Introduction/Background*Standard therapy for advanced ovarian cancer (OC) includes radical debulking surgery followed by first-line platinum-based chemotherapy, although neo-adjuvant chemotherapy can be used. Most women with newly diagnosed advanced OC relapse within 3 years of standard treatment.
In SOLO1, patients with advanced OC and a BRCA1 and/or BRCA2 mutation (BRCAm), in complete or partial response following first-line platinum-based chemotherapy, received maintenance olaparib or placebo for up to 2 years or until progression. At 5-year follow-up, median progression-free survival (PFS) was 56 months with olaparib vs 14 months with placebo (hazard ratio 0.33; 95% confidence interval 0.25–0.43). The OVAL-1 study will provide evidence on real-world effectiveness of olaparib in patients with BRCAm advanced OC treated in the first-line maintenance setting in France, Italy and the UK.
Methodology Retrospective cohort, pan-European multicentre observational study with data abstracted from medical records at several time points until ≥3 years after first olaparib dose (index date).
Eligible patients are adult females with a BRCAm and advanced (FIGO stage III/IV) OC, who received their first olaparib (tablet) dose between January 2019 and June 2020 in the first-line maintenance setting via Early Access Programmes (Italy, UK), Temporary Use Authorization (France) or reimbursement following regulatory approval (Italy, UK). Main study endpoint is real-world PFS. Secondary endpoints include overall survival and response rates. The study will also describe surrogate measures of response and tolerability, including time to discontinuation, dose modifications (with reasons) and time to first and second subsequent treatment. Outcomes will be described by key subgroup status pre-index, including performance status, FIGO stage, BRCAm status, debulking surgery outcome and clinical response to chemotherapy. The study aims to include 350 patients. Retrospective data collection began in December 2020 and is planned to end by Q3 2023. As of April 2021, 69 patients have participated.
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