The UK is the only country in Europe where patients with metastatic colorectal cancer do not have routine access to Merck KGaA’s Erbitux, a drug with potential to extend survival and even cure some people, it has been revealed.

Erbitux (cetuximab), approved in countries all over the world thanks to a British-led study, is able to arrest growth and spread of aggressive tumours and causes cancer cell death. Oncologists say it has produced some of the longest survival rates ever seen in metastatic colorectal cancer.

But a draft appraisal issued June 2006 by NICE, the UK’s National Institute For Clinical Excellence, indicated Erbitux and another targeted drug – Roche’s Avastin (bevacuzimab) - is likely to be turned down for use in Britain on cost-effectiveness grounds. A final decision will be made in November.

Dr Oliver Kisker, medical director of Merck, said recently: “The UK is the only country in Europe where the drug has been approved but is not available. In all other European countries, specialists can use the drug and get the cost reimbursed.”

Speaking in Barcelona during the 8th World Congress in Gastrointestinal Cancer in June, Professor Heinz-Josef Lenz said the trial that led to Erbitux being approved all over the world was led by Professor David Cunningham in Britain.

“Originally the trial had the number 007 but to the British that means James Bond so the trial is known as BOND.” The trial showed Erbitux could overturn a cancer’s power to resist chemotherapy and increase survival. “No other drugs have shown that,” he commented. Since BOND, Erbitux has gone on to produce outstanding results in small trials and is now being tested in much larger numbers of patients, he said.

Shrinking liver tumours become respectable

A major benefit to emerge is the ability of the drug to shrink liver metastases in around a quarter of patients with advanced disease to the point where they can be resected. Resecting liver secondaries gives patients the best chance of survival, he added. “New combinations of Erbitux and the chemotherapy regimen FOLFOX 4 are expected to translate to a cure for an increasing number of patients.“

Also speaking in Barcelona, Tim Maughan, professor of cancer studies at Cardiff University said: “Where tumours in the liver are resectable, long-term follow up shows that half are still alive after five years and almost a third are still alive a decade later.” If tumours in the liver become resectable after Erbitux and chemotherapy, more patients will become survivors, he explained.

Three studies show that about 23%-24% of previously inoperable patients become candidates for surgery. “These are recent data and open up the hope of a radically different long-term outcome than we have come to expect. The ball park in metastatic colorectal cancer treatment is shifting raipidly. We can get long-term survival benefits without compromising quality of life.”

Professor Maughan is one of few cancer specialists likely to see any benefits of Erbitux in Britain because he practices in Wales. Until the NICE decision is finalised, Wales is permitting its gastro-intestinal cancer specialists to prescribe the drug strictly within its licensed indication for patients who have failed chemotherapy with irinotecan.

Professor Maughan happens also to be leading from Wales, the UK Medical Research Council’s independently-financed massive study of Erbitux and chemotherapy. The COIN study is comparing continuous and intermittent chemotherapy with and without Erbitux in over 2000 patients.

However, any discoveries made by the COIN study are unlikely to be enjoyed by the UK, the country that paid for the study via its sponsorship of the MRC.

As Neil Brookes, CEO of the UK colon cancer charity “Bowel Cancer UK” commented: “It is ironic that while the UK has been in the forefront of developing both Erbitux and Avastin, including in clinical trials, it looks as if we will, once again, be at the very back of the queue when it comes to being able to make them available to patients. It is also very hard not to be angry and cynical when NICE appears to be making its decisions on the basis of financial expediency rather than clinical efficacy.”

Olwen Glynn Owen