ACTR-43. PILOT STUDY OF OPTUNE (NOVOTTF-100A) FOR RECURRENT ATYPICAL AND ANAPLASTIC MENINGIOMA

Abstract

BACKGROUND:

Medical therapies for surgery and radiotherapy-refractory meningiomas are limited. Optune (NovoTTF-100A) is an external cranial device that produces low intensity, intermediate frequency, alternating electric fields that interfere with cell division and stunt tumor cell growth. Although it is FDA-approved for use in recurrent glioblastoma, its efficacy in recurrent meningioma is unknown.

METHODS:

We conducted a pilot study for patients with recurrent atypical and anaplastic meningioma (WHO grades II–III). Optune is initiated as monotherapy for ≥ 18 hours per day per the established treatment standard. MRI scans are performed every 8 weeks. The primary endpoint is the 6-month progression-free survival (PFS) rate, with secondary endpoints of time to progression, radiographic response, safety and tolerability, overall survival (OS) rate, and volumetric and MR-perfusion correlates.

RESULTS:

To date, 6 patients (3 female) with a median age of 60.4 years (range 27.5–70.2 years) and median KPS of 70 (range 60–100%) have been enrolled. Histologies include 3 recurrent WHO grade II atypical and 3 recurrent WHO grade III anaplastic meningiomas. Median number of recurrences was 5 (range 2–12). All patients had failed prior surgery and radiation. Median PFS was 3.3 months (range 1.0–4.6 months). Best radiographic response was SD (n=4) and PD (n=2); no patient achieved PR or CR. Treatment was well tolerated with no grade 3, 4, or 5 toxicities. Notable toxicities at least possibly related to treatment include: grade 2 skin ulceration (n=2), grade 2 fatigue (n=1), and grade 1 fatigue (n=1). Five patients discontinued treatment due to disease progression; one patient withdrew consent. Median duration of the treatment was 3.7 months (range 1.0–4.6 months).

CONCLUSIONS:

In this heavily pretreated population, 4 of 6 patients attained SD with Optune treatment. Trial accrual is ongoing.