A trial comparing chemotherapy and bevacizumab with chemotherapy alone and a feasibility study looking at lapatinib for HER2 positive cancer (ST03)

Cancer type:

Oesophageal cancer
Stomach cancer

Status:

Results

Phase:

Phase 2/3

This trial compared chemotherapy and bevacizumab with chemotherapy on its own as a treatment both before and after surgery. It was open to people
with:

At some hospitals another part of the trial looked at lapatinib for people who had cancer that was HER2 positive Open a glossary item. This part was a feasibility study

Cancer Research UK supported this trial.

More about this trial

The standard treatment of chemotherapy and surgery for stomach cancer can lower the risk of the cancer coming back. 

In the main part of the trial, the trial team compared having chemotherapy on its own with having chemotherapy and bevacizumab. Everyone had either:

  • chemotherapy on its own before and after their surgery or
  • chemotherapy and bevacizumab before and after their surgery

Bevacizumab (Avastin) is a type of targeted cancer drug called a monoclonal antibody. It targets a protein on the cells called vascular endothelial growth factor (VEGF). 

This protein helps cancers to grow blood vessels, so they can get food and oxygen from the blood. All cancers need a blood supply to be able to survive and grow. 

Bevacizumab blocks this protein and stops the cancer from growing blood vessels, so it is starved and won’t be able to grow.

Researchers thought that having bevacizumab as well as chemotherapy may be better than chemotherapy on its own. But they weren’t sure. 

All treatments have side effects, and it is important that people don’t have treatment they don’t need.

The aims of the main trial were to:

  • find out if adding bevacizumab to chemotherapy worked better than chemotherapy on its own for stomach cancer and oesophageal cancer
  • learn more about the side effects

In the feasibility study, some people had lapatinib with their chemotherapy.

Some stomach cancer cells have large amounts of a protein called HER2.

Lapatinib is a type of targeted cancer drug. It is a cancer growth blocker. It stops signals that cancer cell use to divide and grow.

The aims of the feasibility study were to:

  • find out how common HER2 positive stomach or oesophageal cancer was
  • see if lapatinib with chemotherapy helped people with HER2 positive cancer

Summary of results

These results are for the main trial comparing chemotherapy on its own with chemotherapy and bevacizumab. 

The trial team found that adding bevacizumab to chemotherapy wasn’t any better than chemotherapy on its own for:

  • stomach cancer                
  • oesophageal cancer   
  • gastro oesophageal junction cancer        

The main trial was open to people to join between 2007 and 2014. These results were published in 2017. 

The team are still looking at the results for the feasibility study of lapatinib. When these results are published we will update this summary. 

About this trial
This main trial was a phase 2/3 trial. 1,063 people took part. They were put into 1 of 2 treatment groups at random

  • 533 people had chemotherapy only
  • 530 people had chemotherapy and bevacizumab


Results
Of the 1,063 people who joined the trial, 1,054 had the trial treatment.

  • 529 people were in the chemotherapy group
  • 525 people were in the chemotherapy and bevacizumab group 

Survival
After an overall average follow up of just over 3 years (38.4 months) the total number of people who had died was 508.

  • 248 people in the chemotherapy only group
  • 260 people in the chemotherapy and bevacizumab group

At 3 years follow up the team found there was little difference in the percentage of people who had survived in each group. It was:

  • just over half (50.3%) for those in the chemotherapy only group
  • just under half (48.1%) for those in the chemotherapy and bevacizumab group

How well treatment worked
To find out how well each treatment worked the team were able to look at the results of 875 people.

  • 438 people in the chemotherapy only group
  • 437 people in the chemotherapy and bevacizumab group

The number of people who didn’t have any sign of their cancer (complete response) was:

  • 21 people (5%) in the chemotherapy only group
  • 11 people (3%) in the chemotherapy and bevacizumab group


The number of people whose cancer had shrunk (partial response) was:

  • 162 people (37%) in the chemotherapy only group
  • 166 people (38%) in the chemotherapy and bevacizumab group

The number of people whose cancer stayed the same (stable disease) was:

  • 224 people (51%) in the chemotherapy only group
  • 228 people (52%) in the chemotherapy and bevacizumab group

Side effects
Side effects were similar in both groups. The most serious side effects included:

  • a drop in the white blood cells
  • leaking from where the stomach and or food pipe was joined back together after the cancer was removed 
  • infection without a drop in the white blood cells 

The number of people who had problems with how their wound healed after surgery was higher in the chemotherapy and bevacizumab group than those who had chemotherapy only. 

Conclusion
The trial team concluded that adding bevacizumab to chemotherapy didn’t increase the amount of time people lived after having surgery to remove their stomach cancer or oesophageal cancer. 

Bevacizumab might also be linked to poor wound healing after surgery. 

This hasn’t changed the way these people are treated. But continuing to assess new drugs helps to improve the outcomes for people with these cancers. 

Where this information comes from    
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.

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

Professor David Cunningham

Supported by

Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
GlaxoSmithKline (GSK) 
Novartis
Medical Research Council (MRC)
NIHR Clinical Research Network: Cancer
Roche

Other information

This is Cancer Research UK trial number CRUK/06/025.

Freephone 0808 800 4040

Last review date

CRUK internal database number:

703

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

Charlie took part in a trial to try new treatments

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“I think it’s really important that people keep signing up to these type of trials to push research forward.”

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