Ovarian Cancer, Quality of Life
Conditions
Keywords
PARPi, HRD testing
Brief summary
Patients with ovarian cancer with defective DNA repair mechanisms derive substantial benefit from PARP inhibitor (PARPi) maintenance therapy. Both niraparib and olaparib are effective inhibitors of PARP, which exploit already defective DNA repair mechanisms (e.g., via BRCA mutations), particularly those with homologous recombination deficiency (HRD). These two PARPis have notably different toxicity profiles, with niraparib showing many more severe side effects. In this Ovarian Cancer Canada funded study, we will implement perform HRD testing for ovarian cancer patients in Saskatchewan with response to platinum-based chemotherapy. This information will provide personalized and precision estimates about the amount of benefit that can be expected from taking a PARPi. We will evaluate both treatment outcomes and quality of life in a real-world study setting, to inform future decision-making regarding efficacy, quality of life and cost-effectiveness of PARPi therapy, specifically for niraparib. We hypothesize that for patients who are homologous recombinant proficient (HRP), the median 32.7-month incremental benefit (in delaying cancer progression) from taking a PARPi (niraparib is the only PARPi approved in this setting) will not be seen as being value-add when balanced by the decreased quality of life that accompanies the first 6-12 weeks of therapy. We also hypothesize that for women who are HRP, that PARPi therapy will not be cost-efficient.
Interventions
OTHERPatients that are HRP are given a decision aid for PARPi use
Study created patient decision aid if the first for HRD tested Ovarian Cancer patients
Sponsors
University of Saskatchewan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
This is a pragmatic trial which offers HRD testing and for patients HRProficient, a patient decision aid to help them decide whether niraparib is right for them. Whatever they decide, we followup with QoL questionnaires and assessment of time to progression.
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* Known or suspected stage 3/4 high grade serous or endometrioid ovarian cancer Able to provide oral consent and complete questionnaires in English as per study protocol
Exclusion criteria
* Ineligible for Maintenace PARPi therapy Refusal to undergo HRD testing
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient decision for use of PARPi therapy | 6 Monhs | The proportion of HRP patients who choose to undergo PARP therapy. |
Countries
Canada
Outcome results
None listed