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Clinical Trial
. 2010 Jan;96(2):211-7.
doi: 10.1007/s11060-009-9948-7. Epub 2009 Jun 28.

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

Andrew D Norden  1 , Jeffrey J Raizer, Lauren E Abrey, Kathleen R Lamborn, Andrew B Lassman, Susan M Chang, W K Alfred Yung, Mark R Gilbert, Howard A Fine, Minesh Mehta, Lisa M Deangelis, Timothy F Cloughesy, H Ian Robins, Kenneth Aldape, Janet Dancey, Michael D Prados, Frank Lieberman, Patrick Y Wen
Affiliations
Clinical Trial

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

Andrew D Norden et al. J Neurooncol. 2010 Jan.

Abstract

There are no established treatments for recurrent meningioma 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. Patients with recurrent histologically confirmed meningiomas with no more than 2 previous chemotherapy regimens were treated with gefitinib 500 mg/day or erlotinib 150 mg/day until tumor progression or unacceptable toxicity. 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 9 (36%) erlotinib. Eight patients (32%) had benign tumors, 9 (36%) atypical, and 8 (32%) malignant. For benign tumors, the 6-month progression-free survival (PFS6) was 25%, 12-month PFS (PFS12) 13%, 6-month overall survival (OS6) 63%, and 12-month OS (OS12) 50%. For atypical and malignant tumors, PFS6 was 29%, PFS12 18%, OS6 71%, and OS12 65%. The PFS and OS were not significantly different by histology. There were no objective imaging responses, but 8 patients (32%) maintained stable disease. Although treatment was well-tolerated, neither gefitinib nor erlotinib appear to have significant activity against recurrent meningioma. The role of EGFR inhibitors in meningiomas is unclear. Evaluation of multi-targeted inhibitors and EGFR inhibitors in combination with other targeted molecular agents may be warranted.

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Figures

Figure 1
Figure 1
Kaplan-Meier curves showing progression-free and overall survival for the 25 eligible patients.
Figure 2
Figure 2
Kaplan-Meier curves showing progression-free (A) and overall survival (B) for the 25 eligible patients stratified by histologic grade. The differences are not statistically significant.
Figure 2
Figure 2
Kaplan-Meier curves showing progression-free (A) and overall survival (B) for the 25 eligible patients stratified by histologic grade. The differences are not statistically significant.
See this image and copyright information in PMC

References

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