The trial – led by scientists at the University of Birmingham, and the Institute of Cancer Research (ICR) – is the largest of its kind in bladder cancer in the world. Its success could mean fewer patients with invasive bladder cancer will need radical surgery to completely remove their bladder.
The results will be presented at the American Society for Radiation Oncology (ASTRO) annual conference next Monday (1st November 2010)*.
Professor Nick James, from the University of Birmingham, who led the study with Dr Robert Huddart from the ICR, said: “These trial results are hugely promising, with a significant reduction in the risk of the cancer returning when compared to radiotherapy alone. When we looked at the risk of potentially lethal invasive disease returning, the improvement was even more marked.”
After two years of follow up the results showed a tumour relapse rate of 33 per cent for patients receiving chemotherapy in addition to radiotherapy – known as chemoradiotherapy – compared to 46 per cent for radiotherapy alone. The reduction in relapse of the most severe type of tumour was even more marked at 18 per cent versus 32 per cent percent.
Professor James added: “Importantly, both chemotherapies used in this trial are cheap widely available drugs that are commonly used in cancer treatment already. This makes their use much more practical.
“Having surgery to remove the bladder is a major operation that can seriously impact a patient’s quality of life. We have shown that adding chemotherapy to radiotherapy reduces the risk of the most severe type of tumour recurring by nearly half. Hopefully these trial results will mean more bladder cancer patients are given the opportunity to avoid surgery and preserve their bladder function.”
Patients diagnosed with invasive bladder cancer are usually offered either radiotherapy alone – which carries a 40 to 50 per cent chance of the cancer coming back – or surgery to completely remove the bladder.
But giving the two chemotherapy drugs – 5FU and Mitomycin C – at the same time as the radiotherapy helped make the cancer cells more sensitive to it, boosting the effectiveness of the treatment.
The new approach could lead to fewer invasive bladder cancer patients being referred for surgery and may provide a lifeline for those too old or weak to survive the operation.
Each year in the UK around 10,300 people are diagnosed with bladder cancer. It is responsible for more than 4,900 deaths per year, primarily in older people, and is the fourth most common cancer in men.
Kate Law, director of clinical research at Cancer Research UK, said: “The results of this promising trial offer patients a potentially effective option for those who want to avoid having their bladder removed.
“This is particularly important since eight out of ten cases of bladder cancer occur in patients over 65, meaning many patients are unsuitable for surgery due to their age or other pre-existing health conditions.
“This trial demonstrates that efforts to maximise the effectiveness of radiotherapy and chemotherapies are vital. These treatments remain a crucial part of the fight against the disease.”
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Notes to editors
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.
All of these 360 patients received radiotherapy and half were randomly chosen to receive the chemotherapy drugs 5 Fluorouracil (5-FU) and Mitomycin C alongside their radiotherapy.
This work was supported by Cancer Research UK (CRUK/01/004) and the trial was co-ordinated by the Cancer Research Clinical Trials Unit (CRCTU) at the University of Birmingham (C547/A2606; C547/A6845; C9764/A9904) and the Cancer Research UK funded Clinical Trials and Statistics Unit at The Institute of Cancer Research (ICR-CTSU) (C1491/A9895).
For further information visit our patient information website, CancerHelp UK.
About bladder cancer
- Bladder cancer is the seventh most common cancer in the UK.
- Each year in the UK around 10,300 people are diagnosed with bladder cancer.
- Bladder cancer is the fourth most common cancer in UK men, with more than 7,300 new cases each year. There are more than twice as many cases in men as in women.
- Each year in the UK, around 4,900 people die from bladder cancer.
- Almost nine in ten deaths from bladder cancer are in people over 65.
- Since peaking in the early 1990s, the bladder cancer death rate in men has decreased by more than a third.
- Invasive bladder cancer means that the cancer cells have spread beyond the inner lining and into the muscle layer of the bladder.
For more information about bladder cancer visit CancerHelp UK.