A trial looking at chemotherapy after surgery for transitional cell cancer of the urinary system (POUT)

The trial team found that having chemotherapy after surgery worked well. It delayed the cancer coming back for longer. And the side effects were manageable.

About this trial
This was a phase 3 trial. It took place in the UK. 261 people took part.

Everyone had surgery to remove their kidney and ureter as planned. They were then put into 1 of 2 treatment groups at random.

• 132 had chemotherapy (group 1).
• 129 had monitoring to check for signs of cancer (group 2).

Neither they nor their doctor could decide which group they were in.

In the chemotherapy group, they had 1 of the following:

• gemcitabine and cisplatin (a platinum drug )
• gemcitabine and carboplatin (another platinum drug)

They had up to 4 cycles of treatment.

People in group 2 could go on to have chemotherapy if their cancer came back. But this wasn’t part of the trial.  

Results
The committee that monitors the safety and design of the trial (the data monitoring committee) did a planned early analysis of the results. This was to check how treatment was working.

The results showed that having chemotherapy worked better than not having chemotherapy. So the trial was stopped early. This was so the trial team could share the results. And people could start chemotherapy if they were suitable to have it. 

The trial team followed everyone up for an average of 30 months. They worked out that having chemotherapy could reduce the risk of dying or of the cancer coming back by just over half (55%). 

The trial team looked at the number of people who were alive and had no signs of cancer. They worked out that at 3 years this could be:

• just over 7 out of 10 people (71%) who had chemotherapy
• just under 5 out of 10 people (46%) who didn’t have chemotherapy

They also looked at the number of people who were alive and whose cancer hadn’t spread elsewhere in the body. They found this was:

• just over 7 out of 10 people (71%) who had chemotherapy
• just over 5 out of 10 people (53%) who didn’t have chemotherapy

The trial team plan to look at how long people live. This is called overall survival. We’ll add these results when they are available.

Quality of life
The trial team looked at how having chemotherapy affected quality of life. Everyone filled in a questionnaire at set times during treatment and afterwards. The questionnaire asked about side effects and how people had been feeling.

They compared the results of the 2 groups. They found people who had chemotherapy had a lower quality of life during chemotherapy. And for up to 3 months afterwards. But their quality of life improved. And by 6 months there was no difference between the 2 groups.

Side effects
The side effects of chemotherapy were as expected. Some of the more serious side effects included:

• an increased risk of infection
• increased risk of bleeding
• feeling and being sick
• a fever and a drop in white blood cells (neutropenia )

The trial team say the side effects were manageable.

Conclusion
The trial team concluded that having chemotherapy after surgery worked well. And that it should be considered as a new standard of care for transitional cell cancer of the kidney and ureter.

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 ) 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.