A trial looking at BCG and hyperthermia treatment for people with transitional cell bladder cancer (HYMN)

Cancer type:

Bladder cancer
Transitional cell cancer

Status:

Results

Phase:

Phase 3

This trial compared standard treatment (including BCG) and hyperthermia treatment for early stage transitional cell bladder cancer that had come back. It was supported by Cancer Research UK. 

This trial was open for people to join between 2010 and 2013, and the research team first published results in 2018.

More about this trial

Doctors usually treat early stage superficial bladder cancer with surgery and BCG treatment. BCG is a treatment you have directly into your bladder. This is called intravesical treatment.

But sometimes the cancer comes back. When this trial was done there was no proven standard treatment available if this happened. One option was to have an operation to remove the bladder (cystectomy). But this is a major operation and was not suitable for everyone. The other option was to have more BCG treatment into the bladder. 

Doctors want to improve treatment for people whose cancer has come back after BCG treatment and who either can’t, or don’t want to, have their bladder removed.

Hyperthermia treatment means that mitomycin C chemotherapy is heated to about 42° Celsius. It is then put directly into the bladder. Research had shown that cells may be able to absorb more chemotherapy if it was heated up. Doctors hoped this would mean it would work better than BCG for bladder cancer.

Some people in this trial had standard treatment. This was either more BCG, or another treatment. And some had hyperthermia treatment with mitomycin C.

The aims of this trial were to find out:

  • which treatment works best for early stage bladder cancer that had come back
  • more about the side effects
  • more about quality of life

Summary of results

The research team found there wasn’t much difference in how well hyperthermia treatment and other treatments worked for most people with bladder cancer.

Trial design
A total of 104 people who had already had BCG for bladder cancer joined this trial. The team had hoped to recruit more people, but closed the trial earlier than planned. This was because the hyperthermia treatment wasn’t working as well as they’d hoped. 

About 7 out of 10 people taking part had very early bladder cancer called carcinoma in situ, or CIS. Areas of CIS are flat and don’t grow through the bladder wall.  But they are more likely to grow quickly and come back after treatment than other bladder cancers.

About 3 out of 10 people taking part had a type of early stage bladder cancer called papillary bladder cancer. This appears as small growths that grow out from the bladder lining. They often grow more slowly and are less likely to spread.

About 2 out of 10 people taking part had both CIS and papillary cancer.

Everyone taking part was put into 1 of 2 treatment groups at random.

56 people had standard treatment:

  • 18 people with papillary cancer 
  • 28 people with CIS
  • 10 people with papillary cancer and CIS 

48 people had hyperthermia treatment with mitomycin C:

  • 15 people with papillary cancer 
  • 21 people with CIS
  • 12 people with papillary cancer and CIS

Results
The research team looked at how many people were free from cancer 2 years after joining the trial.  

When they looked at the results overall, they found there wasn’t much difference between the two treatment groups. 

The number of people who were free from cancer was:

  • more than 4 out of 10 people (41%) who had standard treatment
  • more than 3 out of 10 people (35%) who had hyperthermia treatment

They also looked at the results of people with CIS and papillary cancer separately. They found that hyperthermia treatment didn’t work as well for people who had CIS. 

The number of people who were free from cancer 2 years after joining the trial was:

  • nearly 5 out of 10 people (47%) with CIS who had standard treatment
  • more than 2 out of 10 people (21%) with CIS who had hyperthermia treatment
  • more than 2 out of 10 people (22%) with papillary cancer who had standard treatment
  • more than 5 out of 10 people (53%) with papillary cancer who had hyperthermia treatment

But it’s hard to draw any firm conclusions from these figures because the groups were fairly small.

Quality of life
The people taking part completed regular questionnaires about how they were feeling and any side effects they were having. These are called quality of life questionnaires. There wasn’t any difference in the quality of life between the two treatment groups. 

The questionnaires included questions about how they rated their health. People who had hyperthermia treatment tended to rate their health higher than those who had BCG.

Side effects
About 9 out of 10 people (88%) who had hyperthermia treatment and more than 7 out of 10 people (75%) who had standard treatment had at least 1 side effect. But most were mild or didn’t last long.

A small number of people in each group had more serious side effects. 

For people having hyperthermia treatment the more serious side effects included:

  • pain
  • extreme tiredness (fatigue)
  • rash
  • passing blood in their urine

For people who had standard treatment such as BCG, the side effects included:

  • needing to go to the toilet more often during the day and at night
  • extreme tiredness (fatigue)
  • urine infections
  • rash

Conclusion
The research team concluded that there was not much difference between hyperthermia treatment and BCG for bladder cancer that had come back after initial BCG treatment.

They think that hyperthermia treatment may work better for people with papillary cancer than people with CIS. They suggest other trials are done to look at this in more detail.

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.

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Professor John Kelly

Supported by

Cancer Research UK
Kyowa Hakko UK Limited
Medical Enterprises BV
University College London (UCL)
University of Birmingham

Other information

This is Cancer Research UK trial number CRUK/09/012.

Freephone 0808 800 4040

Last review date

CRUK internal database number:

2411

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Cara took part in a clinical trial

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"I am glad that taking part in a trial might help others on their own cancer journey.”

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