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

Lots in the news this week

• A major Cancer Research UK study published this week could revolutionise the way women with breast cancer are diagnosed and treated in the future. It reclassifies the disease into 10 completely new categories based on their genetic make-up. We’ve got an extensive analysis of the paper on the blog. And watch our chief executive Harpal Kumar and study leader Carlos Caldas talk about the implications of the study.

• Another big study funded by us – this time a bladder cancer trial – showed that patients given low doses of chemotherapy with radiotherapy are nearly 50 per cent less likely to relapse with the most lethal form of the disease compared to those given radiotherapy alone. This could mean fewer patients need their bladder removed and provides an alternative for frailer patients who are too weak for surgery.

• The government launched a public consultation on plain packaging of cigarettes on Monday. The idea is to standardise all packaging to ensure children are protected from the ‘silent salesman’ of branded packs, and give them one less reason to start smoking. A YouGov poll found strong public support for the policy. The BBC has a nice video feature about the consultation.

• An experimental sound-wave treatment for certain types of prostate cancer may have fewer side effects than current therapies, according to new UK research published on Tuesday. It’s fascinating and encouraging research, but we’ll have to wait for the results of much larger trials before current clinical practice is changed.

• We launched a new partnership with the Royal Collage of GPs to improve cancer diagnosis and care in general practice. The programme aims to develop ways to help doctors confidently diagnose more cancers at an earlier stage, which should save more lives from the disease.

• Bringing in a minimum price of 40 pence per unit of alcohol could cut deaths and hospital admissions, according to a UK economist. We know that about 12,500 cases of cancer in 2010 were down to alcohol, so welcome the introduction of minimum pricing as part of a wider strategy to reduce the consumption of alcohol and help prevent cancer.

• A new ‘nanoparticle’-based imaging technique could improve the accuracy of brain tumour surgery, according to lab work by US scientists.

• A team of Cancer Research UK scientists at UCL showed that increasing pressure ejects surplus healthy cells from overcrowded tissues, revealing a possible link between this process and the spread of cancer. Dr Kat Arney talked with the Huffington Post about the work.
• And finally, congratulations to Prof Shankar Balasubramanian at our Cambridge Research Insitute, Prof Tony Kouzarides at The Gurdon Institute, and Dr Julian Lewis at our London Research Institute – who have all been elected as fellows of the Royal Society.

Clinical trials are crucial in cancer research

Since 1995, more than 100,000 patients have taken part in our treatment trials.

In this final article selected from our Annual Review, we focus on the crucial role of clinical trials and the people who take part in them.

Without clinical trials, and the volunteers who take part in them, our groundbreaking research would not be possible. They are a vital part of developing new ways to prevent, detect and treat cancer, improving the quality of life for cancer patients and helping more people to survive the disease.

This year, abiraterone, a drug for advanced prostate cancer which was first discovered and developed by our scientists, reached a landmark stage of development. Results from a large trial involving nearly 1,200 men showed that this treatment can provide patients with valuable extra months of life. This could make a huge difference to the 10,000 men diagnosed with aggressive forms of the disease in the UK every year.

We hope this drug will be available to prostate cancer patients by early 2012. We’re now funding a trial to find out whether abiraterone can help treat breast cancer.

We also had results from a major bladder cancer trial, which showed that adding two commonly-used chemotherapy drugs to traditional radiotherapy can reduce the chance of a patient’s tumour coming back by a third. The trial was the largest of its kind in bladder cancer in the world. This treatment could mean fewer patients with invasive bladder cancer will need radical surgery to completely remove their bladder.

‘I’m delighted to have contributed to research into the treatment of cancer. The medics and researchers do the hard work but I’m pleased I could put their efforts into practice and test these new treatments.’

- John Condor, retired Royal Navy Serviceman and patient, on a clinical trial in Southampton

‘I’m taking part in trials for a treatment called taxol and another that monitors my blood every month. I wanted to try and help someone else, even if the trial doesn’t help me. We’ll never get to the bottom of these diseases without clinical trials and we need to have hope. I get through it because I live life for today.’

- Rita Negus, 63, Cambridge, has had ovarian cancer since 2006 and is taking part in two clinical trials

Frequently asked questions

We fund around 200 cancer trials nurses at hospitals throughout the UK, who help to give treatments and care for people taking part in trials

Here, Anne Croudass, one of our research nurses, answers some frequently-asked questions about this part of our life-saving research.

What are clinical trials?

All new cancer treatments and ways to prevent or detect the disease have to be thoroughly tested before they are licensed and available for patients. Something might look promising in the lab, but we won’t yet know if it will help people with cancer. Clinical trials aim to find out if new treatments and tests are safe, if they have side effects and if they work better than the approach currently used. Year on year, clinical trials help to refine and improve existing ways of diagnosing or treating people with cancer, and save lives.

How many people take part?

We fund clinical trials in hundreds of towns and cities across the UK, with some recruiting patients in as many as 100 different hospitals. Last year, 31,000 people joined a trial supported by Cancer Research UK – that’s three-quarters of all people taking part in UK cancer trials.

Our CancerHelp UK website includes a unique searchable database of UK cancer clinical trials, written in plain English specifically for patients and relatives.

Why are they so important?

We rely on people taking part in clinical trials to make progress in our fight against cancer. They provide the evidence we need to improve clinical care for cancer patients in the future. Many thousands of people have survived cancer as a result of treatments and screening approaches that we have developed or tested. Our trials have led to improvements in cancer diagnosis and care for many different types of cancer including breast, bowel, lung, skin, prostate and pancreas.

We funded the largest ever trial for people with operable pancreatic cancer. This showed that giving chemotherapy to patients after surgery could extend the lives of people with the disease – this is now standard practice worldwide. We also funded pivotal clinical trials that have shaped the way tamoxifen is used to treat breast cancer today.

What happens after a trial?

Trials can go on for several years after a patient has stopped treatment, as our researchers need to monitor the long-term effects.

Going for a swim won't give you cancer

“Swimming too often in chlorinated water ‘could increase risk of developing bladder cancer’, claim scientists”.

But did they, or is this another example of misreporting cancer research by the media?

Unfortunately, it’s the latter. This is an example of poor reporting, which makes unwarranted claims about human health. The research itself says nothing new about bladder cancer, and didn’t even involve people with the disease.

Let’s have a look at what’s going on.

The story came from research carried out by a Spanish team, led by Dr Gemma Castaño-Vinyals, which is investigating the possible effects of man-made chemicals on cancer rates in the region. For this study, the researchers tried to find out whether people from different social classes and backgrounds might have different levels of exposure.

Their findings, which were published in the journal ‘Environmental Health’ (not, as the newspaper claimed, ‘BioMed Central’), is freely available to download – you can read it here (pdf) and here’s the accompanying press release (Word).

What does the research say?

The paper describes how the researchers re-analysed data from a study called the Spanish Bladder Cancer case-control study, which was carried out during 1998 – 2001. As part of this study, 1,271 people without bladder cancer were interviewed about a variety of their habits and behaviours – this was to compare them to people with bladder cancer as a ‘control’ group.

The new study looked at the information recorded about these ‘control’ subjects, in particular whether they had said they drank tap or bottled water, how often they said they showered or took baths, and how often they remembered going to the swimming pool. It also looked at the information on their social background and where they lived.

Next, the researchers asked water companies around Spain for data from the same period, about the levels of certain types of by-product from the disinfection process called trihalomethanes (THMs). They also measured levels of these chemicals themselves. This allowed them to make a rough estimate of how much THM people might have been exposed to over the study period.

Finally they did some stats – they looked at the relationship between estimated THM exposure and people’s social background. They concluded:

The most highly educated subjects were less exposed to chlorination by-products through ingestion, but more exposed through [skin] contact and inhalation in pools and showers/baths. Health risk perceptions and economic capacity may affect patterns of water consumption that can result in differences in exposure to water contaminants.

The results didn’t say anything about at difference in bladder cancer risk between the different social groups, it merely proposed that different people behave differently with respect to how they use water.

Do THMs affect human health?

Several studies and organisations have looked at whether substances we add to water to stop bacteria growing it might be inadvertently harming us. It’s fair to say that there’s some evidence of a possible risk, but other studies that don’t show an effect. More importantly there’s no hard evidence of a ‘smoking gun’ – if these chemicals do have any effect, it’s likely to be very small.

The World Health Organisation’s recommendations on drinking water conclude that:

The use of chemical disinfectants in water treatment usually results in the formation of chemical by-products. However, the risks to health from these by-products are extremely small in comparison with the risks associated with inadequate disinfection, and it is important that disinfection not be compromised in attempting to control such by-products.

The UK’s Drinking Water Inspectorate has also published a comprehensive analysis (pdf). It too concludes that there’s very little good quality data on the health effects of THMs, and that the guidelines that do exist are ‘highly precautionary’ – i.e. they are almost  certainly sufficient to protect our health, given what we currently know.

So given the scientific consensus that these chemicals probably aren’t significantly affecting our health, it’s somewhat unfortunate that a national newspaper chose to highlight that they are, despite any new research to the contrary.

And if a thorough review of the evidence concludes that the science isn’t strong enough yet to assess any risks, it certainly isn’t strong enough to justify a scary headline.

So what does cause bladder cancer?

By far the biggest risk factor for bladder cancer – as for so many types of cancer – is tobacco, which causes about two thirds of cases.

There’s also evidence that people who work with high concentrations of certain chemicals such as dyes, for long periods of time may have an increased risk. There’s more detailed information about what is known about the causes of bladder cancer in the CancerStats section of our website.

And what about water?

In developed countries such as the UK, we have extremely strict standards and regulations governing what can and can’t be present in the water we drink and bathe in. It’s fair to say that our water is the safest it’s ever been – especially as far as cancer is concerned.

There have, of course, been persistent myths and rumours about possible contaminations from the plastic bottles many of us use to drink from – and headlines like the ones in the papers this week do nothing to dampen down these concerns.

At Cancer Research UK we do our best to provide you with the latest evidence on what causes cancer – and what doesn’t. You can read more about this in the Cancer Controversies section of our website. Next time you see an alarming headline in the media, it’s always worth popping by to find out what the science really says.

Henry

Reference:

Castano-Vinyals, G., Cantor, K., Villanueva, C., Tardon, A., Garcia-Closas, R., Serra, C., Carrato, A., Malats, N., Rothman, N., Silverman, D., & Kogevinas, M. (2011). Socioeconomic status and exposure to disinfection by-products in drinking water in Spain Environmental Health, 10 (1) DOI: 10.1186/1476-069X-10-18

• Image from Wikimedia Commons