A trial looking at liposomal doxorubicin with or without Yondelis for ovarian cancer (ET743-OVA-301)

Cancer type:

Ovarian cancer

Status:

Results

Phase:

Phase 3

This large trial was for ovarian cancer that had come back after prior chemotherapy that included a platinum drug. It was comparing liposomal doxorubicin alone with the combination of liposomal doxorubicin (also called Caelyx or Doxil) and Yondelis (also called ET743 or trabectedin).

Doctors usually treat ovarian cancer with surgery and platinum chemotherapy. But sometimes chemotherapy only works for a short time and then the cancer starts to grow again (recurs or relapses).

Liposomal doxorubicin is one of the chemotherapy drugs used to treat ovarian cancer that has come back. Researchers wanted to find out if adding a drug called Yondelis would help women whose ovarian cancer had come back after earlier treatment.

The aims of this trial were to

Find out if liposomal doxorubicin with Yondelis is more effective than liposomal doxorubicin alone for ovarian cancer that had come back
Learn more about the side effects and what happened to the drugs in the body

Summary of results

The researchers found that having both drugs increased the amount of time women were living without any sign of the cancer growing again.

663 women had treatment in this trial
Half had liposomal doxorubicin and Yondelis
Half had liposomal doxorubicin alone

The researchers looked at how many women responded to treatment. With the combination of both drugs, the cancer responded in 28% of women. With liposomal doxorubicin alone, the cancer responded in 19% of women. By response, they mean the tumour had got smaller or disappeared.

1 in 5 of the women (20%) who had liposomal doxorubicin alone had severe hand foot syndrome, and more than 1 in 10 (11%) had a severe sore mouth. In the group having both drugs, fewer women had these side effects, but more of them had sickness and more severe drops in their blood counts

During follow up, the researchers found the average length of time that women were living without any sign of their cancer growing again was 7.3 months in the group having both drugs and 5.8 months in the group having liposomal doxorubicin alone.

The researchers found that the combination of both drugs was most helpful for women whose cancer had come back 6 months after platinum chemotherapy. For these women, the average length of time before the cancer started growing again was 9.2 months in the group who had both drugs, and 7.5 months in the group who had liposomal doxorubicin alone.

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 ) but may not have been published in a medical journal. The figures we quote above were provided by the trial team. We have not analysed the data ourselves.