The trial doctors concluded that imgatuzumab does not help people with advanced bowel cancer.
169 people took part in this phase 2 trial
. Everyone was having treatment for the 2nd time for advanced bowel cancer.
Doctors asked everyone to give a tissue sample (a biopsy
) to look for changes (mutations) in the KRAS gene
. Based on this result, everyone was put into treatment groups.
Group A was for people who didn’t have any changes in the KRAS gene. Group B was for people who had changes in the KRAS gene.
People in treatment group A were then put into 1 of 2 groups at random
- imgatuzumab and FOLFIRI (group 1)
- cetuximab and FOLFIRI (group 2)
And people in treatment group B were put into 1 of 2 groups at random:
- imgatuzumab and FOLFIRI (group 3)
- FOLFIRI alone (group 4)
Neither they nor their doctor could choose which group they were in.
Doctors looked at how well imgatuzumab worked. To do this, they looked at how long people lived before their cancer started to grow again. This is called progression free survival. Doctors found that it was around:
- seven months for group 1
- six months for group 2
- five months for group 3
- four months for group 4
Doctors looked at the moderate and severe side effects people had. These included:
- skin rash
- low levels of magnesium in the blood
- an increased risk of infection (neutropenia)
People who had imgatuzumab (group 1 and group 3) had more problems with skin rashes and had lower levels of magnesium. And people who had cetuximab (group 2) had worse neutropenia.
The trial doctors concluded that adding imgatuzumab to FOLFIRI does not help people with advanced bowel cancer, with or without changes in the KRAS gene.
We have based this summary on information from the research team. The information they sent us has been reviewed by independent specialists (peer reviewed
) but may not have been published in a medical journal. The figures we quote above were provided by the research team. We have not analysed the data ourselves.