A trial of gefitinib (Iressa) for advanced synovial sarcoma (EORTC 62022)

Cancer type:

Soft tissue sarcoma




Phase 2

This trial looked at gefitinib (Iressa) for synovial sarcoma that was locally advanced or had spread to another area of the body.

Synovial sarcoma is a type of soft tissue sarcoma. Doctors usually treat it with surgery, sometimes followed by radiotherapy. But sometimes this treatment doesn’t work very well and the sarcoma starts to grow again, or spreads to another part of the body (metastasises). When this happens it is called advanced sarcoma and is more difficult to treat. Doctors may offer chemotherapy to help control the cancer. But in time, it will start to grow again.

Gefitinib is a type of drug called a tyrosine kinase inhibitor (TKI). Cells have ‘epidermal growth factor receptors’ (EGFR) on them. When these receptors are triggered, it sets off a chain of events that tells the cell to grow and divide. Gefitinib blocks tyrosine kinase, which is part of this process.

If gefitinib can stop tyrosine kinase from working, it could stop the cancer from growing. But as this is a relatively new treatment, doctors were not sure how well it would work for synovial sarcoma.

The aims of this trial were to

  • See how well gefitinib works for advanced synovial sarcoma
  • Find out more about the side effects

Summary of results

The research team found that gefitinib did not help patients with advanced synovial sarcoma.

46 patients with advanced synovial sarcoma were recruited on to the trial. They all had cancer that was no longer responding to chemotherapy. They were all treated with gefitinib

  • The cancer did not disappear (complete response Open a glossary item) or get smaller (partial response Open a glossary item) in any of the patients
  • 6 weeks after treatment started, the cancer had continued to grow in 32 patients (70%)
  • In 10 patients (22%) there was no change in the size of the cancer (stable disease Open a glossary item)
  • 3 months after treatment started, only 5 patients had stable disease

The research team felt the side effects were mostly mild and well tolerated. The most common side effects included diarrhoea, skin rash, feeling sick (nausea) and tiredness (fatigue).

They concluded that gefitinib should not be used on its own to treat synovial sarcoma. But they suggested that it may still have a role in combination with other treatments in the future.

We have based this summary on information from the team who ran the trial. 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. 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

Dr M Leahy

Supported by

European Organisation for Research and Treatment of Cancer (EORTC)

If you have questions about the trial please contact our cancer information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle - 466

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

Wendy took part in a new trial studying the possible side effect of hearing loss

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"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”

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