Wednesday 18 April 2012
Bladder cancer patients given low doses of chemotherapy combined with radiotherapy were nearly 50 per cent less likely to relapse with the most lethal form of the disease compared to patients given radiotherapy alone, a major trial funded by Cancer Research UK shows today (Wednesday).
The success of the trial – led by The Institute of Cancer Research (ICR) and the University of Birmingham – could mean fewer patients need their bladder removed and provides a viable alternative for frailer patients who are too weak for surgery.
The results are published in the New England Journal of Medicine today.
Study co-leader Professor Nick James from the University of Birmingham said: “Many cases of bladder cancer are related to smoking and, with around eight out of ten cases occurring in people over 65, patients are often in relatively poor general health when diagnosed.
“Removing the bladder is still one of the most effective treatments for invasive cancer that has spread into the muscle of the bladder. But in practice we know many patients are too frail for such radical surgery.
“The alternative is to give radiotherapy, but around a third of these patients will go on to relapse with invasive disease and will need their bladder removed anyway. So these results really provide a lifeline for those too old or weak for surgery and mean that, in future, fewer patients will need their bladder removed.”
Three hundred and sixty patients from around the UK were included in the study. Around half were given two commonly used chemotherapy drugs – fluorouracil and mitomycin C – in addition to the radiotherapy treatment.
Thirty three per cent of patients receiving chemotherapy in addition to radiotherapy (known as chemoradiotherapy) had a relapse within their bladder or surrounding tissues within two years, compared to 46 per cent of those who had radiotherapy alone.
Of those who received chemoradiotherapy, around one in five developed invasive cancer – the most serious form of the disease – compared to around one in three among those who had radiotherapy alone.
Early results also showed that combining radiotherapy with chemotherapy may improve survival, with 48 per cent of patients still alive after five years, compared to 35 per cent of those who had radiotherapy alone, although larger studies are needed to confirm this.
Study co-leader Dr Robert Huddart from the ICR and The Royal Marsden NHS Foundation Trust, added: “Removing the bladder is a major operation with implications for the rest of the patient’s life. We found that adding chemotherapy to radiotherapy successfully lowered the risk of relapse sufficiently to make it a real option for patients who don’t wish to have radical surgery and lose their bladder. Importantly, these improvements have been achieved with drugs that are cheap and widely available, and carry few additional side-effects over radiotherapy alone.”
Wendy Powell is 49-years-old and lives in Birmingham. She agreed to take part in an earlier pilot study after tests 13 years ago revealed a tumour in her bladder “the size of a lemon”.
She said: "When I was told I had bladder cancer it was a shock at first. They went through all the options for treatment and when they mentioned the trial I decided to give it a try. I did have side-effects and it has all been a hard journey, but in the end it’s been worth it because here I am thirteen years later. I'm back to normal now and it's thanks to clinical trials that more people are surviving like me. I'm all for trials. It's really good they're coming up with new ways of treating the disease."
Each year in the UK around 10,400* people are diagnosed with bladder cancer. It is responsible for around 5,000** deaths per year. Bladder cancer is most common in older people, and is the seventh most common cancer in the UK.
Kate Law, director of clinical research at Cancer Research UK, said: “These findings provide a new ‘gold standard’ of treatment that will be particularly important for elderly patients, because surgery to remove the bladder in this age group can have a particularly severe impact on quality of life.
“Survival rates for bladder cancer have been increasing in recent years, with around half of patients now surviving 10 years or more, compared to around a third in the 1970s. But bladder cancer is largely a disease of older people and, with an ever ageing population, it’s essential that there are alternative treatments suitable for this age group.”
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For media enquiries, please contact Ailsa Stevens in the Cancer Research UK press office on 020 3469 8309 or, out of hours, 07050 264 059.
Notes to editors:
Nicholas D. James et al, Radiotherapy with or without chemotherapy in muscle-invasive bladder cancer (2012), New England Journal of Medicine, DOI: 10.1056/NEJMoa1106106.
* Annual average number of cases 2006-2008
**Annual average number of deaths 2007-2009
About the BC2001 trial
The BC2001 trial was a randomized multi-centre trial looking at radiotherapy with or without chemotherapy for people with invasive bladder cancer.
The UK-wide trial involved 458 patients. It investigated the addition of chemotherapy to radiotherapy (known as chemoradiotherapy), as well as two different ways of giving radiotherapy. 360 patients were included in the study that looked at chemoradiotherapy, making it the largest study of this type of treatment of bladder cancer in the world to date.
The trial was co-ordinated by The Institute of Cancer Research’s Clinical Trials and Statistics Unit (ICR-CTSU) and the Cancer Research UK Clinical Trials Unit (CRCTU) at the University of Birmingham.
Professor Nicholas James worked with co-author Dr Syed Hussain from the University of Liverpool to set up and run the BC2001 trial, as well as early phase trials that served as the foundation for this study.
For more information see: http://cancerhelp.cancerresearchuk.org/trials/a-trial-looking-at-radiotherapy-with-or-without-chemotherapy-for-people-with-bladder-cancer
About the University of Birmingham
- The University of Birmingham is a truly vibrant, global community and an internationally-renowned institution. Ranked among the world's top 100 HE institutions, its work brings people from across the world to Birmingham, including researchers and teachers and more than 4,000 international students from nearly 150 countries.
- The University is home to nearly 30,000 students. With more than 7,500 postgraduate students from across the world, Birmingham is one of the most popular universities for postgraduate study in the UK.
- The University plays an integral role in the economic, social and cultural growth of local and regional communities; working closely with businesses and organisations, employing approximately 6,000 staff and providing 10,000 graduates annually.
About The Institute of Cancer Research
The Institute of Cancer Research (ICR) is one of the world’s most influential cancer research institutes.
Scientists and clinicians at the ICR are working every day to make a real impact on cancer patients’ lives. Through its unique partnership with The Royal Marsden Hospital and ‘bench-to-bedside’ approach, the ICR is able to create and deliver results in a way that other institutions cannot. Together the two organisations are rated in the top four cancer centres globally.
The ICR has an outstanding record of achievement dating back more than 100 years. It provided the first convincing evidence that DNA damage is the basic cause of cancer, laying the foundation for the now universally accepted idea that cancer is a genetic disease. Today it leads the world at isolating cancer-related genes and discovering new targeted drugs for personalised cancer treatment.
As a college of the University of London, the ICR provides postgraduate higher education of international distinction. It has charitable status and relies on support from partner organisations, charities and the general public.
The ICR’s mission is to make the discoveries that defeat cancer. For more information visit www.icr.ac.uk
About Cancer Research UK
- Cancer Research UK is the world’s leading cancer charity dedicated to saving lives through research
- The charity’s groundbreaking work into the prevention, diagnosis and treatment of cancer has helped save millions of lives. This work is funded entirely by the public.
- Cancer Research UK has been at the heart of the progress that has already seen survival rates in the UK double in the last forty years.
- Cancer Research UK supports research into all aspects of cancer through the work of over 4,000 scientists, doctors and nurses.
- Together with its partners and supporters, Cancer Research UK's vision is to beat cancer.
For further information about Cancer Research UK's work or to find out how to support the charity, please call 0300 123 1861 or visit www.cancerresearchuk.org