3353 - Results of the 3rd interim analysis of C-Patrol: A non-interventional study on olaparib in German routine clinical practice

Background

Olaparib (50 mg hard capsules, HC) was the 1^st PARPi approved in the EU in 12/2014 as monotherapy for maintenance treatment of adult patients with platinum-sensitive relapsed BRCA-mutated (BRCAm) ovarian cancer (PSR-OC) who are in response to platinum-based chemotherapy. In addition, film-coated tablets (FT, 100/150 mg) were approved in 05/2018 regardless of BRCA status. Here, we report for the first time data on real-world olaparib treatment from patients who switched from HC to FT.

Methods

The German prospective non-interventional study C-PATROL (NCT02503436) collects routine clinical and patient-reported outcome data in BRCAm PSR-OC patients treated according to label with olaparib with the recommended total daily dose of 800 mg (HC) or 600 mg (FT). The 3^rd interim analysis (cut-off: 01APR2019) for patients treated with olaparib (HC/FT) reflects data on patient characteristics and safety by using descriptive statistics focussing on “switcher” (here patients can be treated with FT since 08/2018).

Results

252 olaparib-treated patients were analysed; 177 (70.2%) were treated with HC, 47 (18.7%) switched from HC to FT, and 28 (11.1%) were newly initiated with FT. Median therapy durations for the three subgroups were 9.0 months (HC), 17.4 months (switcher; 13.4 months before [HC] and 4.4 months after [FT] switch) and 9.2 months (FT). 44 switcher (93.6%) had adverse events (AEs); 41 (87.2%) before and 26 (55.3%) after switching. Treatment modifications due to AEs were more frequent prior to switching (i.e. during HC treatment). In total, 30 switcher had therapy modifications; 25 (83.3%) before and 11 (36.7%) after switching.

Conclusions

The 3^rd interim analysis indicates that under routine conditions, olaparib is well tolerated in patients who switched from HC to FT. In fact, fewer AEs occurred after switching. The toxicity profile observed so far is in line with the results of the clinical trial program for olaparib in PSR-OC and 1^st-line maintenance. Funding: AstraZeneca.

Clinical trial identification

NCT02503436.

Editorial acknowledgement

Yvonne Holighaus, Alcedis GmbH, Gießen, Germany, funded by AstraZeneca.

Legal entity responsible for the study

AstraZeneca Germany.

Funding

AstraZeneca Germany.

Disclosure

J. Sehouli: Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: PharmaMar; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Clovis; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Tesaro; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Roche; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: AstraZeneca; Advisory / Consultancy: Roche Diagnostics; Advisory / Consultancy: Merck; Advisory / Consultancy: Bayer; Advisory / Consultancy: Eisai; Advisory / Consultancy: Johnson&Johnson; Advisory / Consultancy: MSD; Advisory / Consultancy: Novocure; Advisory / Consultancy: Amgen; Advisory / Consultancy, Research grant / Funding (institution): Lilly; Research grant / Funding (institution): Medimmune; Research grant / Funding (institution): Bristol-Myers. F. Hilpert: Honoraria (self), Advisory / Consultancy: AstraZeneca; Honoraria (self), Advisory / Consultancy: Clovis; Honoraria (self), Advisory / Consultancy: Roche; Honoraria (self), Advisory / Consultancy: Tesaro; Advisory / Consultancy: MDS; Honoraria (self), Advisory / Consultancy: PharmaMar; Honoraria (self): Pfizer; Honoraria (self), Advisory / Consultancy: Novartis. J.P. Grabowski: Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: AstraZeneca; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Tesaro; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony: Clovis; Honoraria (self): Roche; Honoraria (self): Pfizer; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Riemser 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: Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony: AstraZeneca; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony: Eisai; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony: GenomicHealth; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony: MSD; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony: Novartis; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony: Pfizer; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony: Roche; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony: Tesaro; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony: Teva; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony: Lilly. R. Glowik: Full / Part-time employment: AstraZeneca. F. Marmé: Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: AstraZeneca; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Tesaro; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Roche; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Novartis; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Pfizer; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: PharmaMar; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: GenomicHealth; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: CureVac; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Amgen; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Eisai; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: MSD; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Celgene; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Clovis. All other authors have declared no conflicts of interest. Linguistic correction