A patient at The Christie NHS Foundation Trust in Manchester has benefited from a ground-breaking clinical trial that could spare thousands of women with breast cancer from having unnecessary chemotherapy each year.
Many patients with the common hormone-driven type of cancer don’t benefit from chemotherapy and are being exposed to needless treatment. The dilemma is knowing who could benefit from chemotherapy and who can be safely spared.
Aileen Pritchard, 62, who owns Manchester-based Smart Alex, a dry cleaning and laundry business with her husband Kevin, has been clear of cancer for 4 years without having chemotherapy to treat her breast cancer thanks to a new test being trialled at The Christie NHS Foundation Trust.
In July 2018, Aileen, who has 3 daughters and has always been fit and healthy, felt a lump in her right breast. She went to her GP who referred her for a scan which showed she had a 7.2cm tumour and was diagnosed with stage 3 breast cancer and underwent a mastectomy a few weeks later.
In October 2018 Aileen, who lives in Darwen in Lancashire, was referred to The Christie for radiotherapy where she was given the option of taking part in a clinical trial called OPTIMA (Optimal Personalised Treatment of early breast cancer using Multi-parameter Analysis). The trial aims to reduce the number of patients with breast cancer who are given chemotherapy unnecessarily. The study is designed for patients where the cancer has spread to up to 9 lymph nodes, therefore a higher risk of the disease spreading.
Because Aileen’s cancer had spread to a lymph node under her arm, she was suitable for the study and randomised to the group that had the Prosigna test. Aileen’s test result showed a low score indicating chemotherapy wasn’t needed. She was given a course of radiotherapy and is now in remission.
Dr Anne Armstrong, consultant oncologist who is leading on the OPTIMA trial at The Christie said: “To have a test that can tell us who can be spared chemotherapy is very exciting. Although it can’t help all breast cancer patients, it could, in the future, be extremely beneficial to patients like Aileen with the hormone-driven type of the disease. If the Prosigna test was approved to be routinely used, it may be able to reduce the use of chemotherapy without having any effect on rates of successful treatment.
“This is another example of how we’re moving towards more targeted and personalised treatments, meaning patients aren’t unnecessarily exposed to the toxicity of chemotherapy. We are still recruiting patients with breast cancer to the OPTIMA clinical trial from across the UK. We hope that once results are published this could lead to a change of practice for around 10% of women diagnosed with breast cancer each year.”
OPTIMA research nurse at The Christie, Molly Newman added: “We worked hard to ensure recruitment to the OPTIMA trial didn’t slow down during the pandemic to enable as many patients as possible to avoid chemotherapy, which would weaken their immune system and leave them more susceptible to the symptoms caused by contracting COVID-19. It also helped reduce the number of patients going for chemotherapy, which helped the department during this particularly challenging time.”
Talking about being on the OPTIMA clinical trial, Aileen, who was able to carry on working throughout her treatment, said: “There were 2 reasons I said yes to the trial. I was not looking forward to chemotherapy, so the slightest chance of not having it was good news. I don’t take drugs unless I really have to, so to avoid any treatment that isn’t necessary is a real bonus for any patient like me.
"I also wanted to do something to help other women. If the results can help other people’s treatment in the future then I‘m all for that. I’m so glad I took part in the clinical trial and would encourage other patients in my position to do so. I’ve felt fit and well throughout. I’ve had the mindset that having cancer wouldn’t impact on me and I’ve been determined to keep a positive outlook.”
Left to right: Aileen and her husband Kevin
The study, led by UCL and UCLH (University College London Hospitals NHS Foundation Trust), is looking at the use of a molecular test to determine which patients need chemotherapy. It has recruited more than 3,000 patients so far across the UK, Sweden and Norway, and is looking to recruit a further 1,500 before recruitment is complete by the end of 2024.
So far, about two thirds of patients tested in the trial have avoided chemotherapy. The trial could benefit around 5,600 to 5,800 people diagnosed with breast cancer annually in the UK if approved by The National Institute for Health and Care Excellence (NICE), once the results of the study are published.
For half a century, doctors have made decisions about chemotherapy based on simple factors such as the size of the cancer, if it has spread to nearby lymph nodes and what it looks like under a microscope. But this is seen as a relatively crude way of determining which patients receive it. Chemotherapy carries risks and can lead to a number of unpleasant short and long- term side effects such as fatigue, nausea and neuropathy. Some patients will do just as well with hormone tablets alone and could benefit by getting on them more quickly.
Over the past few years, laboratory scientists across the world have developed new tests which probe the deep biology of the breast cancer, far beyond what can be seen with a microscope. This new technology is transforming the way we think about this disease and the evidence is stacking up to suggest that it can pick out patients who need chemotherapy, and therefore also identify those patients who would get no benefit from this treatment.
NICE (The National Institute for Health and Care Excellence) considers the use of tests may be effective for patients whose cancer has spread to under-arm (axillary) lymph nodes, and has recommended more research in this area, which is what the OPTIMA study is doing. The Prosigna test uses a specialist machine to look at a sample of breast cancer tissue. The sample is taken from tissue removed when you had a biopsy or surgery. The test looks at 50 genes in the cancer cells and how they work.
OPTIMA is funded through the National Institute for Health Research (NIHR) Health Technology Assessment Programme.
The study is expected to complete recruitment at the end of 2024.
Any patients interested in taking part in clinical trials should discuss this option with their consultant or GP. Not all patients will fit the criteria for a specific trial. While clinical trials can be successful for some patients, outcomes can vary from case to case.