This is the first in a new series highlighting innovative work led by Tessa Jowell Centres of Excellence to improve the quality of treatment and care for people with a brain tumour. These projects are funded by other organisations and led by clinicians at designated Tessa Jowell Centres of Excellence. Please contact us if you would like a project you are running to be featured.
About the SAFER study
Given the poor prognosis of many brain tumours and the limited treatment options available, many research projects rightly focus on finding newer, and kinder, treatments. But research can also improve patients’ lives in other ways – such as by giving clinicians better evidence to guide decisions about what people can safely do during and after treatment.
The SAFER study, led by Dr Nicola Rosenfelder, Consultant Clinical Oncologist at The Royal Marsden NHS Foundation Trust, is a good example of the latter category.
SAFER is part of a wider programme of research into seizure risk in people with brain metastases treated with stereotactic radiosurgery (SRS, a targeted form of radiotherapy) at The Royal Marsden, which forms part of the St George’s, Royal Marsden and Royal Surrey Tessa Jowell Centre of Excellence. The study is funded by the NIHR Biomedical Research Centre at The Royal Marsden and the Institute for Cancer Research (ICR).
Driving after radiotherapy to the brain
For many people with neurological conditions such as a brain tumour, diagnosis and treatment can mean having to stop driving. This includes almost all patients with brain metastases, who will generally have their licence suspended for one to two years.
That can be a major change, particularly for people who rely on driving for work or live in areas with limited public transport. It can add to the practical and psychological burden of a brain tumour diagnosis and reduce independence.
Decisions about who can and cannot drive are made by the Driver and Vehicle Licensing Agency (DVLA), which bases its guidance on the risk of a sudden event, such as a seizure, affecting someone’s ability to drive safely. For Group 1 licences, held by most car and motorcycle drivers, an estimated annual seizure risk of 20% is the threshold at which a licence is withdrawn.
Any patient diagnosed with brain metastases is at some risk of seizures, even if they have no symptoms. The challenge is that much of the evidence used to estimate that risk comes from older retrospective studies, including some from before SRS or even magnetic resonance imaging (MRI) became widely used.
Early studies reported seizure rates ranging from 21% to 67%. More recent studies have generally reported lower rates. One large analysis found seizure incidence of around 10% to 11.6%, while other work has suggested that risk varies between different groups of patients. The varying nature of these data raises a key question: are some people at sufficiently low risk that they could safely return to driving sooner?
Project lead, Dr Nicola Rosenfelder, Consultant Clinical Oncologist at the Royal Marsden
Building the evidence base
SAFER was set up to provide stronger evidence to answer that question. It is the first prospective study to examine seizures as a primary outcome in patients with brain metastases undergoing SRS. The study aims to recruit 375 patients and assess how often seizures occur after treatment, as well as which clinical factors might identify people at higher or lower risk.
The first results have now been published in Clinical Oncology: Seizure Risk in Patients With Brain Metastases: Interim Analysis From a Prospective Observational Study. Is it Time to Review Driving Policy?
The interim analysis included the first 75 patients recruited to the study. Eight experienced a seizure within 12 months of SRS, giving an overall seizure rate of 10.7%. Among patients who had not experienced a seizure before SRS, the new-onset seizure rate was 9.2%.
The observed risk also appeared to fall over time. Among patients who remained seizure-free at six months, 5.8% experienced a seizure before 12 months, while no new seizures were observed between nine and 12 months.
These are interim findings from a relatively small group of patients, and the researchers are clear that longer follow-up and the full study population will be needed before firm conclusions can be drawn.
The longer-term aim is to use data from all 375 participants to develop a risk-stratification approach for people with brain metastases following SRS. If that proves possible, it could help inform future guidance on when individual patients may be able to return to driving safely.
Helping people live better with cancer
Research like SAFER is important because decisions about driving have a tangible effect on daily life. Better evidence could help the DVLA and clinicians make future guidance as proportionate as possible, while maintaining safety.
This is also an important part of what the Tessa Jowell Brain Cancer Mission means by improving brain tumour care. Tessa Jowell Centres of Excellence are recognised not only for the quality of their treatment and research, but for the care provided across the whole multidisciplinary team and for work that improves patients’ quality of life.
Better treatments remain urgently needed. But so does research into the everyday consequences of living with and being treated for a brain tumour, including rehabilitation, cognition, fatigue, work and independence.
If SAFER can ultimately help identify patients who can safely return to driving sooner, that could make a meaningful difference to people’s lives.
