Olaparib routine clinical practice in Germany – Quality of life interim results of the non-interventional C-PATROL study

Aim Olaparib (50 mg hard capsules) was the first PARP inhibitor approved in the EU in 12/2014 as monotherapy for maintenance treatment of adult patients with platinum-sensitive relapsed BRCA-mutated ovarian cancer (PSR-OC) who are in response to platinum-based chemotherapy. Since May 2018, a line extension is available in the EU for olaparib film-coated tablets (100 mg/150 mg) regardless of BRCA status. Preservation of health-related quality of life (HRQoL) is important during olaparib maintenance. So far, only limited data on real-world olaparib treatment are available.

Methods The German prospective, non-interventional study C-PATROL collects real-world clinical and patient-reported data for treatment with olaparib according to label. In total, 278 patients were enrolled in the study until 30/09/2019 (end of recruitment). The 4^th interim analysis will focus on HRQoL data (planned data cut-off: 04/2020).

Results HRQoL in PSR-OC under olaparib maintenance is evaluated by patient-reported outcomes (PROs). QoL is assessed by FACT-O (Functional Assessment of Cancer Therapy-Ovarian Cancer), fatigue symptoms by FACIT (Functional Assessment of Chronic Illness Therapy)-Fatigue, and the impact of chemotherapy-induced nausea and vomiting on the patients’ daily life by FLIE (Functional Living Index Emesis). HRQoL is assessed at each visit, which is according to the current treatment guidelines recommended at three-monthly intervals.

Summary This interim analysis provides the first real-world data on patient-reported HRQoL in PSR-OC patients receiving olaparib maintenance in Germany.

Funding AstraZeneca

Interessenkonflikt

Ahmed El-Balat: membership on advisory councils, speaker’s activities for AstraZeneca, Roche, PharmaMar, Olympus Frederik Marmé:Honoraria: Roche/Genentech, Novartis, Pfizer, AstraZeneca, Tesaro, Clovis Oncology, Eisai, Celgene, Genomic Health, PharmaMar, Amgen, CureVac, MSD Oncology, Janssen-Ciliag, Immunomedics (institutions); Consulting or Advisory Role: Tesaro, Pfizer, Novartis, GenomicHealth, CureVac, Amgen, Celgene, Eisai, Janssen-Cilag, AstraZeneca (institution), Roche (institution), Vaccibody (institution), Immunomedics (institution), Research Funding: Roche/Genentech (institution), Novartis (institution), AstraZeneca (institution), Eisai (institution), Tesaro (institution), Clovis Oncology (institution), MSD Oncology (institution), Vaccibody (institution), Travel, Accommodations, Expenses: Roche, Pfizer, Novartis, PharmaMar, AstraZeneca, Jalid Sehouli: Advisory and expert activities for PharmaMar, Clovis, Tesaro, Roche, Roche Diagnostics, Astra Zeneca, Merck, Bayer, Eisei, Johnson and Johnson, MSD, Novocure, Amgen, Lilly; Receipt of professional fees from PharmaMar, Clovis, Tesaro, Roche,Astra Zeneca, Receipt of research grant support (institution) from PharmaMar, Clovis, Tesaro, Roche, Astra Zeneca, Medimmune, Bristol Myers, Lilly. Travel/Accommodation/Expenses: PharmaMar, Clovis, Tesaro, Roche, Astra Zeneca, Manfred Welslau: No conflict of interest, Jacek Grabowski: Advisory, consultancy and speakers activities for AstraZeneca, GSK-Tesaro, Clovis, Riemser, Roche, Pfizer, Vifor Pharma; Honoraria from AstraZeneca, Tesaro, Roche, Clovis, Pfizer, Riemser; Travel/Accommodation from AstraZeneca, Tesaro, Riemser, Andreas Hartkopf has received honoraria (speakers bureau and consulting fees) from AstraZeneca, Eisai, GenomicHealth, Lilly, MSD, Novartis, Pfizer, Roche, Tesaro, Teva. Regina Glowik: full-time employment AstraZeneca, Felix Hilpert: membership on advisory boards for AstraZeneca, Roche, Tesaro, Clovis, MSD, PharmaMar, receipt of honoraria from Astra Zeneca, Clovis, Roche, Tesaro MSD, PharmaMar, Pfizer, Novartis

Publication History

Article published online:
07 October 2020