Trial success helps patients avoid radical bladder cancer surgery

Wendy Powell took part in the early clinical trial

Last week we reported on the success of a major bladder cancer trial, funded by Cancer Research UK.

The practice-changing trial will mean that, in future, fewer of the thousands of patients diagnosed with the disease each year will need their bladder removed, and, in some cases, their womb and ovaries or prostate and urethra too (since these are the areas where the cancer is most likely to return).

Removing the bladder is a major operation with implications for the rest of a patient’s life. As the disease is linked to smoking and around eight out of ten cases diagnosed in patients over 65, some patients are in relatively poor general health when diagnosed and so unable to cope with such radical surgery.

Until recently the only alternative has been radiotherapy. But around a third of patients given radiotherapy eventually relapse with invasive disease and so need to have their bladder removed anyway.

To try to improve things, researchers based at the University of Birmingham and The Institute for Cancer Research in Sutton, funded by Cancer Research UK, have been looking for better alternatives.

Low-dose chemotherapy

They’ve been investigating whether low doses of chemotherapy during radiotherapy (called chemoradiotherapy ) to sensitise the cancer cells to treatment can help improve things. A similar approach has already revolutionised treatment for anal cancer.

There were some concerns that combining radiotherapy and chemo might add to the side effects, but an earlier phase I/II trial involving 41 patients with invasive bladder cancer suggested otherwise.

These 41 patients were among the first bladder cancer patients in the world to trial chemoradiotherapy. They each received two commonly used chemotherapy drugs – fluorouracil and mitomycin C – in addition to radiotherapy treatment.

Wendy Powell, 49, from Birmingham was one of these patients. She had persistent symptoms of cystitis, and was treated with antibiotics. But over time, she told us, “it got worse and worse”.

“I had some tests and was sent home. I was having difficulty passing anything and people were saying that it could be my age, but my GP wasn’t happy and I was sent to urology,” she told us.

When they did the tests they found a tumour in her bladder the size of a lemon.

The study hit the headlines

“When I was told it was cancer, it was a shock at first. They went through the options for treatment and mentioned the trial. You just think about getting well and I gave permission to try it. I was keen to get rid of the tumour. You put your life in their hands and the outcome has been good – it is 13 years next month. I can’t believe it”.

On the trial, she did experience some side-effects. “It is bad going through that, as they are strong treatments. There are times when you cannot see the light at the end of the tunnel, but you get there and you have to see that it is going to make you well.”

Each year over 30,000 people take part in trials funded by Cancer Research UK. And it’s thanks to people like Wendy that we are able to continue this lifesaving work. She added:

“I feel I am lucky that it did all work. I did have side-effects and it has all been a hard journey but it is worth it.

“I have had regular cystoscopies since and am all clear again. I have a cancer clinic appointment once a year.

She’s back to normal now and glad she helped make a difference. “I am all for trials. It is really good they are coming up with new things.

Larger trial

The success of the trial meant that the treatment could progress on to a larger phase III randomised trial – funded by Cancer Research UK – the results of which are published in the New England Journal of Medicine.

Three hundred and sixty patients from around the UK took part, around half of which received chemoradiotherapy and the remainder of which had the standard radiotherapy treatment.

The results are “hugely promising”, Professor Nick James from the University of Birmingham, who ran the trial alongside Dr Robert Huddart from The Institute for Cancer Research, told us.

Among those who had chemoradiotherapy, around 33 per cent had a relapse in their bladder or the surrounding tissues within two years, compared to 46 per cent in the group that had radiotherapy alone (a reduction of around a third).

And when the team looked at the risk of potentially lethal invasive cancer returning, the improvement was even more marked. People who were only given radiotherapy were about twice as likely to relapse with invasive disease than those who had chemoradiotherapy.

Early results also showed chemoradiotherapy 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. But larger studies will be needed to confirm this.

“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 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,” Kate Law, director of clinical research at Cancer Research UK, told us.

And as well as showing how clinical trials can improve things, this story demonstrates that, alongside the excitement about new, personalised therapies, sometimes new combinations of existing treatments can have just as much of an impact on patients’ lives.

Ailsa

For more information about this trial and others, please visit CancerHelp UK or call the Cancer Research UK cancer information nurses on 0808 800 4040.

Reference:

James, N. et al (2012). Radiotherapy with or without Chemotherapy in Muscle-Invasive Bladder Cancer New England Journal of Medicine, 366 (16), 1477-1488 DOI: 10.1056/NEJMoa1106106