Olaparib First-Line Maintenance Monotherapy in BRCA-Mutated Epithelial Ovarian Cancer: Descriptive Analysis of the First French Real-World Data Study

• DOI: 10.1007/s40801-022-00349-9
• Publication Date: 2023-01-11T07:02:43Z
• Authors: Charlotte Bellier; Laurence Gladieff; Fanny Le Du; Dominique Berton; Charlotte Bonnard; Delphine Suau; Anne-Céline Richard; Ophélie Brenner; Amir Lahouegue; Gilles Freyer; Anne Floquet; Sophie Frank; Maria Kfoury
• Keywords: Olaparib; BRCA Mutation

Olaparib, a poly(ADP-ribose) polymerase inhibitor, was approved by the European Commission in June 2019, following results of SOLO-1/GOG 3004 trial as maintenance monotherapy adult patients with BRCA-mutated epithelial ovarian cancer. This study aimed to provide descriptive analysis first real-world data from cancer who received olaparib first-line French cohort Temporary Authorisation for Use (Autorisation Temporaire d'Utilisation de cohorte, ATUc) programme 11 March, 2019 16 January, 2020. Eligible were aged 18 years and over confirmed ovarian, primary peritoneal or Fallopian tube deleterious suspected germline somatic BRCA 1/2 mutation. Patients complete partial clinical response at end platinum-based chemotherapy. Olaparib therapy initiated within 8 weeks patients' last dose Real-world collected through treatment access request forms completed physicians. Clinical safety monthly until ATUc programme. A total 107 centres metropolitan France Overseas Departments Territories requested inclusion 238 patients, whom 194 olaparib. In total, 87.6% tumour locations ovary, most common histology high-grade serous (93.0%) International Federation Gynaecology Obstetrics (Fédération Internationale Gynécologie et d'Obstétrique) stage IIIC (56.8%). testing performed routine practice, prior into All had mutation: 52.5% mutation, 38.4% germinal mutation 9.1% mutations. Twenty-four (12%) experienced serious adverse drug reactions follow-up (17 February, 2020). The anaemia (12 [6%] patients), neutropenia (3 [2%] patients) thrombocytopenia patients). rapid enrolment highlighted strong unmet need treatment. well tolerated no new signals observed this patient population.