A trial looking at different types of chemotherapy for acute myeloid leukaemia (AML12)

Cancer type:

Acute leukaemia

Acute myeloid leukaemia (AML)

Blood cancers

Leukaemia

Status:

Results

Phase:

Phase 3

This trial compared how well different treatments worked to

Get AML into remission
Stop the leukaemia from coming back

All the treatments had been used before and were known to work, but doctors were not sure which was best.

Some people taking part in the trial also had a drug called retinoic acid (also known as ATRA) to see if it helped one type of chemotherapy to work better.

More about this trial

Doctors usually treat acute myeloid leukaemia with chemotherapy. The treatment is divided into 2 stages. The first stage is induction chemotherapy. This aims to get rid of any active disease (remission Open a glossary item ). Then you have consolidation treatment to try to stop the leukaemia from coming back.

The aims of this trial were to find out

How well different types of induction chemotherapy worked
If retinoic acid helped one type of chemotherapy to work better
Whether people who had 5 courses of treatment in total lived longer than people who had 4 courses
If people having a stem cell transplant as part of their consolidation treatment lived longer

Summary of results

The trial team found that

The different types of induction chemotherapy worked about as well as each other and people lived for the same length of time whichever treatment they had
Adding a 5th course of consolidation treatment did not change the length of time people lived after treatment (overall survival)
Having a stem cell transplant reduced the risk of leukaemia coming back, but did not make a difference to overall survival

This trial recruited 3,459 people who were put into treatment groups by a computer. This is called randomisation. At the start of the trial, people were randomised to have one of the following combinations of chemotherapy drugs as induction treatment

Ara C, daunorubicin and etoposide (ADE)
Mitoxantrone, Ara C and etoposide (MAE)

Some people were also randomised to have a growth factor called G-CSF or to have a dummy drug (placebo). The results showed that 81 out of every 100 people (81%) responded to G-CSF. Their overall survival was a little worse. But there was not much difference to how well they recovered after treatment or the time it took for leukaemia to come back.

People joining the trial from November 1998 onwards had a combination of daunorubicin, Ara c and thiogaunine (DAT). They were randomised to have either a standard dose of Ara C or double the standard dose. They were also randomised to have ATRA or not.

After the induction chemotherapy, 85 out of every 100 people (85%) had no sign of their leukaemia on examination or tests. The results showed that ATRA made no difference to the treatment outcome.

At consolidation treatment, people could be randomised to have a total of either 4 or 5 courses of treatment. They could also be randomised to have either chemotherapy or a stem cell transplant as their last course of treatment.

The researchers followed up the people taking part for an average of about 8 and a half years. They found that neither a 5th course of treatment nor a stem cell transplant made a difference to overall survival.

We have based this summary on information from the team who ran the trial. 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. We have not analysed the data ourselves.