NICE has issued an appraisal consultation document (ACD) concerning four tests that are used after primary surgery to inform decisions on the use of adjuvant chemotherapy in women with breast cancer. Two of the tests are based on gene expression profiling (MammaPrint and Oncotype DX) and two are based on immunohistochemistry (also known as protein expression profiling; IHC4 and Mammostrat).
The preliminary recommendations are as follows:
1.1 MammaPrint, Oncotype DX and Mammostrat are not recommended to guide the use of adjuvant chemotherapy in women aged 75 years or under with oestrogen receptor (ER) positive, lymph node (LN) negative and human epidermal growth factor receptor 2 (HER2) negative early breast cancer. The Committee could not recommend these tests because of uncertainty in the evidence of clinical effectiveness leading to uncertainty about the cost effectiveness.
1.2 IHC4 is recommended for use in research in women with oestrogen receptor (ER) positive, lymph node (LN) negative and human epidermal growth factor receptor 2 (HER2) negative early breast cancer to collect evidence about potentially important clinical outcomes. Although the modelling suggested that IHC4 could be both beneficial and cost saving, weaknesses in the evidence base meant that it could currently only be recommended for use in research studies to collect data needed to reduce the uncertainty on clinical and cost effectiveness.
Please see the link below for further information.