A trial comparing BEP and Taxol-BEP chemotherapy for male germ cell tumours (MRC TE21, EORTC 30983)

Cancer type:

Testicular cancer

Status:

Results

Phase:

Phase 3

This trial looked at BEP chemotherapy with or without paclitaxel (Taxol) for male germ cell tumours.

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

Doctors often treat germ cell cancers with surgery if it is in the testicle or chemotherapy if it is somewhere else in the body. They usually give a combination of chemotherapy called BEP. This is bleomycin, etoposide and cisplatin.

BEP often works very well. But doctors are always keen to improve treatments. They thought that adding a drug called paclitaxel (Taxol) may have been better for germ cell tumours classed as ‘intermediate prognosis’. There are 2 main types of germ cell tumour. Intermediate prognosis for seminoma germ cell tumour means that the tumour has spread beyond the lung and lymph nodes. Intermediate prognosis for non seminoma germ cell tumours means that the tumour started in your testicle or abdomen. It may have spread to the lungs or lymph nodes, but no further. Paclitaxel is a drug that doctors sometimes use after other treatments such as BEP, or for more advanced germ cell tumours. They do not currently use it at the same time as BEP, or for this group of patients.

The aim of this trial was to compare BEP with Taxol-BEP (T-BEP) to see which was better for intermediate prognosis germ cell tumours and to find out more about the side effects of this combination of treatment.

Summary of results

The trial team found that Taxol-BEP (T-BEP) seemed to be safe and may help to stop intermediate prognosis germ cell tumours coming back.  

This was a randomised trial. The people taking part were put into 1 of 2 treatment groups. Neither they nor their doctor could choose which group they were in.  

People in the first group had BEP. People in the second group had T-BEP.  

The trial team intended to recruit 498 people. Unfortunately the trial didn’t recruit as well as they thought it would. They recruited a total of 337 people.  Of these

  • 169 had BEP
  • 168 had T-BEP

After an average follow up of just over 5 years the trial team looked at the number of people whose germ cell tumour had not come back. This was the case in 

  • Just under 80 out of every 100 people (80%) who had T-BEP
  • Just over 71 out of every 100 people (71%) who had BEP

Included in these 337 people were 26 people whose germ cell tumour was not intermediate prognosis. The research team took these 26 people out and looked again at the number of people whose germ cell tumour had not come back. This was the case in

  • Just under 83 out of every 100 people (83%) who had T-BEP
  • Just over 70 out of every 100 people (70%) who had BEP

The trial team stated that these figures showed T-BEP was better and that they were unlikely to have happened by chance (they were statistically significant Open a glossary item).

The trial team found no difference between the groups when they looked at the overall number of people who were alive after an average follow up of 5 years.

There were very few severe side effects in either group. The most common side effects reported by both groups were

The team accepted that the trial didn’t recruit as well as they hoped and so the results were not as conclusive as they had hoped. It also included some people whose tumour wasn’t of intermediate prognosis. But they concluded that T-BEP seemed to be safe and may have helped to treat intermediate prognosis germ cell tumour.  

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.

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Dr R de Wit

Supported by

European Organisation for Research and Treatment of Cancer (EORTC)
Experimental Cancer Medicine Centre (ECMC)
Medical Research Council (MRC)
National Institute for Health Research Cancer Research Network (NCRN)

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

360

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Ashley was diagnosed with testicular cancer when he was 28

A picture of Ashley

"I now know how cancer can strike anyone whatever their situation or circumstance. I hope by taking part in a trial it will help others in my position in the future.”

Last reviewed:

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