A trial looking at rucaparib for ovarian cancer after platinum chemotherapy has stopped working (ARIEL3)

Cancer type:

Ovarian cancer

Status:

Results

Phase:

Phase 3

This trial looked at rucaparib for women whose ovarian cancer had got smaller or gone away after platinum chemotherapy.

More about this trial

Ovarian cancer, fallopian tube cancer and primary peritoneal cancer are all similar and are treated in the same way. So when we use the term ovarian cancer in this summary, we are referring to all 3.

Ovarian cancer often responds well to chemotherapy that includes a platinum drug such as carboplatin. But after a while it may start growing again.

In this trial, researchers looked at rucaparib for women whose cancer had got smaller or gone away after at least two courses of platinum chemotherapy.

Rucaparib is a type of targeted cancer drug known as a PARP inhibitor. PARP is an enzyme that helps damaged cells to repair themselves. Cancer cells may not be able to repair themselves if PARP is blocked.

The main aim of this trial was to see whether rucaparib helped stop ovarian cancer coming back after it has responded to platinum chemotherapy.

Summary of results

This trial recruited 564 women with advanced ovarian cancer that had stopped growing or had gone away after treatment with platinum chemotherapy.

The women taking part were put into 1 of 2 groups at random, and:

375 had rucaparib tablets
189 had dummy (placebo) tablets

ARIEL3 diagram

The research team looked at how long it was before the cancer started to grow again, and found it was:

10.8 months for those who had rucaparib
5.4 months for those who had the placebo

When they looked in more detail at women who had a change in a gene called BRCA, it was:

16.6 months for those who had rucaparib
5.4 months for those who had placebo

207 of the women taking part had an area of cancer that could be measured on a scan. The scan results showed that, after treatment, the cancer had got smaller in:

26 out of 141 women (18%) who’d had rucaparib
5 out of 66 women (8%) who’d had the placebo

When the research team analysed the results in 2017, it was a bit too early to see if the women in one group are likely to live longer than the other. They found that about 2 out of 10 women (22%) in each group had died. They will look at this again in future to see if there is any difference between the two groups. We plan to update this page once these results are available.

Most women taking part had some side effects, but many were mild or short term. But more than 5 out of 10 women (56%) who had rucaparib had side effects which were more severe. This is compared to less than 2 out of 10 women (15%) who had the placebo. The most common side effects were:

feeling or being sick
weakness or tiredness
taste changes
a drop in red blood cells
constipation
a change in liver function tests

The research team concluded that rucaparib increased the amount of time before ovarian cancer started to grow again. They suggest that it could be useful for women whose cancer responds to at least two courses of platinum chemotherapy.

We have based this summary on information from the research team. 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 who did the research. We have not analysed the data ourselves.