A study of veliparib with carboplatin and paclitaxel and continued as maintenance treatment for ovarian cancer that has spread

Cancer type:

Ovarian cancer

Secondary cancers

Status:

Results

Phase:

Phase 3

This study looked at having veliparib with chemotherapy and then continuing it as maintenance treatment for ovarian cancer that has spread.

It included women with:

Doctors treat these cancers in a similar way. When we use the term ovarian cancer in this summary, we are referring to all 3.

This study was open for women to join between 2015 and 2017. The team published the results in 2019.

More about this trial

You may have surgery and chemotherapy to treat ovarian cancer that has spread. Cancer that has spread is advanced cancer. The chemotherapy you have usually includes the drugs carboplatin and paclitaxel. You may have them:

after surgery
before and after surgery

Researchers were looking for ways to improve treatment. In this study they looked at adding a drug called veliparib to chemotherapy. And continuing it after chemotherapy was finished. This continuation of treatment is called maintenance.

Veliparib is a type of targeted drug called a PARP inhibitor Open a glossary item . It blocks an enzyme that cancer cells need to repair themselves and grow. This enzyme is important for cells to repair their DNA . Particularly in cells that have a change (fault or mutation ) to the BRCA1 or BRCA2 genes.

In this study doctors hoped that if they could also stop PARP working, the cancer cells would not be able to repair themselves and would die.

Some women:

had carboplatin, paclitaxel and veliparib. And then continued to have veliparib on its own as maintenance.
had carboplatin, paclitaxel, and veliparib. And then a dummy drug (placebo ) as maintenance.
had carboplatin, paclitaxel and a dummy drug. And then a dummy drug as maintenance.

The main aims of this study were to find out:

if adding veliparib to carboplatin and paclitaxel and then continuing veliparib as maintenance treatment slowed cancer growth
more about the side effects

Summary of results

The team concluded that adding veliparib to chemotherapy and then continuing to have veliparib afterwards worked. It slowed cancer growth for women with advanced ovarian cancer.

About this study
1,140 women with high grade serous ovarian cancer took part in the study. It was a phase 3 study.

They were put into 1 of 3 groups at random:

382 women had veliparib with carboplatin and paclitaxel for 6 cycles . This was followed by daily veliparib treatment until the cancer got worse.
383 women had veliparib with carboplatin and paclitaxel for 6 cycles followed by a dummy drug
375 women had a dummy drug with carboplatin and paclitaxel for 6 cycles followed by a dummy drug (the control group )

Study randomisation diagram

Everyone had treatment for up to 2 years. Some women had surgery before they started the study or between the 3rd and 4th cycle of treatment.

Results
The team looked at how well treatment worked. To do this they grouped the women according to particular gene changes they had on their ovarian cancer cells. They put the women into 3 cohorts:

298 women had a fault in the BRCA1 or BRCA 2 genes (cohort 1)
627 women had a fault in the BRCA genes and/ or changes in genes called homologous recombination deficiency. This is expected to make cells act similar to if they had a fault in the BRCA genes (cohort 2)
everyone in the study (1,140 people) - this included both cohort 1 and 2 (cohort 3)

The team looked at how well treatment worked in women having chemotherapy and veliparib followed by maintenance veliparib. They compared this with women who had chemotherapy and the dummy drug followed by maintenance treatment with the dummy drug. This was the control group. Open a glossary item

The team followed everyone up for an average of 28 months. They looked at how long women lived before their cancer started to grow again. This is called progression free survival.

BRCA gene change (cohort 1)
In this cohort the team found the cancer started to grow again after about:

35 months in women who had the combination treatment followed by daily veliparib until the cancer got worse
22 months for women in the control group

Study results bar chart 1

HRD and/or BRCA gene change (cohort 2)
In this cohort the team found the cancer started to grow again after about:

32 months in women who had the combination treatment followed by veliparib maintenance
21 months for women in the control group

Study results bar chart 2

Everyone on the study (cohort 3)
In this cohort the team found the cancer started to grow again after about:

24 months in women who had the combination treatment followed by veliparib maintenance
17 months for the control group

Study results bar chart 3

Side effects
Women who had veliparib and chemotherapy and then veliparib continued as daily therapy had more problems with:

a drop in the number of red blood cells (anaemia )
a drop in the number of platelets
feeling sick
tiredness (fatigue)

These side effects improved when women stopped chemotherapy and were having veliparib on its own as maintenance treatment.

Quality of life
The team looked at how treatment affected quality of life. They found that quality of life improved when chemotherapy finished. Some of the side effects were worse in women who had veliparib. But they said that this didn’t seem to affect their quality of life. The team didn’t find much of a difference in quality of life between the 3 treatment groups.

Conclusion
The team concluded that having chemotherapy and veliparib and continuing to have veliparib afterwards improved treatment for advanced ovarian cancer.

It increased the length of time before the cancer started to grow again compared to the control group. But it’s unclear if adding veliparib to chemotherapy works without also having it as maintenance treatment.

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.