A trial comparing azacitidine with usual treatment for older people with newly diagnosed acute myeloid leukaemia

Cancer type:

Acute leukaemia

Acute myeloid leukaemia (AML)

Blood cancers

Leukaemia

Status:

Results

Phase:

Phase 3

This trial compared a chemotherapy drug called azacitidine with the usual treatment for older people with acute myeloid leukaemia (AML).

More about this trial

Doctors usually treat AML with chemotherapy. To get rid of the AML they can use chemotherapy drugs such as cytarabine and daunorubicin.

This does not always work for older people (over the age of 65) with AML. So doctors are looking for ways to improve treatment for this group of people.

The researchers thought that another low intensity chemotherapy drug called azacitidine could work better.

The aims of this trial were to

Find out if azacitidine or usual treatment worked better for newly diagnosed AML in older people
Learn more about the side effects

Summary of results

The trial team found that azacitidine could be a useful treatment for older people with AML and the side effects were similar to the usual treatments.

488 people age 65 and over took part. Of those,

241 had azacitidine and best supportive care
247 had 1 of the following 3 usual treatments

                 o Cytarabine and daunorubicin or idarubicin and best supportive care
                 o Low dose cytarabine and best supportive care
                o Best supportive care

Best supportive care means treatment to help with symptoms or side effects of any leukaemia treatment. This could include

Blood transfusions
Antibiotics to fight infection
Food supplements

The trial team looked at how long people lived for after treatment. They found this was on average

Just over 10 months for people who had azacitidine
6 ½ months for people who had usual treatments

The most common side effects of azacitidine were

Feeling sick
A drop in the number of platelets and white blood cells

People in the usual treatment groups had similar side effects, apart from the people who had best supportive care alone. They had the fewest side effects.

The trial team suggest that azacitidine is a useful and safe treatment for older patients with newly diagnosed AML.

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