Journal
JOURNAL OF CLINICAL ONCOLOGY
Volume 31, Issue 26, Pages 3212-3218Publisher
AMER SOC CLINICAL ONCOLOGY
DOI: 10.1200/JCO.2012.47.2464
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Funding
- AstraZeneca
- Millennium
- Pfizer
- Mario Campone
- Novartis
- Boehringer Ingelheim
- Apogenix
- Eli Lilly
- Roche
- Merck
- Celgene
- Genetech Oncology
- ImmunoCellular Therapeutics
- Diffusion Pharmaceutical
- Med-Immune
- Myrexis
- Sanofi-Aventis
- EMD-Serono
- Dyax
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Purpose A randomized, phase III, placebo-controlled, partially blinded clinical trial (REGAL [Recentin in Glioblastoma Alone and With Lomustine]) was conducted to determine the efficacy of cediranib, an oral pan-vascular endothelial growth factor (VEGF) receptor tyrosine kinase inhibitor, either as monotherapy or in combination with lomustine versus lomustine in patients with recurrent glioblastoma. Patients and Methods Patients (N = 325) with recurrent glioblastoma who previously received radiation and temozolomide were randomly assigned 2:2:1 to receive (1) cediranib (30 mg) monotherapy; (2) cediranib (20 mg) plus lomustine (110 mg/m(2)); (3) lomustine (110 mg/m(2)) plus a placebo. The primary end point was progression-free survival based on blinded, independent radiographic assessment of postcontrast T1-weighted and noncontrast T2-weighted magnetic resonance imaging (MRI) brain scans. Results The primary end point of progression-free survival (PFS) was not significantly different for either cediranib alone (hazard ratio [HR] = 1.05; 95% CI, 0.74 to 1.50; two-sided P = .90) or cediranib in combination with lomustine (HR = 0.76; 95% CI, 0.53 to 1.08; two-sided P = .16) versus lomustine based on independent or local review of postcontrast T1-weighted MRI. Conclusion This study did not meet its primary end point of PFS prolongation with cediranib either as monotherapy or in combination with lomustine versus lomustine in patients with recurrent glioblastoma, although cediranib showed evidence of clinical activity on some secondary end points including time to deterioration in neurologic status and corticosteroid-sparing effects. (C) 2013 by American Society of Clinical Oncology
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