OS6.6 CEVOREM Trial: Combination of EVerolimus and Octreotide in REsistant MeningiomasPresentation and Preliminary results

Abstract

INTRODUCTION: WHO grade II and III meningiomas in therapeutic failure are a real therapeutic challenge with a rate of progression‐free survival at 6 months closed to 10%. The results of our in vitro studies have demonstrated an additive antiproliferative effect of octreotide and everolimus on meningiomas in primary culture. These results led us to test this combination within the PHRC K‐2013 targeting meningiomas with therapeutic failure despite multiple surgeries and radiation therapy. MATERIALS AND METHODS: 20 patients were included in this two‐center phase II study in 18 months. The eligibility criteria include meningiomas with treatment failure after surgery and radiotherapy and radiological progression documented before inclusion. The expected duration of treatment is one year. The primary endpoint is the PFS6, but the PFS average, the rate of tumor growth, the overall survival and side effects will also be assessed. A central review of imaging is planned. The success criterion of this study is to observe a PFS6> 40%. RESULTS: 20 patients were included in less than a year (18% grade I, grade II 70%, and 12% of grade III). To date, 78 cycles were performed. We note 3 cases of discontinuation for poor tolerance (1 case of 2 drugs discontinuation, 1 case of octreotide discontinuation and 1 case of everolimus discontinuation), and 1 case of discontinuation for progression at 3 months. Among the 6 patients who continued combination therapy 6 months or more, the treatment was discontinued in 1 case for progression. DISCUSSION: The rapid inclusion highlights a real medical need and the feasibility of this protocol. Tolerance of everolimus‐octreotide combination seems acceptable on these preliminary results. Further analysis is required to precise the activity of this combination.