827P First real-life data on olaparib in 1st line (1stL) maintenance BRCA1/2 mutated epithelial ovarian cancer (EOC) in France: Descriptive analysis of 201 patients (pts) enrolled in the cohort temporary authorization for use (ATUc)

Abstract

as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed (PSR) BRCA-mutated OC who are in response to platinum-based chemotherapy (PBC). In addition, film-coated tablets were approved in the EU in May 2018 for PSR-OC regardless of BRCA status, and in June 2019 for adult patients with advanced BRCA-mutated OC who are in response to first-line PBC. So far, only limited data on real-world maintenance monotherapy with olaparib are available. We evaluated HRQoL during olaparib maintenance in this observational study. Methods:The German prospective non-interventional study C-PATROL (NCT02503436) collects routine clinical and patient-reported outcome (PRO) data of BRCA-mutated PSR OC patients treated with olaparib according to label. In total, 278 patients were enrolled in the study until 30 Sep 2019 (end of recruitment). In the 4 th interim analysis (cut-off date: 22/04/20), HRQoL was evaluated during the 1 st year of olaparib maintenance therapy using the FACT-Ovarian and FACIT-Fatigue questionnaires.Results: 271 BRCAm PSR OC patients treated with olaparib were analyzed (median age: 60 yrs; ECOG 1: 93%; !2 relapses: 32%; !3 prior platinum chemotherapies: 34%). More than 80% have provided questionnaires at baseline and month 3; and >60%, 55% and 45% at month 6, 9 and 12, respectively, until data cut-off. The FACT-O total score as well as trial outcome index (TOI) remained consistent over time (mean scores

Real-World Data on Olaparib in Relapsed BRCA-mutated Ovarian Cancer: A Multicenter GINECO RETROLA Cohort Study

“…The separate standalone safety and efficacy findings from the China cohort of SOLO2 (consisting of 32 randomized patients from sites in China) (25) showed similar results. (26). In this study, olaparib was well tolerated and no new safety signals were observed in this setting.…”

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

“…From 11 March, 2019 to 16 January, 2020, 107 centres requested inclusion for 238 patients; 201 requests were accepted, 28 were denied because they did not meet the ATUc criteria and 9 requests were awaiting additional information on 16 January, 2020, and were ultimately deemed as not acceptable for inclusion in the ATUc. The main reason for the ATUc exclusion was that the time between the last chemotherapy cycle and the request was greater than 8 weeks (Table 1) [15]. A total of 194 patients received olaparib maintenance therapy.…”

“…National coverage is shown in Fig. 1 [15]. Five requests (3.0%) were made by physicians from the French Overseas Departments and Territories: Guadeloupe and Ile de la Réunion.…”

“…BRCA testing was performed in routine practice, prior to the ATUc inclusion, and 38.4% of patients had a germline BRCA mutation, 52.5% had a somatic BRCA mutation and 9.1% had germline and somatic BRCA mutations. After platinum-based chemotherapy, 83.8% of patients had a complete clinical response and 16.2% had a partial response (Table 2) [15].…”

“…Adverse drug reactions of any grade occurred in 70 patients. Serious ADRs occurred in 24 patients (Table 3) [15]. The most common reported serious ADRs with olaparib were anaemia (n = 12), neutropenia (n = 3) and thrombocytopenia (n = 3).…”