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.
- People in one group had chemotherapy alone.
- People in the other group had chemotherapy combined with radioembolisation.
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.
Combined results of 3 trials
The results of this trial were looked at and combined with the results of 2 other trials. These were the:
- SIRFLOX trial
- FOXFIRE-Global trial
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:
- 549 people had chemotherapy alone
- 554 people had chemotherapy plus radioembolisation
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:
- about 23 months in the chemotherapy group
- about 23 months in the chemotherapy plus radioembolisation group
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:
- 411 people (75%) had died in the chemotherapy group
- 433 people (78%) had died in the chemotherapy plus radioembolisation group
The trial team concluded the difference between these groups was not significant.
Control of liver secondaries
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:
- reduced in size
- could no longer be found on scans
These are called an objective response. Out of the 1103 people, an objective response was found in:
- 346 people (63%) in the chemotherapy group
- 400 people (72%) in the chemotherapy plus radioembolisation group
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.
Side effects and quality of life
Those people who had radioembolisation had more side effects following this treatment. These included:
- a drop in the number of white blood cells called neutrophils, leading to infection
- tummy (abdominal) pain
- feeling sick or being sick
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.