A trial looking at axitinib for advanced soft tissue sarcoma (Axi-STS)

Cancer type:

Sarcoma
Soft tissue sarcoma

Status:

Results

Phase:

Phase 2

This trial looked at axitinib for several different types of soft tissue sarcoma that had spread.

The trial was supported by Cancer Research UK. It was open for people to join between 2010 and 2016. The research team analysed the results in 2022.

More about this trial

Doctors often treat soft tissue sarcoma with surgery, radiotherapy, chemotherapy, or targeted cancer treatments. Or a combination of these. But sometimes when soft tissue sarcoma has spread, it can be more difficult to treat. Researchers wanted to find out if axitinib is useful for people in this situation.

Axitinib is a type of targeted cancer treatment called a tyrosine kinase inhibitor (TKI). It stops the signals that tell cancer cells to form their own blood vessels. This can help slow the growth of the cancer, or even shrink it.

The main aims of this trial were to find out:

  • if axitinib can help stop soft tissue sarcoma growing
  • if axitinib can help people live longer
  • more about the side effects of axitinib

Summary of results

This trial was for people with a number of different types of soft tissue sarcoma, including:

  • angiosarcoma
  • leiomyosarcoma
  • synovial sarcoma

They all had cancer that had spread to their lymph nodes or to another part of the body. They took axitinib tablets twice a day, for up to 2 years. 

Results
A total of 145 people joined this trial. They had a number of different types of sarcoma:

  • 38 people had angiosarcoma
  • 37 people had leiomyosarcoma
  • 36 people had synovial sarcoma
  • 34 people had other types of sarcoma

The research team were able to look at how well treatment was working at 3 months for 121 people. The results showed that the sarcoma had:

  • got smaller in 6 people (5%)
  • stayed the same in 54 people (45%)
  • continued to grow in 61 people (50%)

They also looked at how well treatment was working after a year for 136 people. The results showed that:

  • the sarcoma had not grown in 16 people (12%)
  • 54 people (40%) were living

These results are slightly better than you might see with some other treatment options.

Side effects
Everyone taking part had at least one side effect. Many of these were mild or didn’t last long. But some people had a more serious side effect.

The most common side effects were:

  • tiredness
  • raised blood pressure
  • sore or inflamed mouth or bowel lining
  • feeling sick
  • shortness of breath
  • lack of appetite

Conclusion
The trial team concluded that axitinib could help stop advanced sarcoma growing in some people. They also concluded that it didn’t cause too many side effects.

Where this information comes from    
We have based this summary on information from the research team. As far as we are aware, the information they sent us has not been reviewed independently (peer reviewed Open a glossary item) or published in a medical journal yet. The figures we quote above were provided by the research team. 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 Penella Woll

Supported by

Cancer Research UK
Cancer Research UK Clinical Trials Unit Birmingham
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
Pfizer
Sheffield Teaching Hospitals NHS Foundation Trust
University of Sheffield

Other information

This is Cancer Research UK trial number CRUK/09/009.

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 3850

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

Over 60,000 cancer patients enrolled on clinical trials in the UK last year.

Last reviewed:

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