Phase II study of aflibercept in recurrent malignant glioma: A North American brain tumor consortium study Journal Article


Authors: De Groot, J. F.; Lamborn, K. R.; Chang, S. M.; Gilbert, M. R.; Cloughesy, T. F.; Aldape, K.; Yao, J.; Jackson, E. F.; Lieberman, F.; Robins, H. I.; Mehta, M. P.; Lassman, A. B.; De Angelis, L. M.; Yung, W. K. A.; Chen, A.; Prados, M. D.; Wen, P. Y.
Article Title: Phase II study of aflibercept in recurrent malignant glioma: A North American brain tumor consortium study
Abstract: Purpose: Antivascular endothelial growth factor (anti-VEGF) therapy is a promising treatment approach for patients with recurrent glioblastoma. This single-arm phase II study evaluated the efficacy of aflibercept (VEGF Trap), a recombinantly produced fusion protein that scavenges both VEGF and placental growth factor in patients with recurrent malignant glioma. Patients and Methods: Forty-two patients with glioblastoma and 16 patients with anaplastic glioma who had received concurrent radiation and temozolomide and adjuvant temozolomide were enrolled at first relapse. Aflibercept 4 mg/kg was administered intravenously on day 1 of every 2-week cycle. Results: The 6-month progression-free survival rate was 7.7% for the glioblastoma cohort and 25% for patients with anaplastic glioma. Overall radiographic response rate was 24% (18% for glioblastoma and 44% for anaplastic glioma). The median progression-free survival was 24 weeks for patients with anaplastic glioma (95% CI, 5 to 31 weeks) and 12 weeks for patients with glioblastoma (95% CI, 8 to 16 weeks). A total of 14 patients (25%) were removed from the study for toxicity, on average less than 2 months from treatment initiation. The main treatment-related National Cancer Institute Common Terminology Criteria grades 3 and 4 adverse events (38 total) included fatigue, hypertension, and lymphopenia. Two grade 4 CNS ischemias and one grade 4 systemic hemorrhage were reported. Aflibercept rapidly decreases permeability on dynamic contrast enhanced magnetic resonance imaging, and molecular analysis of baseline tumor tissue identified tumor-associated markers of response and resistance. Conclusion: Aflibercept monotherapy has moderate toxicity and minimal evidence of single-agent activity in unselected patients with recurrent malignant glioma. © 2011 by American Society of Clinical Oncology.
Journal Title: Journal of Clinical Oncology
Volume: 29
Issue: 19
ISSN: 0732-183X
Publisher: American Society of Clinical Oncology  
Date Published: 2011-07-01
Start Page: 2689
End Page: 2695
Language: English
DOI: 10.1200/jco.2010.34.1636
PROVIDER: scopus
PMCID: PMC3139373
PUBMED: 21606416
DOI/URL:
Notes: --- - "Export Date: 17 August 2011" - "CODEN: JCOND" - "Source: Scopus"
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  1. Andrew Lassman
    111 Lassman