Preliminary results of the VENUS study: Bevacizumab efficacy and safety in recurrent, platinum-sensitive ovarian cancer—A real-life ambispective study.
e17093 Background: The aim of the VENUS study was to report on the efficacy/safety of bevacizumab (Bev) in recurrent, platinum-sensitive, ovarian cancer (OC). Methods: VENUS is a multicentric, observational, ambispective study which included both retrospective and prospectice patients (pts). Pts were all naive of any antiVEGF. This analysis presents the results of the retrospective cohort (52 pts) included from 2009 to 2013, with a 3-year follow-up (f/u). Results: Among 148 OC pts included (27 centres), 52 were retrospective. At inclusion, median age: 62.5 years; hypertension according to medical records with or without blood pressure (BP): 30.8%; proteinuria (Pu): 60.0%; abnormal BP (according to NCI-CTCAE 4.03): 71.0%. Mean duration of Bev: 12.7 months. Mean overall survival (OS) and progression free survival (PFS) were respectively 29.4 and 12.9 months. Safety results are presented in the Table. Univariate analysis reported that, at inclusion, Hb<10 g/dL (anemia), ascites and low hematocrit were prognostic of poorer OS. Anemia and TMA (thrombotic microangiopathy) were prognostic of poorer PFS. Multivariate analysis reported that anemia at inclusion was prognostic of poorer OS and PFS. Conclusions: The preliminary results of VENUS (retrospective cohort pts in real life), show that OS and PFS are consistent with what clinical trials reported (29.4 and 12.9 months, respectively). In addition, de novo severe side-effects (grade 3-4 and TMA) were rare, and usual side effects (HTN, Pu) were common but were neither associated with OS nor with PFS. Safety/medical history of VENUS pts. [Table: see text]