ODALIE Study, a retrospective analysis of a real-life cohort of patients with de novo advanced high grade epithelial ovarian cancer treated with a first-line platinum- and taxane-based chemotherapy combined with bevacizumab.

e17577 Background: PARP inhibitors (PARPi) demonstrated improvement in progression-free survival (PFS) following a first line platinum-based chemotherapy including bevacizumab for HRD-positive advanced ovarian carcinoma (OC) patients (pts) (PAOLA-1 study). We aimed to describe real-world (rw) clinical outcomes in patients with de novo high grade epithelial advanced ovarian cancer (HGEOC) treated with a first-line platinum- and taxane-based chemotherapy combined with bevacizumab. Methods: Using the Epidemiological Strategy and Medical Economics (ESME) Ovarian Cancer (OC) Data Platform [NCT03275298], a French EHR-derived database centralizing deidentified data of consecutive patients diagnosed and/or treated in 18 French comprehensive cancer centers since 2011, we identified all patients with de novo FIGO stage III/IV HGEOC diagnosed between 01 October 2012 and 31 January 2017, with a documented response to a first-line platinum-based chemotherapy and a maintenance treatment with bevacizumab ( PAOLA-like control group population). Data cut-off was 06 August 2020. Endpoints (overall survival, PFS and time to subsequent treatment) were estimated using the Kaplan-Meier method. Subgroups were analysed according to the BRCA-derived status. Results: Of 10,263 OC cases in the ESME-OC cohort, 382 patients, with a median follow-up of 47.8 months (CI 95% 44.4-49.1), were analysed. Median age was 61 years (q1-q3: 56-68). 290 pts (75.9%) had a FIGO stage III, 361 pts (94.5%) had at least one surgery, 141 (39.1%) and 210 (58.5%) of them had a primary cytoreductive surgery and an interval surgery respectively. BRCA deleterious mutations were present in 72 pts (22.3%). Median progression free survival was 23.2 months (CI 95% 20.9-24.8) in overall population and 25.3 months (CI 95% 19.7-23.8) in BRCA mutated pts, comparable to the control arm of PAOLA-1 when considering the difference in the PFS definition (from first CT versus from randomization in PAOLA study). Estimated 24-months overall survival rate was 45.7% (95% CI: 40.7- 50.7) and 53.9% (95% CI: 42.4 - 65.5) in BRCA mutated pts. Conclusions: Analyses of our large real-world French ESME-OC cohort are powerful tools to confirm clinical outcomes in HGEOC pts. Our data confirmed the reproducibility of the results observed in randomized clinical trials for de novo HGEOC pts with a documented response to a first line with bevacizumab maintenance therapy.