Management of antiangiogenics’ renovascular safety in ovarian cancer subgroup and intermediate results of the MARS study.

Abstract

5067 Background: Anti-VEGF drugs (AVD) are widely used in cancer patients (pts). Hypertension (HTN) and proteinuria (Pu) are class-side-effects of AVD, related to the inhibition of the VEGF pathway. The MARS study has been conducted to assess the renovascular tolerance of these drugs in the clinical setting. Methods: Hypertension (HTN) and proteinuria (Pu) are class-side-effects of anti-VEGF drugs (AVD), related to the inhibition of the VEGF pathway. The MARS study has been conducted to assess the renovascular tolerance of these drugs in the clinical setting. Results: Among 77 OC pts been included, 38 completed the study to date (1-year follow-up (f/u)). Median age at inclusion (introduction of the AVD) was 62 years. Diabetes and HTN prevalences were 5.2% and 7.9%, respectively. Baseline renal assessment retrieved: Pu 13.2%, Hu 7.9%, mean aMDRD 80.9 ml/min/1.73m2 and 3 pts with aMDRD<60. The incidence of de novo Pu during f/u was 36.4% (Table). All pts with Pu at inclusion improved, except one. Among pts with de novo Pu, 58.3% afterwards improved/normalized. No Grade 3/4 Pu has been reported (at inclusion or during f/u) and no Hu. 17.1% developed HTN. In addition, a mean renal function decrease of -2.7 ml/min/1.73m2/year was observed and 4 pts had aMDRD<60 at the end of f/u. 36.4% had grade 1 SCr increase (median increase of 15.9%) No thrombotic micro-angiopathy (TMA) has been reported. Conclusions: The results of the MARS subgroup of OC pts shows that 1) TMA remains rare, 2) Pu develops in 36.4% of the pts, however with no Grade 3/4, 3) less than 20% developed HTN, and 4) renal function was not especially impaired. Furthermore, in case of a renovascular effect, investigators followed the recommendations from the French Society of Nephrology (Halimi JM et Al. Nephrol Ther 2008) and no treatment withdrawal for unmanageable renovascular toxicity occurred. [Table: see text]