CTNI-54. PHASE Ⅱ TRIAL ON APATINIB TREATING FOR RECURRENT OR PROGRESSIVE HIGH-GRADE MENINGIOMA

Abstract So far, no effective chemotherapy or molecular targeted therapy are available for recurrent or progressive high-grade meningioma. Apatinib is an oral small-molecule tyrosine kinase inhibitor that targets vascular endothelial growth factor receptor-2 (VEGFR-2). In this single-arm phase II trial, patients with recurrent or progressive high-grade meningioma (WHO grade 2 or 3) after maximum safe resection and prior radiotherapy were administered oral apatinib at 500 mg daily (28 days as one cycle). Patients remained on the treatment unless they experienced disease progression or unacceptable toxicity, or withdrew informed consent. The maximum number of cycles shall not exceed 24. The primary endpoint was the rate of 6-month progression-free survival (PFS). The secondary endpoints included objective response rate (ORR), disease control rate (DCR), PFS, overall survival (OS) and safety. A total of 11 patients were enrolled. The rate of 6-month PFS was 77.8%, and the rate of 12-month OS was 87.5%. The median PFS lasted for 19.5 months (95% CI: 16.3-22.6 months) and the median OS was 27.2 months (95% CI: 20.0-34.3 months). Among the 9 patients available for efficacy assessment, 3 patients got partial response, 3 got minor response, and 3 got stable disease. The median treatment duration lasted for 17 cycles. The ORR was 66.6% and the DCR was 100%. The most common grade 3 or 4 toxicities were hypertension, anorexia and proteinuria. The adverse events were manageable. Our preliminary results showed treatment with apatinib achieved prolonged median PFS and OS in patients with recurrent or progressive high-grade meningioma, the related toxicities being manageable. Further investigation involving larger-size cohort is warranted to confirm the the efficacy of apatinib in this patient population.