title: Outcomes and prognostic factors in recurrent glioma patients enrolled onto phase II clinical trials.
abstract: OBJECTIVE
  To determine aggregate outcomes and prognostic covariates in patients with recurrent glioma enrolled onto phase II chemotherapy trials.
  
  
  METHODS
  Patients from eight consecutive phase II trials included 225 with recurrent glioblastoma multiforme (GBM) and 150 with recurrent anaplastic astrocytoma (AA). Their median age was 45 years (range, 15 to 82 years) and their median Karnofsky performance score was 80 (range, 60 to 100). Prognostic covariates were analyzed with respect to tumor response, progression-free survival (PFS), and overall survival (OS) by multivariate logistic and Cox proportional hazards regression analyses.
  
  
  RESULTS
  Overall, 34 (9%) had complete or partial response, whereas 80 (21%) were alive and progression-free at 6 months (APF6). The median PFS was 10 weeks and median OS was 30 weeks. Histology was a robust prognostic factor across all outcomes. GBM patients had significantly poorer outcomes than AA patients. The APF6 proportion was 15% for GBM and 31% for AA, whereas the median PFS was 9 weeks for GBM and 13 weeks for AA. Results were also significantly poorer for patients with more than two prior surgeries or chemotherapy regimens.
  
  
  CONCLUSIONS
  Histology is a dominant factor in determining outcome in patients with recurrent glioma enrolled onto phase II trials. Future trials should be designed with separate histology strata.
authors.affiliation: Departments of Neuro-Oncology and Biomathematics, The University of Texas M.D. Anderson Cancer Center, Houston, TX 77030, USA.
authors.forename: E T
authors.initials: ET
authors.lastname: Wong
authors.forename: K R
authors.initials: KR
authors.lastname: Hess
authors.forename: M J
authors.initials: MJ
authors.lastname: Gleason
authors.forename: K A
authors.initials: KA
authors.lastname: Jaeckle
authors.forename: A P
authors.initials: AP
authors.lastname: Kyritsis
authors.forename: M D
authors.initials: MD
authors.lastname: Prados
authors.forename: V A
authors.initials: VA
authors.lastname: Levin
authors.forename: W K
authors.initials: WK
authors.lastname: Yung
mesh_terms: D000293:Adolescent; D000328:Adult; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001254:Astrocytoma / Q000145:classification / Q000188:drug therapy* / Q000473:pathology*; D001932:Brain Neoplasms / Q000145:classification / Q000188:drug therapy* / Q000473:pathology; D005909:Glioblastoma / Q000145:classification / Q000188:drug therapy* / Q000473:pathology*; D006801:Humans; D017567:Karnofsky Performance Status; D016015:Logistic Models; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local; D011336:Probability; D011379:Prognosis; D016016:Proportional Hazards Models; D016879:Salvage Therapy; D016896:Treatment Outcome