Phase II trials of erlotinib or gefitinib in patients with recurrent meningiomas

Abstract

2062 Background: No effective treatment is available for recurrent meningiomas when surgical and radiation options are exhausted. The epidermal growth factor receptor (EGFR) is often over-expressed in meningiomas and may promote tumor growth. In open label, single arm phase II studies of the EGFR inhibitors gefitinib (NABTC 00–01) and erlotinib (NABTC 01–03) for recurrent malignant gliomas, we included exploratory subsets of recurrent meningioma patients. We have pooled the data and report the results here. Methods: Patients with recurrent histologically confirmed meningiomas and no more than two previous chemotherapy regimens were treated with gefitinib 500 mg/day or erlotinib 150 mg/day until tumor progression or unacceptable toxicity. Results: Twenty-five eligible patients were enrolled with median age 57 years (range 29–81) and median Karnofsky performance status (KPS) score 90 (range 60–100). Sixteen patients (64%) received gefitinib and nine (36%) erlotinib. Eight patients (32%) had benign tumors, 9 (36%) atypical, and eight (32%) malignant. For benign tumors, the 6-month progression-free survival (PFS6) was 29%, 12-month PFS (PFS12) 0%, 6-month overall survival (OS6) 63%, and 12-month OS (OS12) 50%. For atypical/malignant tumors, PFS6 was 25%, PFS12 19%, OS6 81%, and OS12 68%. There were no significant PFS or OS differences by histology. Of 21 evaluable patients, there were no responses; eight patients (38%) had stable disease, and 13 (62%) had progressive disease. Treatment was well-tolerated. Rash was not a significant predictor of PFS or OS. Conclusions: Neither gefitinib nor erlotinib appear to have significant activity against recurrent meningioma. The role of EGFR inhibitors in meningiomas is unclear but evaluation of EGFR inhibitors in combination with other targeted molecular agents may be warranted. No significant financial relationships to disclose.