A trial looking at sorafenib after surgery for kidney cancer that had not spread (SORCE)

Cancer type:

Kidney cancer

Renal cell cancer

Status:

Results

Phase:

Phase 3

This trial compared sorafenib with a dummy tablet (placebo) after surgery for renal cell cancer (kidney cancer) that had not spread. It was supported by Cancer Research UK.

The trial was open for people to join between 2007 and 2013, and the team published the results in 2020.

More about this trial

Renal cell cancer is the most common type of kidney cancer. Surgery is the main treatment for renal cell cancer that has not spread. This often works very well, but there is a risk that the cancer may come back or spread to another part of the body.

Sorafenib (Nexavar) is a type of targeted cancer treatment called a tyrosine kinase inhibitor (TKI). It stops the signals cancer cells use to divide and grow.

Doctors hoped sorafenib may help stop kidney cancer coming back after surgery.

The main aims of the trial were to find out:

if sorafenib after surgery can help to stop kidney cancer coming back
more about the side effects
if sorafenib does help, whether it is best to have it for 1 year or 3 years

Summary of results

The research team found that taking sorafenib for 1 year or 3 years didn’t help stop kidney cancer coming back after surgery.

Trial design
The people taking part in this trial had kidney cancer that had not spread to another part of the body. They’d all had surgery to remove their cancer.

There were 3 treatment groups in the trial:

Group A had a dummy drug (placebo ) for 3 years
Group B had sorafenib for 1 year and then the placebo for 2 years
Group C had sorafenib for 3 years

They took either placebo or sorafenib tablets every day for up to 3 years.

Results
A total of 1,711 people joined this trial. They were put into 1 of the 3 treatment groups at random Open a glossary item . There were:

430 people in Group A (placebo)
642 people in Group B (sorafenib then placebo)
639 people in Group C (sorafenib)

710_sorce.png

The research team looked at whether the cancer started to grow again and how long people lived for. They found they were very similar in the 3 groups.

The number of people whose cancer had not started to grow again 10 years after starting treatment was more than 5 out of 10 (50%) in each group:

54% for Group A
55% for Group B
53% for Group C

The number of people living 10 years after starting treatment was about 7 out of 10 (70%) in each group:

69% for Group A
69% for Group B
70% for Group C

Side effects
Nearly everyone taking part had at least 1 side effect. Some were mild or didn’t last long. But just over 2 in 10 people who had sorafenib had at least 1 more serious side effect.

The most common of the more serious side effects were high blood pressure and redness or peeling on hands or feet (hand-foot syndrome).

Conclusion
The trial team concluded that taking sorafenib for 1 year or 3 years did not help stop renal cell cancer coming back after surgery.

They don’t recommend that it’s used for this group of patients. But even when a trial shows a treatment isn’t useful for a particular cancer, it adds to our knowledge and understanding of cancer and how to treat it.

Where this information comes from
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.