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COIN trial in advanced bowel cancer - Results presented at ECCO/ESMO conference and NCRI meeting

13 October 2009

SUMMARY

The first results from the MRC COIN trial, the largest trial in advanced bowel cancer carried out to date, were presented at the National Cancer Research Institute annual conference in Birmingham on 6 October. The results provide more information about the potential effect different treatment options can have and so will help patients and clinicians to make treatment decisions. The research was funded by the Medical Research Council, Cancer Research UK, the National Cancer Research Network and Merck Serono.

PRESS RELEASE

More than 16,000 people die from bowel cancer in the UK every year. The COIN trial focused on two distinct questions of importance to patients with advanced bowel cancer. Firstly, whether adding an additional newer drug, called cetuximab, to standard chemotherapy could benefit patients by increasing lifespan and secondly, whether taking breaks from standard chemotherapy could minimize side-effects, reduce time on treatment and improve patients’ quality of life whilst also having minimal impact on lifespan.

Previous trials have shown that cetuximab is effective only in those patients whose tumours have a normal form of a gene called KRAS. The COIN trial investigators found that adding cetuximab to the standard chemotherapy did not improve survival in these patients. However, on closer inspection of the results, there was a suggestion that patients who received the standard drugs capecitabine/oxaliplatin with cetuximab showed no benefit, whereas those who received the alternative standard drug combination fluourouracil/oxaliplatin with cetuximab did show a trend to benefit. This was supported by comparison with other trials of cetuximab in similar patients with advanced bowel cancer. MRC investigators are planning further analyses of the COIN data to try to explore the reasons for these differences.

Lead investigator Professor Tim Maughan of Cardiff University explains: "The trial results show that overall, advanced bowel cancer patients who received cetuximab in addition to standard chemotherapy did not benefit, though this may be due to the combination of chemotherapy drugs. The team plans further analyses of the data to try to explore the reasons for the results we have obtained."

The second comparison in the COIN trial was between the standard continuous chemotherapy (control arm) versus the same chemotherapy given with planned treatment breaks (intermittent therapy). Patients who received the intermittent approach spent less time on chemotherapy than patients in the control arm, overall 10 weeks less. They also experienced fewer side-effects. Balanced against this, patient survival was 1.4 months shorter with intermittent chemotherapy. This median figure of 1.4 months is the length of time that half of patients fell above or below. MRC investigators are now planning further analyses of this comparison, and in particular plan to analyse patient’s quality of life experience on these two approaches to treatment.

Professor Tim Maughan concluded: "Although these results don’t give a clear indication that one treatment option is better than another, they do provide more information about the potential effect different treatment options can have. The results will help inform patient-clinician discussions and ultimately decisions on individual treatment."

The COIN trial supports the MRC's aim to enable better therapeutic interventions and a reduction in side effects of treatments based on better knowledge of how genetics can influence a person’s response to a therapy. This stratified approach to the genetic basis of research is an integral part of the MRC’s Strategic Plan for future medical research, Research Changes Lives.

For almost 100 years the Medical Research Council has improved the health of people in the UK and around the world by supporting the highest quality science. The MRC invests in world-class scientists. It has produced 28 Nobel Prize winners and sustains a flourishing environment for internationally recognised research. The MRC focuses on making an impact and provides the financial muscle and scientific expertise behind medical breakthroughs, including the first antibiotic penicillin, the structure of DNA and the lethal link between smoking and cancer. Today MRC funded scientists tackle research into the major health challenges of the 21st century.