Department
neurology
Document Type
Article
Abstract
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/m2); (3) lomustine (110 mg/m2) 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.
Medical Subject Headings
neurology
Publication Date
2013
Publication Title
Journal of Clinical Oncology
ISSN
0732-183X
Volume
31
Issue
26
First Page
3212
Last Page
3218
Digital Object Identifier (DOI)
10.1200/JCO.2012.47.2464
Recommended Citation
Batchelor, Tracy T.; Mulholland, Paul; Neyns, Bart; Nabors, L. Burt; Campone, Mario; Wick, Antje; Mason, Warren; Mikkelsen, Tom; Phuphanich, Surasak; Ashby, Lynn S.; DeGroot, John; Gattamaneni, Rao; Cher, Lawrence; Rosenthal, Mark; Payer, Franz; Jürgensmeier, Juliane M.; Jain, Rakesh K.; Sorensen, A. Gregory; Xu, John; and al., et, "Phase III Randomized Trial Comparing the Efficacy of Cediranib as Monotherapy and in Combination With Lomustine Versus Lomustine Alone in Patients With Recurrent Glioblastoma" (2013). Neurology. 145.
https://scholar.barrowneuro.org/neurology/145