NRG/RTOG 0837: Randomized, phase II, double-blind, placebo-controlled trial of chemoradiation with or without cediranib in newly diagnosed glioblastoma.
Neurooncol Adv
; 5(1): vdad116, 2023.
Article
in En
| MEDLINE
| ID: mdl-38024244
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 21 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 Z test for 2 proportions. Adverse events (AEs) were evaluated per CTCAE version 4.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 (Pâ =â .005). There was no significant difference in overall survival between the 2 arms. There was more gradeâ ≥â 3 AEs in the cediranib arm than in the placebo arm (Pâ =â .02).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.
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Language:
En
Journal:
Neurooncol Adv
Year:
2023
Document type:
Article
Affiliation country:
Estados Unidos