Using interim data from the single-arm non-interventional OTILIA study (NCT01697488; NOGGO) of front-line BEV + CT for OC in routine practice, we explored the impact of pre-existing comorbidities on clinical outcome.
Pts with FIGO stage IIIB–IV OC received front-line BEV + CT according to the EU label. Adverse events (AEs; CTCAE v4.0) were recorded at each cycle. Post hoc analyses explored safety and effectiveness in subgroups of pts with diabetes mellitus, ongoing hypertension (HTN) or cardiovascular (CV) comorbidities (coronary heart disease, heart failure, arrhythmia, ongoing HTN, thromboembolic event).
As of 31 Jan 2017, data were available for 808 of 1190 planned pts. Comorbidities were more common in pts aged ≥70 (n = 382) than
In OTILIA, pts with comorbidities had similar PFS to the overall population, despite older age and worse ECOG PS. Grade 3/4 AEs were slightly more common, particularly in pts with diabetes mellitus, but did not lead to treatment discontinuation. These post hoc analyses suggest that with appropriate care, BEV is an option in pts with comorbidities.
Clinical trial identification
Legal entity responsible for the study
Roche Pharma AG
Roche Pharma AG
H. Woopen: Membership on advisory board or board of directors: Roche Pharma AG. P. Wimberger: Membership on advisory board or board of directors: Roche, Novartis, Amgen, AstraZeneca, MSD, TEVA, Pharma Mar, Fresenius Biotech; Corporate-sponsored research: Roche, Novartis, Amgen, Fresenius Biotech, MSD. A. Mustea: Membership on advisory board or board of directors: Roche. S. Klawitter, A. Wegenaer: Employment: Roche Pharma AG. J. Sehouli: Membership on advisory board or board of directors: AstraZeneca, Roche, OBI Pharma, Pfizer, Clovis, NovoCure. All other authors have declared no conflicts of interest.