A trial comparing bosutinib with imatinib as treatment for chronic myeloid leukaemia

Cancer type:

Blood cancers
Chronic leukaemia
Chronic myeloid leukaemia (CML)
Leukaemia

Status:

Results

Phase:

Phase 3

This trial compared bosutinib with imatinib to treat newly diagnosed chronic myeloid leukaemia (CML). 

More about this trial

There are different phases of chronic myeloid leukaemia (CML). They are:
  • chronic phase
  • accelerated phase
  • blast phase
This trial was for people with CML in the chronic phase. This is when the leukaemia is still developing slowly.
 
Doctors can treat chronic phase CML with a drug called imatinib (Glivec). This works well, but researchers wanted to see if bosutinib (Bosulif) would work better and not cause too many side effects.
 
Bosutinib is a type of cancer growth blocker. It stops signals that cancer cells use to grow and divide.
 
The aims of this trial were to find out:
  • if bosutinib works better than imatinib
  • how well bosutinib works for chronic phase CML
  • more about the side effects

Summary of results

This trial showed that bosutinib worked better than imatinib and didn’t cause too many side effects.
 
The research team recruited patients in 2014 and 2015, and published the results in 2017.
 
Results
This trial recruited 536 people with newly diagnosed chronic myeloid leukaemia (CML). They all had CML that was in the chronic phase. They were put in to 1 of 2 treatments groups at random, and:
  • half had bosutinib tablets once a day
  • half had imatinib tablets once a day
The trial team looked at how well the drugs worked a year after starting treatment. They measured this in two ways. 
 
The first way they measured how well treatment worked was to look for the number of leukaemia cells in blood samples. It’s called major molecular response (MMR) when there are only a very tiny number of these cells in the blood. 
 
The number of people who had a major molecular response was:
  • nearly 5 out of 10 people (47%) who had bosutinib
  • nearly 4 out of 10 people (37%) who had imatinib
The second way they measured how well treatment worked was to look for cells in the bone marrow that have a specific genetic change. It’s called complete cytogenetic response (CCyR) when there are none of these cells in the bone marrow. 
 
The number of people who had a complete cytogenetic response was:
  • nearly 8 out of 10 people (77%) who had bosutinib
  • nearly 7 out of 10 people (66%) who had imatinib 
They also found that people who had bosutinib responded to treatment quicker than those who had imatinib.
 
When they looked at how many people’s leukaemia had progressed to either the accelerated phase or the blast phase, it was:
  • 4 people (1.6%) who’d had bosutinib
  • 6 people (2.5%) who’d had imatinib
Side effects
Nearly everyone taking part had at least 1 side effect. But some were mild or went away with time. The number of people who had more severe side effects was:
  • nearly 6 out of 10 people (56%) who had bosutinib
  • more than 4 out of 10 people (43%) who had imatinib
The most common side effects of bosutinib were:
  • diarrhoea
  • feeling sick
  • a drop in blood clotting cells (platelets)
  • a change in liver function tests
The most common side effects of imatinib were:
  • feeling sick
  • diarrhoea
  • muscle spasms
  • a drop in a specific type of white blood cell (neutrophils)
Conclusion
The research team concluded that bosutinib worked better than imatinib for people with newly diagnosed chronic phase chronic myeloid leukaemia. And that it didn’t cause too many serious side effects. They suggest it could be a useful treatment option for people in this situation.
 
We have based this summary on information from the research team. The information they sent us has been reviewed by independent specialists (peer reviewed Open a glossary item) 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.
 

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Dr Jenny Byrne

Supported by

NIHR Clinical Research Network: Cancer
Avillion
Pfizer

Cancer Research UK trial number

12507

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

12507

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Around 1 in 5 people take part in clinical trials

3 phases of trials

Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.

Last reviewed:

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