A trial comparing a combination of surgery and sunitinib with sunitinib alone for kidney cancer that has spread (CARMENA)

Cancer type:

Kidney cancer

Renal cell cancer

Secondary cancers

Status:

Results

Phase:

Phase 3

This trial looked at whether surgery and sunitinib or sunitinib alone is better for people with renal cell cancer that has spread to another part of the body.

It was open for people to join between 2009 and 2017, and the team published the results in 2018.

More about this trial

Renal cell cancer is the most common type of kidney cancer. There are several different types of renal cell cancer, the most common is clear cell.

Sunitinib is a type of targeted cancer treatment called a cancer growth blocker. It helps stop signals that cancer cells use to divide and grow.

When this trial was done, some people had surgery to remove their kidney (a nephrectomy), even if the cancer had spread outside the kidney. They then had sunitinib.

Research had shown removing the kidney helped stop the cancer spreading. But it is a big operation. Researchers hoped that sunitinib alone would be as good as surgery followed by sunitinib.

The main aim of this trial was to find out if it is better to have surgery and sunitinib or sunitinib alone, for clear cell renal cancer that has spread.

Summary of results

The research team found that sunitinib alone may be as good as surgery and sunitinib, for people with kidney cancer that had spread.

Trial design
Everyone taking part in this trial had a type of kidney cancer called clear cell renal cell cancer that had spread.

A total of 450 people joined the trial. They were put into 1 of 2 treatment groups at random. There were:

226 in the surgery and sunitinib group
224 in the sunitinib alone group

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The people in the surgery group had their operation within 4 weeks of joining the trial. And then started taking sunitinib about 3 to 6 weeks later.

The people in the sunitinib alone group started taking sunitinib within 3 weeks of joining the trial.

Results
The research team looked at how long it was before the cancer started to grow again. They found it was similar in both groups:

7.2 months for those who had surgery and sunitinib
8.3 months for those who had sunitinib alone

They were able to assess whether the cancer got smaller or not in 386 of the people who took part. They found it got smaller in a similar number of people in both groups:

51 out of 178 people (29%) who had surgery and sunitinib
62 out of 208 people (30%) who had sunitinib alone

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When they looked in 2017 at how many people had died so far, they found this was also similar in both groups:

165 out of 226 people (73%) in the surgery and sunitinib group
161 out of 224 people (72%) in the sunitinib alone group

Side effects
Some people in each group had side effects. A few more people in the sunitinib alone group had more serious side effects:

just over 3 out of 10 (33%) who had surgery and sunitinib
just over 4 out of 10 people (43%) who had sunitinib alone

This could be partly because the people in the sunitinib alone group, on average, took sunitinib for longer than those who had surgery.

The most common side effects were:

weakness and lack of energy (asthenia)
sore hands or feet (hand foot syndrome)
a drop in white blood cells

Most of the side effects affected a similar number of people in both groups. A few more people who had sunitinib alone had problems with their kidney or bladder.

We have more information about the side effects of sunitinib in our Cancer Drugs section.

Nearly 4 out of 10 people (39%) who had surgery had some problems after the operation. This included things such as pain, bleeding or infection. But these were mild for many people. Less than 1 of 10 people (6%) had more serious problems after surgery.

Conclusion
The trial team concluded that sunitinib alone may be as good as surgery and sunitinib for people with kidney cancer that has spread.

There may also be other benefits of not having surgery. These include no risk of complications or side effects from surgery, and being able to start sunitinib sooner.

The team suggest more work is done looking at other targeted therapies for this group of patients.

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.