A trial comparing brostallicin with doxorubicin for advanced soft tissue sarcoma (EORTC 62061)

Cancer type:

Sarcoma

Soft tissue sarcoma

Status:

Results

Phase:

Phase 2

This trial compared brostallicin with doxorubicin for soft tissue sarcoma that could not be completely removed by surgery, or had spread.

Surgery is the main treatment for soft tissue sarcoma. But sometimes it is not possible to remove the sarcoma completely, or it may have spread to other parts of the body (metastatic sarcoma). In this situation, doctors usually suggest chemotherapy. The drug they use most often is called doxorubicin.

Brostallicin is also a chemotherapy drug. When this trial was done it had already been looked at in trials for people who had soft tissue sarcoma that had come back after having other chemotherapy. But doctors wanted to see if brostallicin helps people who have not already had chemotherapy.

The people taking part could not have surgery or radiotherapy to treat their sarcoma, and had not had chemotherapy since their sarcoma had spread. In this trial, some people had doxorubicin and some people had brostallicin.

The aim of this trial was to see if brostallicin works better than doxorubicin for advanced soft tissue sarcoma.

Summary of results

The trial team found that brostallicin was not better than doxorubicin for advanced soft tissue sarcoma.

This trial recruited 118 people who had advanced soft tissue sarcoma that couldn’t be removed with surgery. They were put into 1 of 2 treatment groups at random. For every 2 people in the brostallicin group there was 1 person in the doxorubicin group, so

79 people had brostallicin
39 people had doxorubicin

The research team were able to look at how well the treatment had worked for most people who took part. They found that, after 6 months of treatment, the cancer had not grown in

5 out of 77 people (6%) who had brostallicin
10 out of 36 people (28%) who had doxorubicin

When they looked at how many people were living at least a year after treatment, they found there was not much difference between the 2 groups. It was about

5 out of 10 people who had brostallicin
6 out of 10 people who had doxorubicin

Both treatments caused some side effects. The most common side effect was a drop in white blood cells which causes an increased risk of infection. This affected most people who had doxorubicin (95%), and 2 out of 3 people who had brostallicin (67%).

Other side effects included tiredness (fatigue), weight loss and hair loss. More people in the doxorubicin group had a sore mouth (mucositis) and hair loss. And more people in the brostallicin group had pain from their sarcoma.

The research team concluded that brostallicin was not as good as doxorubicin for advanced soft tissue sarcoma. They didn’t feel they could recommend it as a first treatment for this group of patients.

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.