EXPLORER
Research type
Research Study
Full title
Experience of Rucaparib as maintenance treatment following platinum based chemotherapy in relapsed ovarian cancer - a UK real world study
IRAS ID
293749
Contact name
Ros Glasspool
Contact email
Sponsor organisation
NHS Greater Glasgow & Clyde
ISRCTN Number
ISCRTN10125751
Duration of Study in the UK
4 years, 0 months, 2 days
Research summary
Research Summary
Rucaparib is an oral PARP inhibitor. PARP is a protein which helps cells repair their DNA. PARP inhibitors stop the PARP from doing this repair work Cancers cells are the main target as they often already have problems with their ability to repair DNA damage and inhibiting PARP can result in the cells dying.
A clinical trial in women with recurrent ovarian cancer showed that by taking Rucaparib after a course of chemotherapy, the cancer could be controlled for longer before it started to grow again. However there are side effects with Rucaparib. The people who enter clinical trials are a selected group, who are often younger and have few other medical conditions. We think that the side effects and outcomes of rucaparib treatment may be different in the wider population treated in every day practice. In this project we are investigating the frequency and severity of the side effects of Rucaparib and how often women need to have breaks in treatment or a dose reduction due to the side effects in every day practice. We would also like to learn more about how the treatment affects everyday life, expectations of treatment, fears they have about their cancer, the outcomes of treatment and how women feel about their decision to have maintenance treatment. We are also collecting blood samples to allow investigation of why Rucaparib works better for some people than others.Summary of Results
In a previous clinical trial (ARIEL3), rucaparib was shown to delay the time until the cancer came back or started to grow again in women with recurrent high-grade ovarian cancer who had been treated with platinum type chemotherapy and where the cancer had got smaller on chemotherapy. As a result it became available as a standard treatment in the NHS. However, women on the trial experienced quite a few side effects and many needed to have breaks in treatment or the dose reduced. Clinical trials of new drugs have strict criteria for entering the study which means that the people who enter a trial are often younger and have few other medical conditions. So, it is important to see whether similar results are found when drugs are used in every day practice in a population who may be older and have more medical conditions. This trial aimed to see if the side effects from rucaparib and number of dose reductions or interruptions were different in real-world population. It planned to look at how long the cancer was kept under control on treatment and how long people lived for. It also aimed to look at the impact of treatment on overall quality of life, how easy it was for people on treatment to carry on fulfilling their everyday roles like working and caring and how much people were affected by fear of their cancer getting worse or coming back again. Blood samples were also collected for translational research.
The study aimed to recruit 100 people but unfortunately the study had to end early because the company that was providing the grant filed for bankruptcy, so there was no further funding to continue. 34 women were included and 32 started treatment. The median time that women were on treatment was 3.5 cycles. 79% experienced at least one side effect and these were severe in 28%. 34% needed an interruption in their treatment (median 21 days), 6% required a dose reduction and 5 stopped treatment due to side effects. Though this study followed people for a shorter time than the ARIEL 3 trial the side effects did not appear to be worse in this real-world population. The trial closed before it was possible to get an indication of how long cancers were controlled for or how long women lived. There was no change in the median scores for quality of life or roles and responsibilities between before treatment and after 2 cycles but when the proportions of individuals with a change in their scores on separate aspects of quality of life (sub-scales) was looked, some had improvement and some had worsening. For example 9 patients (50%) had a significant reduction in role functioning and 7 (41%) a reduction in global quality of life. Overall the fear of progression fell whilst on treatment but 24% of women had very high levels. Levels this high are known to impact on women’s well-being and quality of life.
REC name
West of Scotland REC 4
REC reference
21/WS/0032
Date of REC Opinion
10 Mar 2021
REC opinion
Favourable Opinion