A trial looking at temozolomide for rhabdomyosarcoma (VIT-0910)

The team found that adding temozolomide to vincristine and irinotecan improved treatment. Some of the side effects were worse but the team say these were manageable. 

Trial design
This was a phase 2 trial. 120 people took part. The median  age was 11 years old.

People were put into a treatment group at random: 

• 60 people had vincristine and irinotecan (VI group)
• 60 people had vincristine, irinotecan and temozolomide (VIT group)

Diagram 1

Everybody taking part had up to 12 cycles of treatment  for as long as it was working and the side effects weren’t too bad. Each cycle of treatment was 3 weeks. 

Results
The trial team followed everyone up for about 57 months. They looked at how well treatment worked. 

In the vincristine and irinotecan group the researchers had the results for 58 people. They found the cancer:

• went away completely in 4 people
• shrunk a little bit in 18 people
• stayed the same in 17 people
• got worse in 19 people

In the VIT group the researchers had the results for 58 people. They found the cancer:

• went away completely in 9 people
• shrunk a little bit in 24 people
• stayed the same in 16 people
• got worse in 9 people

The researchers looked at how long before the cancer started to grow again. They found it was:

• 3.2 months for those who had vincristine and irinotecan
• 4.7 months for those who had vincristine, irinotecan and temozolomide

Graph 1

They also looked at how long people lived. They found it was:

• 10.3 months for those who had vincristine and irinotecan
• 15 months for those who had vincristine, irinotecan and temozolomide

Graph 2

Side effects
Everybody had at least one side effect. The most common severe side effects were:

• a drop in white blood cells  causing an increased risk of infection
• a drop in red blood cells  causing tiredness and breathlessness
• high temperature and low white blood cells (febrile neutropenia)
• diarrhoea
• feeling or being sick 
• weight loss

A few more people who had VIT had these side effects. 

We have information about:

• vincristine
• irinotecan
• temzolomide

Conclusion
The team concluded that temozolomide, vincristine and irinotecan improved treatment for rhabdomyosarcoma that had come back. It increased the length of time that people lived.

Vincristine, irinotecan and temozolomide may now be the new standard treatment  for this group of people.

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.