The GOG-0218 and ICON7 randomised phase III trials demonstrated the efficacy and safety of front-line BEV + CT for OC. The single-arm OTILIA study is evaluating BEV + CT in German clinical practice. In a previously reported interim analysis (ESMO & IGCS 2016), the observed safety and effectiveness were consistent with phase III results (preliminary median progression-free survival [PFS] 21.7 months). To address the lack of data on the impact of BMI on safety and clinical outcome in pts receiving CT + BEV, we performed exploratory analyses of the OTILIA dataset.
In OTILIA (NCT01697488), pts with FIGO stage IIIB–IV OC received front-line BEV + CT according to the EU label. Adverse events (CTCAE v4.0) were recorded at each cycle. Investigators assessed response per local practice. We performed post hoc exploratory subgroup analyses of the third interim dataset according to BMI and a multiple Cox regression analysis of PFS vs BMI, age, ECOG performance status, FIGO stage, residual disease and ascites as covariates.
BMI was available for 785 of 808 pts. Treatment duration was similar across BMI subgroups (Table). There were no significant differences in PFS between subgroups with BMI ≤20 (hazard ratio [HR] 1.27; 95% CI 0.92–1.77) or ≥ 30 (HR 1.33; 95% CI 0.98–1.81) vs > 20–25 kg/m2 (Cox regression model) but in pts with a BMI ≤20 kg/m2, numerically more grade 3/4 and serious adverse events were observed.Table:
|Parameter, n (%)||BMI, kg/m2|
|≤20 (n = 107)||>20–25 (n = 329)||>25–|
In these post hoc exploratory analyses we were unable to identify any clear effect of BMI on PFS. The tolerability of BEV + systemic CT for advanced OC appeared to be influenced by BMI.
Clinical trial identification
Legal entity responsible for the study
Roche Pharma AG
Roche Pharma AG
J. Sehouli: Membership on advisory board or board of directors: AstraZeneca, Roche, OBI Pharma, Pfizer, Clovis, NovoCure. A. Mustea: Membership on advisory board or board of directors: Roche. S. Klawitter, A. Wegenaer: Employment: Roche Pharma AG. P. Wimberger: Membership on advisory board or board of directors: Roche, Novartis, Amgen, AstraZeneca, MSD, TEVA, PharmaMar, Fresenius Biotech; Corporate-sponsored research: Roche, Novartis, Amgen, Fresenius Biotech, MSD. All other authors have declared no conflicts of interest.