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NRG/RTOG 1122: A phase 2, double-blinded, placebo-controlled study of bevacizumab with and without trebananib in patients with recurrent glioblastoma or gliosarcoma.
- Source :
-
Cancer [Cancer] 2020 Jun 15; Vol. 126 (12), pp. 2821-2828. Date of Electronic Publication: 2020 Mar 10. - Publication Year :
- 2020
-
Abstract
- Background: Targeting vascular endothelial growth factor (VEGF) alone does not improve overall survival (OS) in recurrent glioblastoma (rGBM). The angiopoiein (Ang)-TIE2 system may play a role in tumor survival under VEGF inhibition. We conducted a phase 2, double-blinded, placebo-controlled trial of bevacizumab plus trebananib (a novel Fc fusion protein that sequesters Ang1/Ang2) over bevacizumab alone in rGBM.<br />Methods: Patients ≥18 years of age with a Karnofsky performance status ≥70 and GBM or variants in first or second relapse were randomized to bevacizumab 10 mg/kg every 2 weeks plus trebananib 15 mg/kg every week or bevacizumab plus placebo. The primary endpoint was 6-month progression-free survival (PFS).<br />Results: After an initial 6-patient lead-in cohort confirmed the safety of combining bevacizumab and trebananib, 115 eligible patients were randomized to the control (n = 58) or experimental treatment (n = 57). In the control arm, 6-month PFS was 41.1%, median survival time was 11.5 months (95% CI, 8.4-14.2 months), median PFS was 4.8 months (95% CI, 3.8-7.1 months), and radiographic response (RR) was 5.9%. In the experimental arm, 6-month PFS was 22.6%, median survival time was 7.5 months (95% CI, 6.8-10.1 months), median PFS was 4.2 months (95% CI, 3.7-5.6 months), and RR was 4.2%. The rate of severe toxicities was not significantly different between arms.<br />Conclusion: The combination of bevacizumab and trebananib was well tolerated but did not significantly improve 6-month PFS rate, PFS, or OS for patients with rGBM over bevacizumab alone. The shorter PFS in the experimental arm with a hazard ratio of 1.51 (P = .04) suggests that the addition of trebananib to bevacizumab is detrimental.<br /> (© 2020 American Cancer Society.)
- Subjects :
- Adult
Aged
Antineoplastic Combined Chemotherapy Protocols adverse effects
Bevacizumab administration & dosage
Double-Blind Method
Female
Glioblastoma mortality
Glioblastoma pathology
Gliosarcoma mortality
Gliosarcoma pathology
Humans
Male
Middle Aged
Placebos
Recombinant Fusion Proteins administration & dosage
Recombinant Fusion Proteins pharmacokinetics
Treatment Outcome
Antineoplastic Combined Chemotherapy Protocols therapeutic use
Glioblastoma drug therapy
Gliosarcoma drug therapy
Subjects
Details
- Language :
- English
- ISSN :
- 1097-0142
- Volume :
- 126
- Issue :
- 12
- Database :
- MEDLINE
- Journal :
- Cancer
- Publication Type :
- Academic Journal
- Accession number :
- 32154928
- Full Text :
- https://doi.org/10.1002/cncr.32811