A trial looking at chemotherapy for male germ cell tumours (GAMEC-Short)

Cancer type:

Testicular cancer

Status:

Results

Phase:

Phase 2

This trial looked at giving a shorter course of chemotherapy to see how well it worked for male germ cell tumours. It was for men with a germ cell cancer that had come back or continued to grow after treatment.

More about this trial

Germ cells are the cells that produce sperm. Male germ cell cancers usually develop in the testicles, but can be found in other parts of the body.

Chemotherapy is used to treat germ cell cancer that has come back. For example, a combination of chemotherapy called GAMEC. This includes the drugs

You have these drugs over 2 weeks and every 2 weeks is called a cycle of treatment. You have up to 5 cycles, over 10 weeks. Doctors wanted to find out if men could have a shorter course, called GAMEC-Short. GAMEC is an intensive chemotherapy and can have severe side effects. A shorter course would mean less time in hospital, and possibly less severe side effects.

Some men who were older (over the age of 35) and who had high levels of a hormone called lactate dehydrogenase (LDH) had epirubicin instead of etoposide. This combination of chemotherapy is called GAMEC-A. The A in GAMEC-A refers to epirubicin which belongs to a group of drugs called anthracyclines Open a glossary item .

The aim of this trial was to find out if having 3 cycles of treatment over 6 weeks worked as well having 5 cycles over 10 weeks.

Summary of results

The trial team found that a shorter course of chemotherapy was useful in some people with germ cell cancer.

36 men took part in this phase 2 trial.

There were 2 different treatment groups. Which group men were in depended on whether they had a low risk, or a high risk, of the germ cell tumour coming back.

Low risk means

less than 35 years old
normal levels of a hormone called lactate dehydrogenase (LDH)

High risk means

35 years and older
raised levels of LDH

High risk group
15 men had treatment with 5 cycles of GAMEC-A over 10 weeks.

Low risk group
21 men had GAMEC-S (GAMEC Short). They had 3 cycles over 6 weeks.

26 out of the 36 men who took part (71%) had either a

complete response - this means the disappearance of all signs of cancer for at least four weeks OR
had no signs of any cancer markers

The trial team looked at how many people were alive after 3 years. This was

12 out of 21 men (about 56%) who had had GAMEC-S
3 out of 15 men (about 23%) who had GAMEC-A

Those men who had GAMEC-S were expected to do better because they had a lower risk of their cancer coming back. The researchers concluded that a shorter course of treatment (3 cycles over 6 weeks) could be used for men with low risk germ cell cancer.

The trial team also found that some of the low risk men went on to have high dose chemotherapy and a stem cell transplant. Despite intensive treatment with GAMEC-S, these men were able to have a collection of their stem cells. So if GAMEC-S doesn’t work in some men, further treatment is possible.

The researchers felt that treatment had not improved by replacing etoposide with epirubicin in the GAMEC-A group. They compared the results of this trial with an earlier trial (where men had GAMEC including etoposide). So a change to epirubicin in future treatment is not recommended.

We have based this summary on information from the research team. As far as we are aware, the information they sent us has not been reviewed independently (peer reviewed Open a glossary item ) or published in a medical journal yet. The figures we quote above were provided by the research team. We have not analysed the data ourselves.