A phase II of everolimus and octreotide for patients with refractory and documented progressive meningioma (CEVOREM).

2011Background: After iterative surgeries and radiotherapy (RT)/radiosurgery (RS) failure, aggressive meningiomas remain an unmet medical need. We have shown in vitro that everolimus (EVE) combined to octreotide (OCT) is active in meningiomas. Methods: Prospective multicentric single arm phase II study (NCT02333565) including pts with recurrent meningioma with documented progression ( > 10% increase of tumor surface over 6 months) after surgery and RT/RS. EVE was orally administrated at 10mg/day and OCT by IM injection 30 mg/28 days. MRI was performed every 3 months with planned central review of imaging including volumetric progression at inclusion and during treatment. The primary endpoint was PFS6. The criteria for success was defined as a PFS6 > 40%. Results: 20 pts were included, aged 30-75 years (median 55) with 37 progressive intra cranial meningiomas (WHO: 2 grade I, 27 grade II, 8 grade III) including 4 NF2 pts. Median KPS was 70%. All pts previously underwent at least one surgery and more than 1...