A trial looking at lapatinib with chemotherapy for cancer of the food pipe and stomach (LEO)

Cancer type:

Oesophageal cancer
Stomach cancer




Phase 2

This trial looked at lapatinib with chemotherapy for cancer of the food pipe (oesophagus) and the stomach that have tested positive to a protein called HER2.

People that took part had lapatinib and chemotherapy before surgery to try to shrink the cancer. This is called neo adjuvant treatment Open a glossary item

More about this trial

Oesophageal and stomach cancer can be treated with chemotherapy and surgery. Doctors can use 2 drugs to treat these cancers:

Lapatinib (also called Tyverb) is a type of targeted cancer drug called a tyrosine kinase inhibitor (TKI). It works by blocking receptors on cancer cells that make them grow. One of the receptors lapatinib blocks is HER2 Open a glossary item.

Researchers think lapatinib may help people with HER2 positive oesophageal and stomach cancer.

The aims of this trial were to find out if:

  • lapatinib can help people with HER2 positive oesophageal and stomach cancer
  • it helps to start lapatinib before chemotherapy

Summary of results

This trial closed early due to a serious side effect that researchers think might have been caused by lapatinib and chemotherapy.

The following people took part:

  • 6 people with cancer of the area where the food pipe meets the stomach (called the oesophageal gastric junction)
  • 3 people with oesophageal cancer
  • 1 person with stomach cancer

Everyone had:

The researchers found that after their surgery 2 out of 10 people (20%) had a rare and serious side effect called anastomotic leak. Normally, this happens to around 5 out of 100 people (5%).

The trial team think this might have been caused by the lapatinib and chemotherapy so they closed the trial earlier than they had planned to.

There were no side effects from the lapatinib alone and the other side effects from lapatinib and chemotherapy were mostly mild. But 1 person with the anastomotic leak unfortunately died after developing a chest infection Open a glossary item.

The research team took tissue samples of the cancer (biopsy Open a glossary item) before and 10 days after starting lapatinib. They found that lapatinib might not work well in people whose cancer cells have high numbers of receptors Open a glossary item called MET. 

They looked at how well lapatinib and chemotherapy worked before surgery. They found that:

  • 5 out of 10 people’s cancer (50%) got smaller (doctors call this a partial response Open a glossary item)
  • 5 out of 10 people’s cancer (50%) stopped growing (doctors call this stable disease Open a glossary item)

The researchers looked at the amount of time people lived overall. They call this overall survival. They found that on average, it was just over 2 ½ years.

They also looked at the average length of time it took before people’s cancer got worse (this is called progression free survival). They found that this was just over 16 months.

The researchers are aware there are other trials looking at lapatinib and chemotherapy before surgery. They suggest that the amount of time between the end of lapatinib and surgery should be longer to see if it reduces the number of people that have anastomotic leaks.    

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. We have been unable to get this summary checked by the trial team.  

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 Hugo Ford

Supported by

Cambridge University Hospitals NHS Foundation Trust
Experimental Cancer Medicine Centre (ECMC)
Medical Research Council
NIHR Clinical Research Network: Cancer

If you have questions about the trial please contact our cancer information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:


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

Last reviewed:

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