Landmark trial to predict need for chemo in breast cancer patients

A landmark trial looking at a test to predict who needs chemotherapy for breast cancer has begun at University College London Hospitals (UCLH).

The OPTIMA (Optimal Personalised Treatment of breast cancer using Multi-Parameter Analysis) trial aims to use genomic tests to identify breast cancer patients who are likely to benefit from chemotherapy and spare those who are unlike to benefit from an unnecessary treatment.

Participants in the NIHR-funded trial will be assessed using a genomic test called Prosigna (PAM50) which analyses the activity of a group of genes that can affect how a cancer is likely to behave and respond to treatment. The OPTIMA trial aims to show that patients with a low tumour Prosigna score can be safely treated without chemotherapy.

The OPTIMA trial will aim to recruit 4,500 men and women over four years and will be run in over 120 hospitals across the UK, making it the largest currently recruiting breast cancer trial in the UK and the largest ever UK chemotherapy trial.

The trial has been awarded £5.33 million by the NIHR Health Technology Assessment (HTA) programme which funds research relating to the effectiveness, costs and broader impact of healthcare treatments and tests for those who plan, provide or receive care in the NHS.

Rob Stein, consultant oncologist at UCLH who is leading the trial, said: ““OPTIMA is designed to demonstrate that the Prosigna test predicts the sensitivity of individual cancers to chemotherapy. Using tumour tissue removed at surgery, the test measures the activity of 50 genes within the tumour and combines these to give a numerical score. Patients with a score more than 60 will receive chemotherapy in addition to endocrine therapy, those with lower scores receive endocrine therapy alone.

“Working out which patients do not need chemotherapy is difficult and new genomic tests performed on tumour tissue removed by the surgeon may solve this problem.”

Stein and his team predict that, if their assumptions about the Prosigna test are correct, the total savings to the NHS from the resulting reduction in chemotherapy usage will be £11.5-£17 million per year.

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This story was first published in digitalhealth.net

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