A trial of cabazitaxel and cisplatin before surgery to remove invasive bladder cancer (Bristol Bladder Trial)

Cancer type:

Bladder cancer

Transitional cell cancer

Status:

Results

Phase:

Phase 2

This trial looked at how well cabazitaxel and cisplatin worked for bladder cancer before surgery to remove it.

It was for people with a type of bladder cancer called transitional cell cancer.

This trial was open for people to join between 2012 and 2017. The team published the results in 2021.

More about this trial

Invasive bladder cancer is cancer that has grown into the muscle layer of the bladder. One of the main treatments is surgery to remove the bladder.

When this trial was done research showed that having chemotherapy before surgery helped. It lowered the risk of the cancer coming back. It was usual to have a chemotherapy drug called cisplatin and another drug such as gemcitabine.

In this trial, doctors looked at the combination of cisplatin and a chemotherapy drug called cabazitaxel. It was a newer drug when researchers ran this trial. They thought it might improve treatment. But they weren’t sure so wanted to find out more.

The main aims of the trial were to:

find out how well this drug combination works for invasive bladder cancer before surgery
learn more about the side effects

Summary of results

The trial team found that having cabazitaxel and cisplatin before surgery worked. And the side effects of the combination of chemotherapy were manageable.

Trial design
This phase 2 trial took place in the UK.

26 people joined the trial. Everyone had up to 4 cycles Open a glossary item of cisplatin and cabazitaxel. This was followed by surgery to remove the bladder. This type of surgery is a radical cystectomy.

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Results
The trial team looked to see who had completed all 4 cycles of chemotherapy. They found that it was nearly 8 out of 10 people (78%).

The team then looked at the total number of people who had no signs of cancer at surgery or it had shrunk. This happened in 15 out of the 26 people (57.7%).

Of those, the cancer:

went away completely in 9 people
got smaller in 6 people. There were no signs of cancer in the muscle layer of the bladder.

The team also looked at whose cancer got worse and spread to other parts of the body. This happened in:

1 person during chemotherapy
6 people after surgery

The trial team looked at:

whose cancer came back again after surgery
how long people lived

The team have this information for people whose cancer didn’t get smaller after chemotherapy. In this group:

the cancer came back and spread to other parts of the body after about 7.2 months
people lived for about 16.9 months

For people whose chemotherapy worked, the team could not calculate these values. This is because when the team did the analysis the cancer hadn’t come back in anyone. And all the people in this group were living.

Side effects
The team found that the side effects of cabazitaxel were manageable. And that most of the side effects of the combination of chemotherapy were mild to moderate.

The most common side effects of the combination included:

feeling or being sick
constipation
tummy pain
tiredness (fatigue)

A few people needed to have their chemotherapy delayed or the dose reduced. Dose reductions for cabazitaxel happened in 4 people. And in 6 people for cisplatin.

A few people had bad side effects but they got better in most people.

The team also looked at the length of hospital stay after surgery. And any possible complications from surgery. Some people did have side effects or complications following their operation but no more than you would expect.

Conclusion
The trial team found that having cabazitaxel and cisplatin before surgery worked well for bladder cancer. And the side effects of this combination of chemotherapy weren’t too bad.

The team compared the results of this trial with people who had standard treatment. This was with gemcitabine and cisplatin. They compared results to see whose cancer went away completely. The researchers think that cabazitaxel and cisplatin worked better. But this was a small trial so it’s important to run a bigger trial to confirm these findings.

The team recommend that this combination of chemotherapy is looked at in a larger trial. They hope to run one at some point in the future.

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.