Document Type
Article
Publication Date
10-11-2023
Abstract
BACKGROUND: A randomized, phase II, placebo-controlled, and blinded clinical trial (NCT01062425) was conducted to determine the efficacy of cediranib, an oral pan-vascular endothelial growth factor receptor tyrosine kinase inhibitor, versus placebo in combination with radiation and temozolomide in newly diagnosed glioblastoma.
METHODS: Patients with newly diagnosed glioblastoma were randomly assigned 2:1 to receive (1) cediranib (20 mg) in combination with radiation and temozolomide; (2) placebo in combination with radiation and temozolomide. The primary endpoint was 6-month progression-free survival (PFS) based on blinded, independent radiographic assessment of postcontrast T1-weighted and noncontrast T2-weighted MRI brain scans and was tested using a 1-sided
RESULTS: One hundred and fifty-eight patients were randomized, out of which 9 were ineligible and 12 were not evaluable for the primary endpoint, leaving 137 eligible and evaluable. 6-month PFS was 46.6% in the cediranib arm versus 24.5% in the placebo arm (
CONCLUSIONS: This study met its primary endpoint of prolongation of 6-month PFS with cediranib in combination with radiation and temozolomide versus placebo in combination with radiation and temozolomide. There was no difference in overall survival between the 2 arms.
Recommended Citation
Batchelor, Tracy T.; Won, Minhee; Chakravarti, Arnab; Hadjipanayis, Costas G.; Shi, Wenyin; Ashby, Lynn S.; Stieber, Volker W.; Robins, H. Ian; Gray, Heidi J.; Voloschin, Alfredo; Fiveash, John B.; Robinson, Clifford G.; Chamarthy, UshaSree; Kwok, Young; Cescon, Terrence P.; Sharma, Anand K.; Chaudhary, Rekha; Polley, Mei-Yin; and Mehta, Minesh P., "NRG/RTOG 0837: Randomized, Phase II, Double-Blind, Placebo-Controlled Trial of Chemoradiation With or Without Cediranib in Newly Diagnosed Glioblastoma" (2023). Department of Radiation Oncology Faculty Papers. Paper 183.
https://jdc.jefferson.edu/radoncfp/183
Creative Commons License
This work is licensed under a Creative Commons Attribution 4.0 License.
PubMed ID
38024244
Language
English
Comments
This is the author's final published version in Neuro-Oncology Advances, Volume 5, Issue 1, January-December 2023, Article number vdad116.
The published version is available at https://doi.org/10.1093/noajnl/vdad116. Copyright © The Author(s) 2023. Published by Oxford University Press, the Society for Neuro-Oncology and the European Association of Neuro-Oncology.