A trial of chemotherapy and radioembolisation for bowel cancer that has spread to the liver (FOXFIRE)

The trial team found that having the combination of radioembolisation and chemotherapy did not improve how long people lived for after treatment for people with liver secondaries.

 

This was a phase 3 trial and it was randomised. The people taking part were put into 1 of 2 treatment groups by a computer. Neither they nor your doctor could decide which group they were in.

Everybody taking part had the chemotherapy drugs oxaliplatin and 5FU (fluorouracil), along with a vitamin called folinic acid. People had a chemotherapy regime called OxMdG or FOLFOX. The dose and timing of the drugs is slightly different with each regime but they contain the same drugs. Each cycle of treatment was over 2 weeks. On average, most people in the trial had 12 cycles of treatment.

 

People in group B had radioembolisation once during their 2nd cycle of chemotherapy.

 

The results of this trial were looked at and combined with the results of 2 other trials. These were the:

These trials recruited people from other countries in Europe as well as Australia, New Zealand, Asia, the Middle East and USA. Both these trials recruited a similar group of people with liver metastases. People had slightly different chemotherapy regimes, but with the same chemotherapy drugs. Around half of the people in these trials had radioembolization in combination with chemotherapy.

 

Across the 3 trials:

At the time the results were published, all 3 trials had completed at least 2 years of follow up of their patients.

 

The researchers looked at how long people lived for after treatment (overall survival). They found that on average, this was:

So the team concluded that adding radioembolisation to chemotherapy did not improve the overall survival for these people compared to chemotherapy alone.

 

The trial team also recorded who had died from any cause. This was:

The trial team concluded the difference between these groups was not significant.

 

The trial team specifically looked at the liver secondaries of those taking part. They did this by looking at people’s scans They recorded whether the liver secondaries:

These are called an objective response. Out of the 1103 people, an objective response was found in:

Significantly more people in the radioembolisation group had a response on scans. But this did not lead to an improved survival in this group of people. The researchers think this is because people in this group had less chemotherapy after the trial, compared to the group who only had chemotherapy.

 

Those people who had radioembolisation had more side effects following this treatment. These included:

Those people who had radioembolisation had less numbness in their fingers and toes.

 

Everybody taking part filled out a questionnaire about quality of life at different points during and after their treatment. The trial team concluded that people in both treatment groups had a similar quality of life.

 

The researchers do not recommend radioembolisation as an initial treatment in combination with chemotherapy for bowel cancer that has spread to the liver.

 

They believe that further trials should look at radioembolisation in selected groups of people with bowel cancer and liver secondaries. For example, as a possible treatment after chemotherapy has stopped working. Or as a treatment in patients who do not do as well with standard chemotherapy treatments.

 

We have based this summary on information from the research team. 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 who did the research. We have not analysed the data ourselves.