Abstract 1677
Background
The efficacy and tolerability of front-line BEV combined with carboplatin–paclitaxel (CP) for OC has been demonstrated in randomised phase III trials. To assess the safety and effectiveness of front-line BEV-containing therapy in the real-world setting in Germany, we initiated the single-arm non-interventional OTILIA study. The latter part of OTILIA focused on elderly pts. We report the second interim analysis.
Methods
Pts with FIGO stage IIIB–IV OC received front-line BEV + CP according to the EU label. Adverse events were recorded at each cycle and graded using CTCAE v4.0. Investigators assessed response according to local practice. Exploratory analyses compared safety and efficacy according to age.
Results
Between Feb 2012 and Jan 2016, 713 pts from 200 centres received BEV-containing treatment per the EU label. More pts aged
Conclusions
Exploratory analyses of OTILIA showed no evidence that age is associated with worse outcome (preliminary efficacy or tolerability) in pts receiving BEV for primary OC. BEV is an active and tolerable front-line treatment option that should be considered irrespective of age.
Clinical trial identification
NCT01697488
Legal entity responsible for the study
Roche Pharma AG, Germany
Funding
Roche Pharma AG, Germany
Disclosure
A. Mustea, R. Richter: Membership of Advisory Board: Roche. P. Wimberger: Member of Advisory Board: Roche, Novartis, Amgen, MSD, AstraZeneca, Teva, PharmaMar, Fresenius Biotech; Corporate-sponsored research: Roche, Novartis, Amgen, Fresenius Biotech, MSD. J. Harde, S. Klawitter, A. Wegenaer: Employee: Roche Pharma AG. J. Sehouli: Member of Advisory Board: Roche, AstraZeneca. All other authors have declared no conflicts of interest.