title: Corticosteroid use in patients with glioblastoma at first or second relapse treated with bevacizumab in the BRAIN study.
abstract: BACKGROUND
  Vascular endothelial growth factor inhibitors have corticosteroid-sparing effects in patients with high-grade gliomas. We assessed corticosteroid use in patients with recurrent glioblastoma treated with bevacizumab (BEV) in the BRAIN study (J Clin Oncol 2009;27:4733-4740).
  
  
  METHODS
  BRAIN was a phase II, multicenter, randomized, noncomparative trial of BEV alone (n = 85) or in combination with irinotecan (CPT-11) (n = 82) in adults with recurrent glioblastoma. Median corticosteroid dose for patients who used corticosteroids at baseline was summarized by treatment arm; the percentage of patients who had sustained (≥50% corticosteroid dose reduction for ≥50% of time on study drug) or complete (discontinuation of corticosteroid for ≥25% of time on study drug) reduction in corticosteroid dose overall and by objective response and progression-free survival was calculated. The incidence of corticosteroid-related adverse events was summarized.
  
  
  RESULTS
  In each treatment group, 50% of patients were using systemic corticosteroids at baseline. The majority of those experienced a reduction in dose while receiving BEV-based therapy. Thirteen (30.2%) BEV and 20 (46.5%) BEV + CPT-11 patients had a sustained reduction of corticosteroid dose; 7 (16.3%) BEV and 9 (20.9%) BEV + CPT-11 patients had a complete reduction of corticosteroid dose. The majority of patients who had an objective response or progression-free survival >6 months experienced corticosteroid dose reduction. Approximately 64% of patients who used corticosteroids while receiving BEV-based therapy experienced infection.
  
  
  CONCLUSIONS
  BEV may have corticosteroid-sparing effects in patients with recurrent glioblastoma. Corticosteroid reduction may positively affect patient health-related quality of life. Given the exploratory nature of the analyses in a noncomparative study, these results should be interpreted cautiously.
authors.affiliation: Preston Robert Tisch Brain Tumor Center at Duke, Duke University Medical Center, Durham, NC 27710, USA. vrede001@mc.duke.edu
authors.forename: James J
authors.initials: JJ
authors.lastname: Vredenburgh
authors.forename: Timothy
authors.initials: T
authors.lastname: Cloughesy
authors.forename: Meghna
authors.initials: M
authors.lastname: Samant
authors.forename: Michael
authors.initials: M
authors.lastname: Prados
authors.forename: Patrick Y
authors.initials: PY
authors.lastname: Wen
authors.forename: Tom
authors.initials: T
authors.lastname: Mikkelsen
authors.forename: David
authors.initials: D
authors.lastname: Schiff
authors.forename: Lauren E
authors.initials: LE
authors.lastname: Abrey
authors.forename: W K Alfred
authors.initials: WK
authors.lastname: Yung
authors.forename: Nina
authors.initials: N
authors.lastname: Paleologos
authors.forename: Martin K
authors.initials: MK
authors.lastname: Nicholas
authors.forename: Randy
authors.initials: R
authors.lastname: Jensen
authors.forename: Asha
authors.initials: A
authors.lastname: Das
authors.forename: Henry S
authors.initials: HS
authors.lastname: Friedman
mesh_terms: D000305:Adrenal Cortex Hormones / Q000627:therapeutic use*; D000328:Adult; D020533:Angiogenesis Inhibitors / Q000627:therapeutic use*; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D000068258:Bevacizumab; D001932:Brain Neoplasms / Q000188:drug therapy* / Q000473:pathology; D005260:Female; D005909:Glioblastoma / Q000188:drug therapy* / Q000473:pathology; D006801:Humans; D008207:Lymphatic Metastasis; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy* / Q000473:pathology; D009367:Neoplasm Staging; D016879:Salvage Therapy; D015996:Survival Rate; D016896:Treatment Outcome; D042461:Vascular Endothelial Growth Factor A / Q000037:antagonists & inhibitors / Q000378:metabolism
chemical_list: D000305:Adrenal Cortex Hormones; D020533:Angiogenesis Inhibitors; D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D042461:Vascular Endothelial Growth Factor A; D000068258:Bevacizumab