A trial looking at treatments for different types of bowel cancer (FOCUS4)

Trial design
This trial was for people who:

• had bowel cancer that had grown outside the bowel or had spread to another part of the body (advanced cancer)
• had not had treatment for advanced cancer before
• were not able to have an operation to remove their cancer 

They were all due to have chemotherapy.

A total of 361 people had treatment in 1 of 4 groups. The group they were in depended on the results of genetic analysis. There were:

• 6 people in FOCUS4-B (there are no results for this part of the trial)
• 69 people in FOCUS4-C
• 32 people in FOCUS4-D
• 254 people in FOCUS4-N

Within each of these main groups, people were put into 1 of 2 treatment groups at random. There is more detail about each group below.

Results

FOCUS4-C
There were 69 people in this part of the trial:

• 44 people had adavosertib
• 25 people had regular tests and check ups (active monitoring)

The team looked at how long it was before people’s cancer started to grow again. They found it was:

• 3.6 months for those who had adavosertib
• 1.9 months for those who had active monitoring

When they looked at how long people lived, they found it was similar in the two groups.

Everyone taking part had at least one side effect of treatment. Most were mild or didn’t last long, but some were more severe. The most common of the more severe side effects were diarrhoea, feeling sick and a drop in white blood cells.

They concluded that adavosertib could be a useful treatment for this group of patients. They suggest larger trials are done to find out more.

FOCUS4-D
There were 32 people in this part of the trial:

• 16 had sapitinib
• 16 had a dummy drug (placebo)

The research team looked at the results part way through. This is called an interim analysis. They found that there was little difference between the two groups. So they decided to close FOCUS4-D.

When they looked at how long it was before the cancer started to grow, they found it was:

• 3 months for those who had sapitinib
• 3.5 months for those who had a dummy drug (placebo)

As with FOCUS4-C, most of the side effects were mild. The most common of the more severe side effects of sapitinib was a rash.

The team concluded that this trial didn’t show that sapitinib was a useful treatment for this group of patients. 

FOCUS4-N
There were 254 people in this part of the trial:

• 127 had capecitabine
• 127 had regular tests and check ups (active monitoring)

The team looked at how long it was before people’s cancer started to grow. They found it was:

• 3.9 months for those who had capecitabine
• 1.9 months for those who had active monitoring

When they looked at how long people lived, they found there was no difference between the groups.

The side effects of capecitabine were as expected. The most common ones were extreme tiredness, diarrhoea and redness on hands and feet. 

The team concluded these results suggest having a break from chemotherapy doesn’t affect how long people live. They also suggest that capecitabine could be used to give people a longer break before re-starting other chemotherapy.

More detailed information
There is more information about this research in the references listed on the website below. 

Please note, the articles included in the link below are not in plain English. They have been written for health care professionals and researchers.

http://www.focus4trial.org/focus4-news/

Where this information comes from    
We have based this summary on the information in the articles above. These have been reviewed by independent specialists (peer reviewed)  and published in medical journals. We have not analysed the data ourselves.