Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.
A trial looking at lapatinib with chemotherapy for cancer of the food pipe and stomach (LEO)
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
More about this trial
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
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
- lapatinib for 10 days
- 3 cycles of treatment with oxaliplatin, capecitabine and lapatinib
- surgery to remove either their food pipe (oesophagectomy) or their stomach (gastrectomy)
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
The research team took tissue samples of the cancer (
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
- 5 out of 10 people’s cancer (50%) stopped growing (doctors call this
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 (
How to join a clinical trial
Dr Hugo Ford
Cambridge University Hospitals NHS Foundation Trust
Experimental Cancer Medicine Centre (ECMC)
Medical Research Council
NIHR Clinical Research Network: Cancer