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Phase III randomized trial comparing the efficacy of cediranib as monotherapy, and in combination with lomustine, versus lomustine alone in patients with recurrent glioblastoma

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...

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Main Authors: Batchelor, Tracy T. (Author) , Mulholland, Paul (Author) , Neyns, Bart (Author) , Nabors, L. Burt (Author) , Campone, Mario (Author) , Wick, Antje (Author) , Mason, Warren (Author) , Mikkelsen, Tom (Author) , Phuphanich, Surasak (Author) , Ashby, Lynn S. (Author) , DeGroot, John (Author) , Gattamaneni, Rao (Author) , Cher, Lawrence (Author) , Rosenthal, Mark (Author) , Payer, Franz (Author) , Jürgensmeier, Juliane M. (Author) , Jain, Rakesh K. (Author) , Sorensen, A. Gregory (Author) , Xu, John (Author) , Liu, Qi (Author) , van den Bent, Martin (Author)
Format: Article (Journal) Conference Paper
Language:English
Published: August 12, 2013
In: Journal of clinical oncology
Year: 2013, Volume: 31, Issue: 26, Pages: 3212-3218
ISSN:1527-7755
DOI:10.1200/JCO.2012.47.2464
Online Access:Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1200/JCO.2012.47.2464
Verlag, lizenzpflichtig, Volltext: https://ascopubs.org/doi/10.1200/JCO.2012.47.2464
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Author Notes:Tracy T. Batchelor, Paul Mulholland, Bart Neyns, L. Burt Nabors, Mario Campone, Antje Wick, Warren Mason, Tom Mikkelsen, Surasak Phuphanich, Lynn S. Ashby, John DeGroot, Rao Gattamaneni, Lawrence Cher, Mark Rosenthal, Franz Payer, Juliane M. Jürgensmeier, Rakesh K. Jain, A. Gregory Sorensen, John Xu, Qi Liu, and Martin van den Bent
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Summary: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.
Item Description:Gesehen am 10.11.2020
Presented in part at the 2010 Congress of the European Society of Medical Oncology, October 8-12, 2010, Milan,Italy, and the Society of Neuro-Oncology 15th Annual Scientific Meet-ing, November 18-21, 2010, Montreal,Quebec, Canada
Physical Description:Online Resource
ISSN:1527-7755
DOI:10.1200/JCO.2012.47.2464

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