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

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:

• 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 chest infection .

The research team took tissue samples of the cancer (biopsy ) 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  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 )
• 5 out of 10 people’s cancer (50%) stopped growing (doctors call this stable disease )

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 ) 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.