title: Phase II Radiation Therapy Oncology Group trial of conventional radiation therapy followed by treatment with recombinant interferon-beta for supratentorial glioblastoma: results of RTOG 9710.
abstract: OBJECTIVE
  The aim of this study was to determine whether recombinant human interferon beta-1a (rhIFN-beta), when given after radiation therapy, improves survival in glioblastoma.
  
  
  METHODS
  After surgery, 109 patients with newly diagnosed supratentorial glioblastoma were enrolled and treated with radiation therapy (60 Gy). A total of 55 patients remained stable after radiation and were treated with rhIFN-beta (6 MU/day i.m., 3 times/week). Outcomes were compared with the Radiation Therapy Oncology Group glioma historical database.
  
  
  RESULTS
  RhIFN-beta was well tolerated, with 1 Grade 4 toxicity and 8 other patients experiencing Grade 3 toxicity. Median survival time (MST) of the 55 rhIFN-beta-treated patients was 13.4 months. MST for the 34 rhIFN-beta-treated in RPA Classes III and IV was 16.9 vs. 12.4 months for historical controls (hazard ratio [HR] = 1.27, 95% confidence interval [CI] = 0.89-1.81). There was also a trend toward improved survival across all RPA Classes comparing the 55 rhIFN-beta treated patients and 1,658 historical controls (HR = 1.24, 95% CI = 0.94-1.63). The high rate of early failures (54/109) after radiation and before initiation of rhIFN-beta was likely caused by stricter interpretation of early radiographic changes in the current study. Matched-pair and intent-to-treat analyses performed to try to address this bias showed no difference in survival between study patients and controls.
  
  
  CONCLUSIONS
  RhIFN-beta given after conventional radiation therapy was well tolerated, with a trend toward survival benefit in patients who remained stable after radiation therapy. These data suggest that rhIFN-beta warrants further evaluation in additional studies, possibly in combination with current temozolomide-based regimens.
authors.affiliation: Department of Neuro-Oncology, University of Texas-M. D. Anderson Cancer Center, Houston, TX 77030, USA. hcolman@mdanderson.org
authors.forename: Howard
authors.initials: H
authors.lastname: Colman
authors.forename: Brian A
authors.initials: BA
authors.lastname: Berkey
authors.forename: Moshe H
authors.initials: MH
authors.lastname: Maor
authors.forename: Morris D
authors.initials: MD
authors.lastname: Groves
authors.forename: Christopher J
authors.initials: CJ
authors.lastname: Schultz
authors.forename: Sandra
authors.initials: S
authors.lastname: Vermeulen
authors.forename: Diana F
authors.initials: DF
authors.lastname: Nelson
authors.forename: Minesh P
authors.initials: MP
authors.lastname: Mehta
authors.forename: W K Alfred
authors.initials: WK
authors.lastname: Yung
mesh_terms: D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001932:Brain Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000532:radiotherapy; D003131:Combined Modality Therapy / Q000379:methods; D016001:Confidence Intervals; D005260:Female; D005909:Glioblastoma / Q000188:drug therapy* / Q000401:mortality / Q000532:radiotherapy; D006801:Humans; D007370:Interferon Type I / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D016016:Proportional Hazards Models; D011994:Recombinant Proteins; D012044:Regression Analysis; D015173:Supratentorial Neoplasms / Q000188:drug therapy / Q000401:mortality / Q000532:radiotherapy
chemical_list: D000970:Antineoplastic Agents; D007370:Interferon Type I; D011994:Recombinant Proteins