A trial looking at oxaliplatin and 5FU for advanced biliary tract cancers (ABC-06)

The research team found that FOLFOX may be a useful treatment for people with biliary tract cancer that has got worse after previous chemotherapy.

Trial design
This trial was for people who had already had chemotherapy. But their cancer continued to grow, either straight after treatment or a little while later.  

The people taking part were put into a treatment group at random. Some people had active symptom control as usual. And some had FOLFOX chemotherapy as well as active symptom control.

Results
A total of 162 people joined this trial. There were:

• 117 people with bile duct cancer
• 34 people with gall bladder cancer 
• 11 people with ampullary cancer

They were put into a treatment group at random:

• 81 had active symptom control (ASC)
• 81 had active symptom control and FOLFOX chemotherapy

Diagram 1

The research team looked at how many people were living after 6 months, they found it was:

• more than 3 out of 10 people (36%) who had ASC
• just over 5 out of 10 people (51%) who had ASC and FOLFOX

Bar Chart 1

And the number of people living at 12 months was:

• just over 1 out of 10 people (11%) who had ASC
• more than 2 out of 10 people (26%) who had ASC and FOLFOX

Bar Chart 2

Side effects
Many people who took part had at least 1 side effect from treatment. Some were mild or didn’t last long. But some people in each group had more severe side effects:

• 42 people (52%) who had ASC 
• 56 people (69%) who had ASC and FOLFOX

The most common of the more severe side effects were:

• a drop in white blood cells
• extreme tiredness (fatigue)
• infection

Three people who had FOLFOX died because of side effects of treatment:

• one person had sudden and serious kidney damage (acute kidney injury)
• one person had an infection
• one person had a drop in white blood cells and a temperature (febrile neutropenia)

We have more information about the side effects of FOLFOX chemotherapy in our cancer drugs section.

Conclusion
The trial team concluded that FOLFOX is a useful treatment for people with advanced biliary tract cancer. 

They suggest this combination should be standard treatment for people whose cancer has come back after chemotherapy. They now have information on the pros and cons of FOLFOX, so patients can discuss whether they would like this treatment or not.

Where this information comes from    
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.