Extended Follow-Up Of A Real-World Cohort Of Patients (Pts) With Brca Mutation (Brcam) Relapsed Epithelial Ovarian Cancer (Eoc) Receiving Olaparib Maintenance Therapy: The Gineco Retrola Study

Olaparib was initially approved by the European Medicines Agency (EMA) as maintenance treatment for pts with BRCAm platinum-sensitive relapsed high-grade EOC, following the results of a randomized phase II trial (study 19). The RETROLA study aimed to evaluate whether the outcome observed in this clinical trial are reflected in routine clinical practice, in a real-world cohort of pts. We planned to include 130 pts in this retrospective cohort. French centers (n=28) representative of French regions and of mode of practice were asked to 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 (ptsEMA) by evaluating progression free survival (PFS) from olaparib initiation. 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 (n=22) and non high-grade serous EOC subtype (n=14). 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 ptsEMA 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 n=5 and n=1 pts. Number of previous lines of systemic therapy ≤2 was associated with prolonged PFS. With an extended follow-up, efficacy and toxicity of olaparib in real-world cohort of pts are consistent with findings observed in study 19 and SOLO-2 trials.