A trial looking at chemotherapy with or without panitumumab for advanced cancer of the food pipe (oesophagus) or stomach (REAL3)
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Phase:
This trial looked at chemotherapy with or without panitumumab (Vectibix) for cancer of the oesophagus, stomach or cancer that started where the oesophagus meets the stomach. This is called gastro oesophageal junction cancer. The trial was for people with cancer that had spread into surrounding tissue or to another part of the body (advanced) and who were unable to have surgery. This trial was supported by Cancer Research UK.
Doctors often treat advanced cancers of the oesophagus and stomach with chemotherapy. One combination of drugs they use is called EOX. This is epirubicin, oxaliplatin and capecitabine. In this trial, doctors wanted to see if adding another drug, called panitumumab, was better than having chemotherapy on its own.
Panitumumab is a type of biological therapy called a monoclonal antibody. These can seek out cancer cells by looking for particular proteins. Doctors hoped that blocking these proteins would stop or slow down the growth of cancer cells.
The aims of this trial were to
- Find out if adding panitumumab to chemotherapy for advanced oesophageal and stomach cancer was better than chemotherapy alone
- Learn more about the side effects of panitumumab with this combination of chemotherapy drugs
Summary of results
When the trial team looked at the first results, they found that adding panitumumab to chemotherapy wasn’t any better. So they decided to stop recruiting and closed the trial earlier than they initially planned.
This was a phase 3 trial. It recruited 553 people. It was a randomised trial. The people who took part were put into 1 of 2 treatment groups
- 275 people had EOX
- 278 people had EOX and panitumumab
The researchers looked at CT scans to assess how well people responded to treatment. They were able to look at
- 238 from the EOX group
- 254 from the EOX and panitumumab group
Of the people in the EOX group they found that
- 5 had no sign of their cancer –
complete response - 95 had cancer that had shrunk –
partial response - 51 had cancer that had stayed the same –
stable disease - 19 had cancer that had continued to grow
Of the people in the EOX and panitumumab group they found that
- 8 had no sign of their cancer
- 108 had cancer that had shrunk
- 46 had cancer that had stayed the same
- 30 had cancer that had continued to grow
68 people in the EOX group and 62 people in EOX and panitumumab group didn’t have a scan. This was for a variety of reasons, but was frequently due to the person becoming more unwell during treatment. In general, the trial team considered that these people had not benefited from treatment.
The average overall amount of time that people lived was
- Just over 11 months for those who had EOX
- Just under 9 months for those who had EOX and panitumumab
The researchers didn’t find a significant difference between the side effects of both groups. The most common side effects reported were
- Feeling or being sick
- Sore mouth
- Diarrhoea
- Tiredness
- Tingling, numbness in the hands and feet
- A drop in blood cells
The trial team concluded that the addition of panitumumab to EOX didn’t increase the overall time that people with advanced cancer of the oesophagus and stomach lived.
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 () 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
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Chief Investigator
Professor David Cunningham
Supported by
Amgen
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
National Institute for Health Research Cancer Research Network (NCRN)
The Royal Marsden NHS Foundation Trust
Other information
This is Cancer Research UK trial number CRUKE/07/049.
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040