A trial looking at chemotherapy for melanoma of the eye that has spread to the liver (EORTC 18021)

Cancer type:

Cancer spread to the liver

Eye cancer

Melanoma

Melanoma of the eye

Secondary cancers

Status:

Results

Phase:

Phase 3

This trial looked at chemotherapy for a type of melanoma of the eye (uveal melanoma) that had spread to the liver and couldn’t be removed with an operation.

More about this trial

If you have melanoma of the eye that has spread to the liver, doctors can sometimes remove the areas of cancer in the liver with an operation. But if this is not possible, it can be more difficult to treat.

This trial looked at a chemotherapy drug called fotemustine to control the cancer growth in the liver. You can have fotemustine in 2 different ways - as a drip into a vein or as treatment into an artery going to the liver. The doctors in this trial wanted to see which of these worked best for melanoma that had spread to the liver.

The aims of this trial were to find out

How well the treatment worked
Which way of giving fotemustine treatment is better at slowing down cancer growth or shrinking the tumour
More about the side effects

Summary of results

The trial team found that fotemustine into an artery near the liver worked a bit better than having it as a drip into a vein. But neither treatment was very useful for melanoma of the eye that had spread to the liver.

The trial team planned to recruit 262 people. But when they looked at the results of the trial they had so far, and how long people lived for after treatment, they found that neither way of giving fotemustine was working as well as they had hoped. So they decided it was best not to recruit any more people.

So 171 people took part and

Half had fotemustine into an artery near the liver
Half had fotemustine as a drip into a vein

The results were published in 2014. The researchers found the cancer got smaller or stopped growing in

9 of the 86 people (about 10%) who had fotemustine into an artery
2 of the 85 people (about 2%) who had fotemustine into a vein

They looked at the difference in the time it took for the cancer to start growing again. On average it was about

4½ months for people who had fotemustine into an artery near the liver
3½ months for people who had fotemustine into a vein

The researchers also looked at how long people lived for after treatment. They found there was no difference between the 2 groups.

The main side effects were a drop in a type of blood cell called platelets causing bleeding, and a drop in white blood cells causing an increased risk of infection. This was more common in the group having fotemustine as a drip into a vein.

People in the group having treatment into an artery had more liver problems and tummy (abdominal) pain. They also had a lot of problems with the thin tube (catheter) that went into the artery. The problems included getting blood clots and the tube narrowing or getting blocked. 2 people in this group had an extremely severe infection and died as a result.

The trial team concluded that although the cancer responded better to fotemustine treatment into an artery, it did not help people to live for longer after treatment and caused some very serious side effects.

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.