A trial looking at imatinib for advanced gastrointestinal stromal tumours

Cancer type:

Sarcoma

Soft tissue sarcoma

Status:

Results

Phase:

Phase 1

This trial was looking at imatinib for advanced gastrointestinal stromal tumours including those that have spread to another part of the body (metastatic Open a glossary item tumours).

Doctors usually treat gastrointestinal stromal tumours (also known as GIST) with surgery. But sometimes the cancer comes back after treatment. And if a GIST is advanced, or has spread to another part of the abdomen, or to the liver, it may not be possible to remove it all with surgery.

In this trial, the researchers looked at imatinib (previously called STI571 and also called Glivec). Imatinib had already been used to treat leukaemia.

The aim of the trial was to see if imatinib helped people with advanced GIST.

Summary of results

The researchers found that imatinib helped people with advanced GIST. The trial recruited 946 people in 13 different countries. Half the people taking part had imatinib once a day the other half had it twice a day. They carried on taking it for as long as it helped them.

In 52 people (5%) all signs of the cancer went away – doctors call this a complete response
In 442 people (47%) the cancer got smaller – doctors call this a partial response
In 300 people (32%) the cancer remained the same – doctors call this stable disease
In 152 people (16%) the cancer continued to grow

There was no difference in these response rates between people taking imatinib once a day and people taking it twice a day.

Side effects included

A build up of fluid in the body (oedema)
Skin rash
Tiredness (fatigue)
Diarrhoea and sickness
A drop in the number of blood cells

The trial team published their results in 2004. After following up the people taking part for an average of just over 2 years, they found that the GIST had started to grow again in

56% of the people who had imatinib once a day
50% of the people who had it twice a day

So the number of people who lived for more than 2 years, without their tumour starting to grow again, was higher in the group who had the drug twice a day. If the cancer began to grow again in someone who had been taking imatinib once a day, the doctors offered them the option of starting to take it twice a day.

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.