A trial of bevacizumab and chemotherapy for children and teenagers with soft tissue sarcoma (BERNIE)

Cancer type:

Children's cancers

Sarcoma

Soft tissue sarcoma

Status:

Results

Phase:

Phase 2

This trial looked at a drug called bevacizumab (also known as Avastin) and chemotherapy for soft tissue sarcoma. It was for children and young adults up to the age of 18 who:

had soft tissue sarcoma that had spread to other parts of the body (metastatic)
were going to have treatment for metastatic soft tissue sarcoma for the first time

We use the term ‘you’ in this summary, but if you are a parent, we are referring to your child.

More about this trial

Chemotherapy is a treatment for soft tissue sarcoma that has spread to other parts of the body. You usually have it with either (or both):

In this trial, researchers wanted to see if adding a drug called bevacizumab to chemotherapy, is better than chemotherapy alone.

Bevacizumab is a targeted cancer drug called a monoclonal antibody. It works by blocking a protein called vascular endothelial growth factor (VEGF) that helps cancers to make new blood vessels.

The aim of this trial was to see if bevacizumab with chemotherapy is better than chemotherapy alone for children and young adults with metastatic soft tissue sarcoma.

Summary of results

The trial team concluded that adding bevacizumab to chemotherapy in children and young adults with soft tissue sarcoma that has spread didn’t work any better than chemotherapy alone.

This was a phase 2 trial. 154 children and young adults with metastatic soft tissue sarcoma took part. Everyone was having treatment for the first time, after their cancer spread to other parts of the body.

This was a randomised trial. Everyone was put into 1 of the following treatment groups by computer:

80 children and young adults had chemotherapy
74 children and young adults had chemotherapy and bevacizumab

Neither they nor their doctor could choose which group they were in.

study diagram

Everyone had chemotherapy in cycles of treatment. The number of treatments people had, depended on their needs and the side effects. On average, children and young adults had treatment for about 18 months.

The trial team looked at how well bevacizumab worked. To do this, they looked at the average amount of time people lived without any signs of their cancer getting worse. They found it was:

almost 15 months (14.9 months) in the chemotherapy group
about 20 and a half months (20.6 months) in the chemotherapy and bevacizumab group

The team also looked at the most common side effects. They were:

a drop in the number of blood cells causing an increased risk of infection, breathlessness and bleeding
decreased appetite
low levels of potassium in the blood
mouth sores

The side effects were similar in both groups.

The team thinks that this trial did not show strong evidence that adding bevacizumab to chemotherapy improves the average amount of time people live without any signs of their cancer getting worse. In other words, it wasn’t statistically significant Open a glossary item .

They also concluded that chemotherapy with bevacizumab is a safe treatment for children and young adults.

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