Abstract 825P
Background
The preservation of health-related quality of life (HRQoL) is a very important treatment goal in relapsed ovarian cancer (OC) patients during maintenance treatment. Olaparib hard capsules were the first poly (ADP-ribose) polymerase inhibitor approved in the EU in Dec 2014 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 4th interim analysis (cut-off date: 22/04/20), HRQoL was evaluated during the 1st 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 ± SD at baseline: 111.1 ± 19.2 and 71.8 ± 13.6, and at month 12: 109.8 ± 22.1 and 71.2 ± 15.6); fatigue (FACIT-F) also remained stable (mean score ± SD at baseline: 34.7 ± 10.9, and at month 12: 33.9 ± 12.5).
Conclusions
This analysis indicates that maintenance treatment with olaparib is well tolerated under routine conditions and had no apparent adverse impact on HRQoL. Results are in line with HRQoL results of the clinical trial program for olaparib in PSR-OC.
Clinical trial identification
NCT02503436.
Editorial acknowledgement
Medical writing assistance was provided by Dr. Yvonne Holighaus, Alcedis GmbH, Giessen, funded by AstraZeneca.
Legal entity responsible for the study
AstraZeneca, Germany.
Funding
AstraZeneca, Germany.
Disclosure
F. Marmé: Honoraria (institution), Research grant/Funding (institution): Roche/Genentech; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Novartis; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Pfizer; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: AstraZeneca; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Tesaro; Honoraria (self), Research grant/Funding (institution): Clovis Oncology; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Eisai; Honoraria (self), Advisory/Consultancy: Celgene; Honoraria (self), Advisory/Consultancy: Genomic Health; Honoraria (self): PharmaMar; Advisory/Consultancy, Travel/Accommodation/Expenses: Roche; Honoraria (self), Research grant/Funding (institution): MSD Oncology; Advisory/Consultancy, Research grant/Funding (institution): Vaccibody; Honoraria (institution), Advisory/Consultancy: Immunomedics; Honoraria (self), Advisory/Consultancy: CureVac; Honoraria (self), Advisory/Consultancy: Amgen; Honoraria (self), Advisory/Consultancy: Janssen-Cilag. F. Hilpert: Honoraria (self), Advisory/Consultancy: AstraZeneca; Honoraria (self), Advisory/Consultancy: Roche; Honoraria (self), Advisory/Consultancy: Tesaro; Honoraria (self), Advisory/Consultancy: Clovis; Honoraria (self), Advisory/Consultancy: MSD; Honoraria (self), Advisory/Consultancy: PharmaMar; Honoraria (self): Pfizer; Honoraria (self): Novartis. J.P. Grabowski: Honoraria (institution), Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: AstraZeneca; Honoraria (institution), Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: GSK-Tesaro; Honoraria (institution), Advisory/Consultancy, Speaker Bureau/Expert testimony: Clovis; Honoraria (institution), Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Riemser; Honoraria (institution), Advisory/Consultancy, Speaker Bureau/Expert testimony: Roche; Honoraria (institution), Advisory/Consultancy, Speaker Bureau/Expert testimony: Pfizer; Advisory/Consultancy, Speaker Bureau/Expert testimony: Vifor Pharma. A. El-Balat: Advisory/Consultancy, Speaker Bureau/Expert testimony: AstraZeneca; Advisory/Consultancy, Speaker Bureau/Expert testimony: Roche; Advisory/Consultancy, Speaker Bureau/Expert testimony: PharmaMar; Advisory/Consultancy, Speaker Bureau/Expert testimony: Olympus. A. Hartkopf: Advisory/Consultancy, Speaker Bureau/Expert testimony: AstraZeneca; Advisory/Consultancy, Speaker Bureau/Expert testimony: Eisai; Advisory/Consultancy, Speaker Bureau/Expert testimony: GenomicHealth; Advisory/Consultancy, Speaker Bureau/Expert testimony: Lilly; Advisory/Consultancy, Speaker Bureau/Expert testimony: MSD; Advisory/Consultancy, Speaker Bureau/Expert testimony: Novartis; Advisory/Consultancy, Speaker Bureau/Expert testimony: Pfizer; Advisory/Consultancy, Speaker Bureau/Expert testimony: Roche; Advisory/Consultancy, Speaker Bureau/Expert testimony: Tesaro; Advisory/Consultancy, Speaker Bureau/Expert testimony: Teva. R. Glowik: Full/Part-time employment: AstraZeneca. J. Sehouli: Honoraria (institution), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: PharmaMar; Honoraria (institution), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Clovis; Honoraria (institution), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Tesaro; Honoraria (institution), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Roche; Advisory/Consultancy: Roche Diagnostics; Honoraria (institution), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: AstraZeneca; Advisory/Consultancy: Merck; Advisory/Consultancy: Bayer; Advisory/Consultancy: Eisai; Research grant/Funding (institution): Bristol-Myers; Advisory/Consultancy, Research grant/Funding (institution): Lilly; Research grant/Funding (institution): MedImmune; Advisory/Consultancy: Johnson and Johnson; Advisory/Consultancy: MSD; Advisory/Consultancy: Novocure; Advisory/Consultancy: Amgen. All other authors have declared no conflicts of interest.