NRG/RTOG 0837: Randomized, phase II, double-blind, placebo-controlled trial of chemoradiation with or without cediranib in newly diagnosed glioblastoma

Tracy T. Batchelor, Minhee Won, Arnab Chakravarti, Costas G. Hadjipanayis, Wenyin Shi, Lynn S. Ashby, Volker W. Stieber, H. Ian Robins, Heidi J. Gray, Alfredo Voloschin, John B. Fiveash, Clifford G. Robinson, Usha Sree Chamarthy, Young Kwok, Terrence P. Cescon, Anand K. Sharma, Rekha Chaudhary, Mei Yin Polley, Minesh P. Mehta

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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 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 (P = .005). There was no significant difference in overall survival between the 2 arms. There was more grade ≥ 3 AEs in the cediranib arm than in the placebo arm (P = .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.

Original languageEnglish
Article numbervdad116
JournalNeuro-Oncology Advances
Volume5
Issue number1
DOIs
StatePublished - Jan 1 2023

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