The National Institute for Health and Care Excellence (NICE) has today (Wednesday 10th January 2018) provisionally rejected the use of five tumour profiling tests.
The National Institute for Health and Care Excellence (NICE) has today (Wednesday 10th January 2018) provisionally rejected the use of five tumour profiling tests (EndoPredict, MammaPrint, Oncotype DX Breast Recurrence Score, Prosigna and IHC4+C) to guide treatment decisions on whether patients with a type of early breast cancer (ER-positive, HER2 negative, with 0-3 positive lymph nodes) should also receive chemotherapy following surgery to remove the tumour.
The tests provide information on the activity of genes in tumour samples which provide a risk profile that can help determine the likelihood of cancer recurring, helping to define the treatment pathway.
The draft guidance – available for public consultation until 31st January 2018 – updates NICE’s 2013 recommendation of Oncotype DX for guiding adjuvant chemotherapy decisions for those with people with ER-positive, lymph node-negative and HER2-negative early breast cancer at intermediate risk.
Baroness Delyth Morgan, Chief Executive at Breast Cancer Now, said:
“Tumour profiling tests like these can help accurately predict the risk of breast cancer returning, aiding doctors and patients in decisions about whether chemotherapy is necessary and enabling some women to safely avoid its gruelling side-effects. It’s therefore very disappointing that NICE has been unable to recommend any of these prognostic tools to help guide chemotherapy use on the NHS.
“In particular, this appears to be a backwards step for some patients [patients with hormone positive, HER2-negative, lymph-node negative breast cancer assessed using current tools as being at intermediate risk of recurrence], for whom guidance published in 2013 previously recommended the use of Oncotype DX. We now look forward to working with NICE to understand the clinical and economic drivers behind this revised recommendation.
“With studies to assess their long-term impacts ongoing, prognostic tests like these are showing real potential to personalise breast cancer treatment and ensure all patients are given the best chance of survival, while reducing overtreatment. We very much hope future trial results and further research will soon enable NICE to recommend the best and most cost-effective tumour profiling tests for routine NHS use.”