
Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.
This trial looked at lapatinib for advanced bladder cancer. It was for people:
Cancer Research UK supported this trial.
Chemotherapy is the usual treatment for bladder cancer that has spread elsewhere in the body (advanced bladder cancer). Researchers are looking at ways to stop or delay the cancer growth after chemotherapy finishes. In this trial, they looked at a drug called lapatinib (Tyverb).
Lapatinib is a type of targeted cancer drug (or ) called a tyrosine kinase inhibitor. Tyrosine kinases are proteins that stimulate cancer cells to grow. Lapatinib blocks the HER1 (also known as epidermal growth factor receptor or EGFR) and HER2 proteins. This stops the signals that cancer cells use to divide and grow.
Doctors hoped that giving lapatinib after initial chemotherapy might delay or stop cancer growth. But they weren’t sure so wanted to find out more.
In this trial, some people had lapatinib after chemotherapy and some had a dummy drug ().
The aim of this trial were to:
The trial team found having lapatinib after chemotherapy wasn’t a useful treatment for advanced bladder cancer that has large amounts of HER1 or HER2.
446 people who had between 4 and 8 cycles of chemotherapy for urothelial bladder were screened to see if they were suitable to join the trial. The researchers tested a sample of their tissue () taken previously to check if their cancer tested positive for HER1 or HER2.
232 people tested positive for these proteins and fitted the other for the trial. They joined the trial and were put into 1 of the following 2 treatment groups at
:
Neither the people taking part nor the doctor knew which treatment they were having. This is called a double blind trial.
Everyone had treatment for as long as it worked and the side effects weren’t too bad.
The researchers compared the treatments. They looked at how long people lived:
They didn’t find a significant difference in either of these.
The researchers looked in more detail at people’s HER status. Even those who tested strongly positive for HER1 and HER2 showed no benefit.
The number of people who had to stop treatment due to bad side effects was similar in both treatment groups. People who had lapatinib had more serious problems that included:
The researchers concluded that having lapatinib after chemotherapy for advanced bladder cancer wasn’t a useful treatment. They say that further works need to be done to find out more about the role of HER1 and HER2 in advanced bladder cancer.
We have based this summary on information from the research team. 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 who did the research. We have not analysed the data ourselves.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Prof Thomas Powles
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
GlaxoSmithKline (GSK)
NIHR Clinical Research Network: Cancer
Queen Mary University of London
This is Cancer Research UK trial number CRUKE/09/002.
Freephone 0808 800 4040
Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.