Landmark trial to predict need for chemotherapy in breast cancer patients 

06/11/2017 00:00 
A landmark trial looking at a test to predict who needs chemotherapy for breast cancer has begun at 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 unlikely to benefit from an unnecessary and unpleasant treatment.

Participants in the NIHR funded trial, which is led by Professor Rob Stein, a consultant oncologist at UCLH, will be assessed using a genomic test called Prosigna (also known as 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.

Professor Stein 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.”

Breast cancers that have spread to the axillary lymph nodes (lymph nodes under the armpit) are more likely to come back in the future. It is normal clinical practice to advise chemotherapy as well as hormone therapy when this happens. However, previous research suggests this type of breast cancer is often not sensitive to chemotherapy and that many patients would do just as well with hormone therapy alone.

Professor Stein said: “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.”

Previous studies that have suggested genomic tests can identify which tumours are not chemotherapy sensitive were on small numbers of women treated in historical breast cancer trials.  The OPTIMA trial will aims to recruit 4,500 men and women over four years and will be run in over 120 hospitals across the UK, making OPTIMA the largest currently recruiting breast cancer trial in the UK and the largest ever UK chemotherapy trial.

Patients who can join the trial would usually be treated with both chemotherapy and hormone treatment. The trial will compare the results of treatment of patients made using the Prosigna test to decide who should have chemotherapy with standard care. To enable this comparison, trial participants will be randomly assigned to one of two groups: one will all receive chemotherapy; the other will have a sample of tumour tissue tested by Prosigna.  Only patients with high scores receive chemotherapy and every patient will receive hormone treatment.

Adrienne Morgan, a research scientist from Clerkenwell, underwent chemotherapy in 2005 when she was diagnosed with breast cancer. Adrienne said: “I put a brave face on but the effects of chemotherapy, which for me included diarrhoea, constipation and mouth infections, were awful. I remember sitting in hospital being injected with bright pink liquid and thinking, ‘what is this doing to my body?’ Luckily I had a very supportive husband but it felt like a whole year had been taken from me whist I underwent chemotherapy. It is remarkable to think a genomic test could determine who will benefit from going through chemotherapy and who may not.”

Adrienne, who is a trustee of the Independent Cancer Patients' Voice charity, helped design the initial feasibility phase of the trial whilst under the care of Professor Stein. Adrienne said: “It was a big ask to request patients accept the results of a genetic test to determine whether or not they have a treatment that is currently routine. I had long discussions with my friends, family and colleagues and decided it is such an important trial that it was worth the big ask.”

Melody McClaren, a writer originally from California who lives in Potters Bar, lost her mother and grandmother to breast cancer. In 2014 Melody, then aged 57, was diagnosed with breast cancer and underwent five cycles of chemotherapy. Melody said: “I experienced nausea and fatigue and the anti-nausea drugs made me feel even sicker.  Pain in my joints also forced me to abandon playing the piano and playing volleyball, which I used to really enjoy.”

Melody participated in the initial feasibility study of the trial. Melody said: “My own reasoning for taking part was less about personal benefit and more about realising that in order for genetic screening to potentially become part of normal NHS practice, trials would be needed to accumulate the necessary evidence.”

Similar genomic tests are already used within the NHS and tissue samples are sent overseas for testing. In the OPTIMA trial the UCL Advanced Diagnostics lab, based on University Street, will perform Prosigna testing.

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

The trial has been awarded £5.33m by the NIHR Health Technology Assessment (HTA) programme (project numbers 10/34/01 and 10/34/501) 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.

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