NICE diagnostics guidance
Issued: September 2013
DG10

Gene expression profiling and expanded immunohistochemistry tests for guiding adjuvant chemotherapy decisions in early breast cancer management: MammaPrint, Oncotype DX, IHC4 and Mammostrat

This is an extract from the guidance. The complete guidance is available at www.nice.org.uk/dg10

1 Recommendations

1.1 Oncotype DX is recommended as an option for guiding adjuvant chemotherapy decisions for people with oestrogen receptor positive (ER+), lymph node negative (LN−) and human epidermal growth factor receptor 2 negative (HER2−) early breast cancer if:

  • the person is assessed as being at intermediate risk and

  • information on the biological features of the cancer provided by Oncotype DX is likely to help in predicting the course of the disease and would therefore help when making the decision about prescribing chemotherapy and

  • the manufacturer provides Oncotype DX to NHS organisations according to the confidential arrangement agreed with NICE.

1.2 NICE encourages further data collection on the use of Oncotype DX in the NHS (see section 7).

1.3 MammaPrint, IHC4 and Mammostrat are only recommended for use in research in people with ER+, LN− and HER2− early breast cancer, to collect evidence about potentially important clinical outcomes and to determine the ability of the tests to predict the benefit of chemotherapy (see section 7). The tests are not recommended for general use in these people because of uncertainty about their overall clinical benefit and consequently their cost effectiveness.

The analysis leading to recommendation 1.1 was based on intermediate risk of distant recurrence being defined as a Nottingham Prognostic Index (NPI) score above 3.4. It is anticipated that an NPI score can be simply calculated from information that is routinely collected about people with breast cancer. Other decision-making tools or protocols are also currently used in the NHS and these may also be used to identify people at intermediate risk.