A trial looking at the order in which everolimus and sunitinib should be given for advanced kidney cancer (RECORD 3)

Cancer type:

Kidney cancer

Renal cell cancer

Status:

Results

Phase:

Phase 2

This trial compared 2 different orders (sequences) of having everolimus and sunitinib for kidney cancer that had spread to other parts of the body. It was for people who had the most common type of kidney cancer called renal cell cancer.

Doctors often use biological therapy to treat advanced kidney cancer. One of the drugs they may use is called sunitinib. But doctors are looking for new ways to treat people with kidney cancer.

In this trial they compared giving a drug called everolimus (also known as Afinitor) before sunitinib with giving everolimus after sunitinib. Everolimus is also a type of biological therapy. It stops a particular protein called mTOR Open a glossary item from working properly. mTOR controls other proteins that trigger cancer cells to grow. By blocking mTOR, everolimus helps to stop cancer growing.

Some people had sunitinib to begin with and then if their cancer got worse, they stopped that and started everolimus. Some people started treatment with everolimus and then changed to sunitinib if their cancer got worse.

The aims of the study were to

See which was the best order to give everolimus and sunitinib for kidney cancer that had spread
Learn more about the side effects of both treatments and the effect they had on quality of life

Summary of results

The trial team found that giving everolimus before sunitinib didn’t work as well as giving sunitinib before everolimus to treat kidney cancer that had spread.

This was an international phase 2 trial. It was a randomised trial. The 471 people who took part were put into 1 of 2 treatment groups. Neither they nor their doctor could choose which group they were in.

238 people had everolimus first followed by sunitinib
233 people had sunitinib first followed by everolimus

When the researchers looked at the average length of time people lived without any sign of their cancer getting worse they found it was

Just over 8 months for those who had everolimus first then sunitinib
Just under 11 months for those who had sunitinib first then everolimus

When their cancer got worse, just under half of the people in each group followed on with their treatment and changed over to other drug.

The researchers then looked at the average overall length of time people lived, they found it was

Just under 22½ months for those who had everolimus first followed by sunitinib
32 months for those who had sunitinib first followed by everolimus

The most common side effects of both everolimus and sunitinib as first treatments were

Sore mouth
Tiredness (fatigue)
Diarrhoea

The trial team concluded that as a first treatment for kidney cancer that has spread everolimus was not as good as sunitinib. So having sunitinib first followed by everolimus when the cancer got worse should remain the standard treatment Open a glossary item ].

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 (peer reviewed Open a glossary item ) and published in a medical journal. The figures we quote above were provided by the trial team. We have not analysed the data ourselves.