824P Real-world-data (RWD) on platinum (Pt) outcomes after PARP inhibitors (PARPi) progression in high grade serous ovarian cancer (HGSOC) patients (p)

Abstract

participate. Overall, 251 pts were identified. At each center, up to 6 pts who started olaparib (400 mg bid, capsule formulation) between 03/2014 and 03/2017 were randomly selected and included. Medical records were reviewed for clinic and pathologic characteristics, survival outcomes and safety. Our primary objective was to assess efficacy of olaparib in real-world pts treated upon initial EMA label (pts EMA ) by evaluating progression free survival (PFS) from olaparib initiation.Results: Overall, 128 pts were included in the analysis and 89 were treated according to EMA label. Main reasons to be given olaparib off-label were absence of radiological response following platinum-based chemotherapy (n¼22) and non high-grade serous EOC subtype (n¼14). BRCA1/2 mutation was present in 126 pts (98%). Most pts (68%) received olaparib after 3 or more lines of platinum-based chemotherapy. Median follow up was 41.8 months. Median PFS in pts EMA was 17.0 months (95% CI: 14.7-21.3). Median PFS and overall survival (OS) in the whole population were 15.5 months (95% CI: 12.6-18.1) and 33.6 months (95% CI: 28.7; 40.3), respectively. Fourteen (11.2%) pts stopped olaparib for toxicity reason and 75 (58.6%) had at least one dose reduction or one dose interruption. Related myelodysplastic syndrome and second cancers were diagnosed in respectively n¼5 and n¼1 pts. Number of previous lines of systemic therapy 2 was associated with prolonged PFS.Conclusions: With an extended follow-up, efficacy and toxicity of olaparib in realworld cohort of pts are consistent with findings observed in study 19 and SOLO-2 trials.Clinical trial identification: NCT04152941.Legal entity responsible for the study: ARCAGY-GINECO.