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UK: New Cancer Trial That Offers Hope


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http://www.guardian.co.uk/society/2008/ ... lth.cancer


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The new cancer trial that offers hope to thousandsAcross the country 800 terminally ill men and women have agreed to be human guinea pigs in a hunt for new cancer drugs. Here, for the first time, patients and doctors tell Denis Campbell about the medical revolution that offers hope and helps speed the discovery of new treatments

Cancer statistics are brutal. Every year 285,000 people are diagnosed with the disease in the UK and more than 150,000 die from it. About two million are either living with cancer or have survived it. Each of us has just over a one in three chance of developing one of the 200-plus forms of cancer.

But among the many sufferers with terminal cancer, 782 men and women have that most precious commodity - hope. Conventional NHS cancer treatments such as chemotherapy and radiotherapy have failed them. They have nothing left to try. So they have volunteered to take part in clinical trials of unlicensed, experimental cancer drugs. With luck, these novel treatments may extend their lives. They will certainly help ensure that future generations of cancer patients can have better treatments that should prolong theirs.

At worst, though, these potential life-savers could also kill them earlier than their cancer would, because of their toxicity.

These 782 individuals, from every corner of the UK, are participating in 289 trials covering dozens of forms of cancer that are being undertaken at 19 experimental cancer medicine (ECM) centres, in places including Belfast, Edinburgh, Newcastle, Cardiff and London. Almost 200 scientists, doctors and nurses in the centres are devoting their energies to the pursuit of innovative, more effective cancer drugs.

'It would be wrong to portray experimental cancer medicines as dolly mixtures that will cure everyone. They're not,' said Professor Herbie Newell, who co-ordinates the 19 centres. 'However, they are exciting new treatments, which are targeting the lesions that cause cancer. Patients in experimental trials help us bring the new treatments to the stage where they can be evaluated for licensing for widespread clinical use. That could potentially help tens of thousands of patients in the future.'

The brave, unacknowledged efforts of these 782 patients have already helped scientists produce new drugs that work in cancers that were previously hard to treat, allowing people to extend their lives and spend a few more months or even years with their loved ones.

Newell works for Cancer Research UK, which set up the experimental network in April 2007 with the Department of Health. The Observer has been given unprecedented access to the five-year, £35m research programme which is helping to revolutionise the treatment of cancer in the UK. For the first time, patients involved in the trials have talked about their experiences, good and bad, and the doctors about their struggle against a disease that is one of the nation's biggest killers.

An ECM treatment is a last chance. It brings hope to the otherwise hopeless. Places in the trials are only for those whose NHS treatment has not worked or has stopped working, as cancer drugs often do after a short time. Volunteers also have to be well enough to be involved and happy to take part, usually for several months at a time. Unlike many other trials, there is no payment. Several thousand people apply each year, but only a handful get in. All desperately want to be among the lucky few whose tumours shrink or stop growing, extending their lives.

'In all our centres, patients are queuing up to take part in an ECM study,' said Newell. While the number of trials and participants has increased hugely with the creation of the network, demand to try unlicensed drugs still far outstrips the number of slots in trials by anywhere between five and ten to one, he estimates. But Newell promises that by 2012 every terminal cancer sufferer with no other hope who wants to try the drugs will be able to, provided that they are well enough to take part.

While science is technical, precise, unemotional, most people who are diagnosed with terminal cancer experience a maelstrom of emotions, such as despair, anger, guilt, depression and regret. Newell denies that patients entering the trials are desperate, but said: 'Patients who are candidates to be volunteers in ECM studies are often in a very emotionally fragile condition and naturally are very keen to explore any new treatment that might help them, because unfortunately there are no longer any conventional approaches that are likely to work.'

The trials offer hope, but only a small amount. On some studies the chances of a patient benefiting are only one in 20, but in others they are one in five. 'In many cases there is a limited likelihood of personal benefit in the form of an anti-tumour response or a prolongation of life,' admitted Newell. But, he added, the chances of success are and have been improving.

'There are patients who have responded to the drugs we are investigating whose tumours have stopped growing or shrunk. Therefore we would predict that they would live longer than they might otherwise have done. Some patients in trials have responded to treatments for months and sometimes years. These drugs could mean patients living for years longer than expected. That's unusual, but it does happen.'

Cancer drugs have become a sensitive political issue. Local NHS organisations are regularly criticised for denying patients expensive but potentially life-prolonging drugs. In 2005 ex-nurse Barbara Clark fought such a strong campaign to be prescribed the breast cancer treatment Herceptin that then Health Secretary Patricia Hewitt took the unusual step of declaring that it should not be refused to women on grounds of cost, despite the supposedly independent National Institute for Clinical Excellence (Nice) having failed to endorse it as cost-effective. Thousands of women now get it who would otherwise not have done.

Last week the issue was in the news once again when four new drugs to treat advanced kidney cancer - Sutent, Avastin, Nexavar and Torisel - were rejected as being too expensive for use by the NHS. Although the drugs can extend life by up to six months, Nice concluded that the money would be better spent elsewhere. The decision outraged charities, kidney specialists and campaigners who said that many patients did not respond to the only other treatment option. The NHS has also been criticised widely for its policy of withdrawing its treatment from terminally ill cancer patients who 'top up' their care by buying drugs privately that Nice has not approved, although the policy is now under review.

Cancer sufferers' clamour for anything that might help them will become louder in the next few years as greater numbers of increasingly effective but very costly new cancer drugs become available just as ageing produces more diagnoses of the disease.

The possibility of being among the lucky few ECMC patients who gain extra months or years, however small, is a powerful motivation. Plenty of patients will take the risks the drugs involve in order to potentially buy themselves more time. 'You might find out there's something that will keep you going,' said Nick Carter, a patient in Yorkshire whose cancer did not respond to an experimental drug. Or as Ruth Potts, who is currently involved in a trial in Belfast, said: 'As long as there's a little bit of hope, then there's life.' Volunteers are driven by a desire to spend more time with their families, fulfil ambitions, take a holiday and get their affairs in order before they die.

Staff working on the trials do their best to keep patients' hopes realistic. They spell out clearly the low chance of success and the risks before seeking 'informed consent' in writing. 'Every drug is potentially toxic. And every drug can have side-effects, which could be damage to the blood cells, so that patients get infections or anaemia or fatigue', said Newell. 'There could be life-threatening side-effects, but that's very rare. We monitor patients closely, and if there are early signs of side-effects we can stop or reduce the treatment.'

Tests in laboratories, usually involving mice or rats, yield only so much knowledge. Sooner or later real patients are needed to help translate research into, hopefully, new drugs - a process scientists call 'from bench to bedside'. These trials in experimental drugs are vital in that. 'We need human beings to take risks,' said Newell. Experiments to ascertain the right dosage, for example, may involve suffering along the way. Ethically, only patients who have exhausted all other options are allowed to take part in these trials, although others exist for patients still being treated on the NHS.

Unlike normal cancer care, experimental cancer medicine constantly asks scientific questions while the patient is being treated. How is the drug working in the patient? Are the side-effects acceptable? Is it getting to the tumour or tumours in the right levels to be able to kill the tumour cells? And is there early evidence the drug may go on to be a useful cancer therapy? Increasingly the answer to that last question is yes.

'These are fantastically exciting times in cancer research,' said Newell. 'We now understand what goes wrong in cancer at a level that we didn't 20 or 30 years ago. That knowledge is allowing us to discover and design new cancer treatments that for the first time target the underlying lesions that cause cancer.'

Herceptin, which helps stop breast cancer returning in one in four women whose disease will respond to the treatment, was only developed in the past decade. So, too, was Avastin, which can prolong the lives of bowel cancer sufferers. Survival has improved for almost every major common cancer in both sexes, particularly over the past 10 years. For instance, the number of women newly diagnosed with breast cancer who survive for five years is now more than 80 per cent; in the Seventies, it was only 50 per cent.

While a tumour is the physical manifestation of cancer, a lesion is what has gone wrong in a normal, healthy cell to turn it into a cancer cell. Because cancer is caused by accumulated genetic defects, scientists in these trials are paying particular attention to the proteins produced by those genes, so they can develop drugs to attack them.

At the ECM centre at Southampton University, Professor Christian Ottensmeier and his colleagues are trying to develop vaccines for particular cancers, such as prostate cancer - a huge breakthrough, if it happens. 'The idea is that we would try to make the immune system aware that there's a cancer that it has to fight. If it did that already, we wouldn't have cancer,' says Ottensmeier.

He is particularly hopeful about an immune-activating molecule called anti-CD40, or Chilob, which appears to have significantly helped Brian Cramp and another patient on the trial. 'It appears to act like a flag on the cancer cells to tell the immune system to kill them. It's very promising. If it worked it might offer the opportunity to treat cancers that we currently don't have very good medicines for, such as melanoma [skin cancer] and mesothelioma [lung cancer],' said Ottensmeier.

In Leeds, Professor Chris Twelves and his team are exploring the new generation of targeted cancer drugs. Conventional chemotherapy treatments are cytotoxics - they poison the cancer but can also poison the patient at the same time. By contrast the newer drugs have been designed to attack the pathways, or wiring, of the cancer cells. 'It's a bit like the difference between trying to break into a house by throwing a bomb in the front door, which will get you in but will have done some damage, and picking the lock on the side door.'

While much remains unknown about cancer, the ECM network is working to replace confusion with certainty and ignorance with hard, reliable information about how well a drug works.

'It's constantly humbling to us as cancer scientists to know that, even when patients have reached that point in their personal cancer journey, they are still prepared altruistically to offer themselves to take part in clinical trials. We are fantastically grateful,' said Newell.

'The reality is that there is never going to be one "magic bullet" that cures all cancers. We're now looking at building an arsenal of weapons to target individual cancers,' he added.

ECM drugs are not cures and do not represent miracles; at best they might prolong life, nothing more. As Nick Carter said: 'The drug you get won't necessarily cure you, or even delay the progress of your cancer. And it might even kill you. Joining a trial is a huge gamble.'

The big prize in cancer research is turning a disease that has usually represented an automatic death sentence into a chronic condition that can be managed, in the way that many people live for years with diabetes, heart disease or obesity. Progress towards that goal is real and substantial, and ECM trials are playing a key part. In years to come, as our ageing population means cancer wreaks an ever-growing toll, many of us may well have reason to remember and be grateful for these pioneer patients.

· There is more information about UK cancer trials, including ECM trials, on the clinical trials database on Cancer Research UK's patient information website, cancerhelp.org.uk. Anyone with questions about cancer or clinical trials can call Cancer Research UK's specialist information nurse team on freephone 0808 800 4040. Lines are open from 9am-5pm, Monday to Friday.

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(Guardian.co.uk., The Observer, By Dennis Campbell, The Observer, Article History, August 10, 2008)


The information contained in these articles may or may not be in agreement with my own opinions. They are not posted as medical advice of any kind.

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  • 2 weeks later...
"...by 2012 every terminal cancer sufferer with no other hope who wants to try the drugs will be able to, provided that they are well enough to take part..."


I can't help but compare this to the U.S. where the FDA went all the way to the Supreme Court in order to ensure that dying cancer patients (Stage IVB) couldn't take experimental drugs because the drug might kill them. :(



I'd rather die while I'm living then live while I'm dead.--Jimmy Buffett

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Probably, it will take a very long time to change present thinking entrenched in the system, but it does make me wonder where priorities are in "doing no harm."

Shouldn't there be some new thinking employed in making decisions on what not-yet-approved treatments could be used, and give a person a fighting chance?

Am not thinking to be cavalier about this.


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