A trial of olaparib with chemotherapy for advanced ovarian cancer

Cancer type:

Ovarian cancer

Status:

Results

Phase:

Phase 2

This trial looked at having olaparib in combination with chemotherapy followed by olaparib on its own.

It was for women with the most common type of ovarian cancer (high grade Open a glossary item serous type epithelial ovarian cancer) that had come back after treatment with a platinum drug .

This trial closed in 2010. These results were published in 2015.

More about this trial

Doctors usually treat cancer of the ovary with surgery, often followed by chemotherapy. Chemotherapy for ovarian cancer usually contains a platinum drug Open a glossary item such as carboplatin.

If ovarian cancer comes back after chemotherapy, you might have more chemotherapy. If your cancer had responded to a platinum drug the first time, you might have a platinum drug again.
This trial was for women who had ovarian cancer that had responded to a platinum drug before. Some of the women taking part also had a drug called olaparib.

Olaparib is a type of targeted cancer drug called a PARP inhibitor.

Every cell contains DNA. This is the genetic information that controls how cells behave. If DNA becomes damaged (as in cancer cells), a protein called PARP-1 helps to repair it. Olaparib stops PARP-1 from working. If PARP-1 doesn’t work, cancer cells can’t repair themselves and they die.

The aims of the trial were to:

see if a combination of olaparib and chemotherapy followed by olaparib on its own worked better than chemotherapy alone for women with advanced ovarian cancer
learn more about the side effects of having olaparib and chemotherapy together

Summary of results

The trial team found that women who had olaparib and chemotherapy lived longer without a sign of their cancer than women who had chemotherapy only.

About this trial
This was a phase 2 trial. It was a randomised trial. 162 women agreed to take part. Before starting treatment 6 women decided not to continue in the trial. The remaining 156 women were put into 2 groups:

81 had olaparib with paclitaxel and carboplatin followed by olaparib on its own
75 had paclitaxel and carboplatin

Diagram 1

After completing their chemotherapy the women who had taken olaparib continued taking it.

Results
The trial team looked at the median Open a glossary item length of time women lived without a sign of their cancer. After a median follow up of:

just under 10 months (9.8 months) for women who had olaparib and chemotherapy followed by olaparib on its own
7½ months for women who had chemotherapy only

They found it was:

just over a year (12.2 months) for women who had olaparib and chemotherapy
just over 9½ months for women who had chemotherapy only

Bar Chart 1

After a median follow up just under 34 months (33.4) in the olaparib and chemotherapy group and of just over 32 months (32.2) for the chemotherapy group, the team looked at the length of time the women lived (their overall survival). They found there was no significant difference between the 2 groups.

BRCA gene mutation
The team looked at a subgroup of women whose ovarian cancer had a BRCA gene change (mutation Open a glossary item ).

In the olaparib and chemotherapy group, 20 women had a BRCA change.

In the chemotherapy only group, 21 women had a BRCA change.

The team found that the average length of time these women lived without sign of cancer was significantly better than those who didn’t have a BRCA change.

But their overall survival wasn’t any better.

Side effects
About 10 out of every 100 (10%) of the women who had olaparib with chemotherapy had more side effects than women who had chemotherapy only.

The most common side effects were:

hair loss
feeling sick
a drop in white blood cells
diarrhoea
headache
numbness and tingling in the hands and feet
indigestion

Conclusion
The team concluded that:

olaparib with paclitaxel and carboplatin followed by continuing with olaparib worked better than paclitaxel and carboplatin only
this combination was acceptable with side effects that can be well controlled
women whose ovarian cancer had a BRCA gene change seemed to have the greatest benefit

Three other phase 3 trials, SOLO1, SOLO2 and SOLO3 also looked at the benefit of olaparib for women whose ovarian cancer has a BRCA change.

Where this information comes from
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.