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Phase II Study of Aflibercept in Recurrent Malignant Glioma: A North American Brain Tumor Consortium Study .


Posted on: 06/16/2011

   J Clin Oncol. 2011 May 23. [Epub ahead of print]

Phase II Study of Aflibercept in Recurrent Malignant Glioma: A North American Brain Tumor Consortium Study .

de Groot JF, Lamborn KR, Chang SM, Gilbert MR, Cloughesy TF, Aldape K, Yao J, Jackson EF, Lieberman F, Robins HI, Mehta MP, Lassman AB, Deangelis LM, Yung WK, Chen A, Prados MD, Wen PY

Source

John F. de Groot, Mark R. Gilbert, Kenneth Aldape, Jun Yao, Edward F. Jackson, and W.K. Alfred Yung, The University of Texas MD Anderson Cancer Center, Houston, TX; Kathleen R. Lamborn, Susan M. Chang, and Michael D. Prados, University of California, San Francisco, San Francisco; Timothy F. Cloughesy, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, CA; Frank Lieberman, University of Pittsburgh, Pittsburgh, PA; H. Ian Robins, University of Wisconsin Comprehensive Cancer Center, Madison, WI; Minesh P. Mehta, Northwestern University, Evanston, IL; Andrew B. Lassman and Lisa M. DeAngelis, Memorial Sloan-Kettering Cancer Center, New York, NY; Alice Chen, Cancer Treatment Experimental Program, National Cancer Institute, Bethesda, MD; and Patrick Y. Wen, Dana-Farber Cancer Institute and Brigham and Women's Cancer Center, Boston, MA.

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.

 

PMID:
21606416 [PubMed - as supplied by publisher]
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