A trial of cetuximab with chemotherapy and radiotherapy for muscle invasive bladder cancer (TUXEDO)

The trial team found that the combination of cetuximab, chemotherapy and radiotherapy was safe to use. And it could be a useful treatment for bladder cancer that has grown into the bladder wall but not spread. 

Trial design
This trial was for people with bladder cancer that had:

• grown into the bladder wall
• not spread to the lymph nodes
• not spread to another part of the body

Everyone taking part had:

• radiotherapy
• the chemotherapy drugs mitomycin C and fluorouracil (5FU)
• the targeted treatment cetuximab

A total of 30 people joined the trial. This is fewer people than the trial team were hoping. They decided to stop the trial earlier than planned because of the lower number of people joining the trial.

Results
The research team looked at how well the treatment was working 3 months after starting. They found that the cancer had:

• stopped growing, got smaller or gone away in 23 people (77%)
• continued to grow in 7 people (23%)

When they looked at how many people were living 6 months and 1 year after starting treatment, they found it was:

• 29 out of 30 people (97%) at 6 months
• 26 out of 30 people (87%) at 1 year

These results are similar to, or maybe a little better than, results from other treatments. But it’s hard to draw any firm conclusions because of the small number of people in the trial.

Quality of life
People filled out questionnaires that gave a score for their quality if life. The trial team found that these scores went down a bit about a month after treatment. But it went back to the level normal for them by about 3 months after treatment.

Side effects
Everyone taking part had at least one side effect. Many were mild or didn’t last long. But 12 people (40%) had at least one side effect that was more severe.

The most common side effects were:

• diarrhoea
• rash
• extreme tiredness (fatigue)
• feeling sick
• a drop in blood clotting cells (platelets) 

A total of 8 people (27%) stopped cetuximab early because of side effects they were having.

Conclusion
The trial team concluded that the combination of cetuximab, mitomycin C, 5FU and radiotherapy was safe to use. And that it may be a useful treatment for bladder cancer that has grown into the bladder wall. 

They suggest more trials are done looking at chemotherapy, radiotherapy and cetuximab for this group of patients. 

More detailed Information
There is more information about this research in the reference below. 

Please note, this article is not in plain English. It has been written for health care professionals and researchers.

TUXEDO: a phase I/II trial of cetuximab with chemoradiotherapy in muscle-invasive bladder cancer
N James and others
BJU International, published online July 2022.

Where this information comes from
We have based this summary on the information in the article above. This has been reviewed by independent specialists (peer reviewed ) and published in a medical journal. We have not analysed the data ourselves. As far as we are aware, the link we list above is active and the article is free and available to view.