A trial looking at adding cetuximab to chemotherapy for bowel cancer that has spread to the liver (New EPOC)

This trial was for people with bowel cancer that had spread to the liver and were suitable to have surgery.

The researchers found that adding cetuximab to chemotherapy didn’t help people to live longer. They also found that the length of time people lived for was less in those who had cetuximab and chemotherapy. This was when they compared them with those who had chemotherapy on its own. Why this happened is not clear. So the researchers are looking into this to find out more. 

About this trial
This was a phase 3 trial. 272 people took part. They all had bowel cancer that had spread to their liver and were well enough to have:

• chemotherapy 
• surgery to remove the cancer in the liver 

Some bowel cancers that spread have a change to a gene called K-RAS. We know from research that cetuximab doesn't help people whose bowel cancer has this gene change. So, everyone who took part had cancer with a normal K-RAS gene.

This was a randomised trial. The people taking part were put into 1 of 2 groups by computer. Neither they nor their doctors could decide which group they were in.

• 128 people had 12 weeks of chemotherapy before surgery and 12 weeks of chemotherapy afterwards.
• 129 people had 12 weeks of chemotherapy and cetuximab before surgery and 12 weeks of chemotherapy and cetuximab afterwards.

Results
In 2012, the trial team analysed some early results. To do this they looked at how long people lived without any sign of their cancer getting worse. This is called progression free survival. They found this was:

• just over 15 months (15.5) in the group having chemotherapy and cetuximab
• just under 2 years (22.2 months) in the group having chemotherapy alone

In view of these results, the committee monitoring the safety of the trial (data monitoring committee) recommended that the trial was stopped.

Even though the trial closed early, the trial team continued to follow up people who took part. They wanted to find out about treatment in the longer term. They followed everyone up for about 5 years. They looked at how long people lived after treatment. They found that on average this was: 

• 81 months in the people who had chemotherapy
• just over 55 months (55.4) in the people who had chemotherapy and cetuximab

Conclusion
The trial team concluded that adding cetuximab to chemotherapy didn’t improve treatment for people having surgery to remove bowel cancer spread to the liver.

The trial team found that people who had chemotherapy on its own lived longer than those who had chemotherapy and cetuximab. On average, people who had chemotherapy alone lived 26 months longer.

The researchers say people having surgery to remove bowel cancer spread to the liver shouldn’t have this combination of treatment.

All trial results help doctors and researchers understand more about different cancers and the best way to treat them. The researchers are looking at the biology of the tumours to learn more about how different proteins might affect which treatment people should have. This is increasing our understanding of bowel cancer that has spread.

Where this information comes from
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 ) and published in a medical journal.  The figures we quote above were provided by the trial team. We have not analysed the data ourselves.