A Study to Characterize the Outcomes of Olaparib Maintenance Monotherapy in Newly Diagnosed BRCAwt Ovarian Cancer

Study Overview
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Brief Summary
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This study will collect the data from existing patient medical records at US cancer centers. The study will include patients with BRCAwt ovarian cancer who have been prescribed first line (1L) olaparib maintenance treatment.

Detailed Description
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This is a United States (US) based multicenter, retrospective, observational cohort study with data abstracted from patient medical records. In this observational study, it is planned to include approximately 150 US female patients with newly diagnosed advanced ovarian cancer (AOC) who were tumor biomarker tested between first diagnosis with AOC and first prescription of 1L olaparib maintenance monotherapy as tumor breast cancer gene wild type (BRCAwt) with a known homologous recombination deficiency (HRD) status. This retrospective cohort study will include patients with first olaparib prescription between Jan 2017 and Dec 2021. All data collection will be retrospective. Data will be collected from the date of first olaparib prescription (index date) with a follow-up period of at least 18 months post index date.

Official Title
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FLAME - First Line olAparib Maintenance bEyond BRCA An Observational Cohort Study to Characterize the Outcomes of Olaparib Maintenance Monotherapy Beyond BRCA Mutant Status in Newly Diagnosed Advanced Ovarian Cancer

Conditions
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Advanced Ovarian Cancer

Intervention / Treatment
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* Other: None (Observational Study)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female adult, age ≥ 18 years BRCAwt AOC diagnosed with any approved BRCA test Has documented HRD status based on available test results Received 1L olaparib maintenance monotherapy following platinum chemotherapy Patients must have been treated with platinum-based chemotherapy at first-line Exclusion Criteria: Received another poly adenosine diphosphate ribose polymerase (PARP) inhibitor or bevacizumab before or while prescribed olaparib Participation in an interventional clinical study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 130 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Retrospective Cohort<br>Patients with newly diagnosed AOC BRCAwt with known HRD status who have been prescribed 1L olaparib maintenance treatment. | Other: None (Observational Study)<br>* Not Applicable since observational study<br>* Other names: Observational Study;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical and Demographics characteristics | Clinical and Demographic characteristics including disease/FIGO stage, histology and tumor grade at initial Ovarian Cancer diagnosis, cancer antigen 125 (CA-125) level, Eastern Cooperative Oncology Group (ECOG) or other performance status, number and type of chemotherapy cycles, cytoreductive/debulking surgery type and outcomes, and selected comorbidities at index date will be described. Summary statistics will be used to describe the Demographics and clinical characteristics. The outcome will be measured for HRD+ patients. | At Index date - first olaparib prescription (Jan 2017 to Dec 2021) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Real-world time to first subsequent treatment or death (rwTFST) | rwTFST is defined as the time from the index date (date of the first olaparib prescription) to the earliest of the date of death or commencement of first subsequent anticancer treatment. The outcome will be measured for HRD+ patients. | Jan 2017 to Jun 2023 | 
| Real-world time to treatment discontinuation or death (rwTTD) | rwTTD is defined as the time from the index date to the earliest of the date of death or discontinuation of olaparib. The outcome will be measured for HRD+ patients. | Jan 2017 to Jun 2023 | 
| Number of patients with clinical event of interest (CEI) | To summarize the real-world safety and tolerability profile based on pre-specified CEIs of 1L olaparib maintenance monotherapy in BRCAwt newly diagnosed AOC patients regardless of HRD status. | Jan 2017 to Jun 2023 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Real-world evidence, Homologous recombination deficiency, breast cancer gene, breast cancer gene mutated, breast cancer gene wild type