Phase II study of Gleevec^sup ?^ plus hydroxyurea (HU) in adults with progressive or recurrent meningioma

• Published in: Journal of neuro-oncology 2012-01, Vol.106 (2), p.409
• Main Authors: Reardon, David A, Norden, Andrew D, Desjardins, Annick, Vredenburgh, James J, Herndon, James E, Coan, April, Sampson, John H, Gururangan, Sridharan, Peters, Katherine B, Mclendon, Roger E, Norfleet, Julie A, Lipp, Eric S, Drappatz, Jan, Wen, Patrick Y, Friedman, Henry S
• Format: Article
• Language: English
• ISSN: 0167-594X; 1573-7373
• DOI: 10.1007/s11060-011-0687-1

We prospectively evaluated the efficacy and safety of imatinib plus hydroxyurea in patients with progressive/recurrent meningioma. A total of 21 patients with progressive/recurrent meningioma were enrolled in this dual center, single-arm, phase II trial. All patients received 500 mg of hydroxyurea twice a day. Imatinib was administered at 400 mg/day for patients not on CYP3A enzyme inducing anti-epileptic drugs (EIAEDs) and at 500 mg twice a day for patients on EIAEDs. The primary endpoint was progression-free survival at 6 months (PFS-6) and secondary endpoints were safety, radiographic response rate, and overall survival (OS). Best radiographic response was stable disease and was observed in 14 patients (67%). PFS-6 for all patients, those with grade I tumors (n = 8) and those with grade II or III tumors (n = 13) was 61.9, 87.5 and 46.2%, respectively. Patients with grade II or III tumors had poorer PFS and OS than those with grade I tumors, (P = 0.025 and P = 0.018) respectively. The only grade 3 or greater adverse event occurring in ≥10% of patients was anemia (10%). Imatinib plus hydroxyurea is well tolerated among patients with meningioma but has modest anti-tumor activity for this indication.[PUBLICATION ABSTRACT]