A trial looking at treatment for advanced bowel cancer (COIN trial)

Cancer type:

Bowel (colorectal) cancer

Colon cancer

Rectal cancer

Status:

Results

Phase:

Phase 3

This trial was looking at cetuximab (Erbitux) and chemotherapy for bowel cancer that had spread. This trial was supported by Cancer Research UK.

Doctors often use chemotherapy to treat advanced bowel cancer. In this trial they were looking at two new treatment options.

The first treatment they looked at was giving cetuximab (Erbitux) as well as chemotherapy. Cetuximab is a monoclonal antibody. It had been tested in clinical trials for patients who had already had a lot of treatment for bowel cancer. But this trial tested it in patients who had not yet had treatment for bowel cancer that had spread. (They may have had treatment in the past for the primary cancer in the bowel.) Doctors hoped that cetuximab would make the chemotherapy work better.

The second treatment they looked at was stopping chemotherapy after 12 weeks. Patients then had regular tests to check for signs that the cancer had started to grow again. If it had, they had another 12 weeks of chemotherapy. And so on. Doctors hoped that intermittent chemotherapy would be as good as continuous chemotherapy, and that it would cause fewer side effects.

The aims of this trial were to find out

How well chemotherapy and cetuximab worked for advanced bowel cancer
If giving chemotherapy for 12 weeks at a time was as good as continuous chemotherapy, and if it caused fewer side effects
Which treatment was best for advanced bowel cancer
What effect each treatment had on quality of life

Summary of results

The results showed that

Having cetuximab did not affect how long people lived after treatment
People who had continuous chemotherapy lived a few weeks longer than those who had intermittent treatment

The trial recruited 2,445 people who had advanced bowel cancer. Their average age was 63.

The researchers found that on average, having continuous chemotherapy increased the length of time people lived by 6 weeks. But it meant having an average of 10 weeks more treatment.

People who had continuous treatment had more problems with the chemotherapy affecting the nerves in their hands or feet (peripheral neuropathy). And with their hands and feet becoming red and sore (Plantar Palmar syndrome).

We know from recent research that having a genetic change called a K-RAS mutation means cetuximab is not likely to help you. People with bowel cancer are now tested for this before starting treatment. But this trial started before this was known. The researchers were able to look back afterwards and see who had this genetic mutation Open a glossary item .

The trial team found that in people who didn’t have the genetic mutation, cancer responded to treatment more often if their treatment included cetuximab. But this made little or no difference to the length of time people lived after having treatment. And people having cetuximab had more side effects, including skin rash and diarrhoea.

The researchers looked at how long it took for cancer to start growing again and how long people lived (on average) after the start of treatment. When looking at everybody who took part in the trial, they found both of these were about the same whether or not people had cetuximab. And even when only looking at people who didn’t have the K-RAS genetic mutation, there was still no difference.

We have based this summary on information from the team who ran the trial. The information they sent us has been reviewed by independent specialists (peer reviewed Open a glossary item ) and published in a medical journal. The figures we quote above were provided by the trial team. We have not analysed the data ourselves.