurrence, she said.

"The committee discussed the need for further robust evidence to demonstrate the ability of Oncotype DX to identify patients who will benefit most from chemotherapy," Prof Longson added.

The panel also concluded that evidence of the ability of the other three tests is currently uncertain, so the case was not made for their routine use.

However, it calls for further research to “collect evidence about potentially important clinical outcomes and to determine the ability of the tests to predict the efficacy of chemotherapy. NICE will assess the feasibility of the committee's research recommendations with a view to facilitating the development of further relevant evidence," Prof Longson concluded.

The consultation closes on March 11.