title: Dendritic cell vaccination in glioblastoma after fluorescence-guided resection.
abstract: OBJECTIVE
  To assess whether the addition of a customized, active immunotherapy to standard of care including fluorescence-guided surgery, may provide hints of an improved survival for patients with poor-prognosis, incurable glioblastoma multiform.
  
  
  METHODS
  Preliminary to our ongoing, phase-II clinical trial, we conducted a small pilot study enrolling five consecutive patients with resectable glioblastoma. In terms of Recursive Partitioning Analysis, four patients were class V and one was class IV. In all five cases, fluorescence-guided surgery was employed, followed by rapid steroid discontinuation. Patients were then treated with a combination of standard radio-chemotherapy with temozolomide and tumor lysate-pulsed, mature dendritic cell-based vaccinations.
  
  
  RESULTS
  Though all five patients ultimately progressed, with any further treatment left to the sole decision of the treating oncologist, active immunotherapy was very well tolerated and induced specific immune responses in all three patients for whom enough material was available for such an assessment. Median progression-free survival was 16.1 mo. Even more important, median and mean overall survival were 27 mo and 26 mo, respectively. Three patients have died with an overall survival of 9 mo, 27 mo and 27.4 mo, while the other two are still alive at 32 mo and 36 mo, the former receiving treatment with bevacizumab, while the latter has now been off therapy for 12 mo. Four of five patients were alive at two years.
  
  
  CONCLUSIONS
  Active immunotherapy with tumor lysate-pulsed, autologous dendritic cells is feasible, safe, well tolerated and biologically efficacious. A phase-II study is ongoing to possibly improve further on our very encouraging clinical results.
authors.affiliation: Ricardo Diez Valle, Sonia Tejada, Department of Neurosurgery, University of Navarra Hospital, 31008 Pamplona, Navarra, Spain.
authors.forename: Ricardo Diez
authors.initials: RD
authors.lastname: Valle
authors.forename: Ascension Lopez-Diaz
authors.initials: AL
authors.lastname: de Cerio
authors.forename: Susana
authors.initials: S
authors.lastname: Inoges
authors.forename: Sonia
authors.initials: S
authors.lastname: Tejada
authors.forename: Fernando
authors.initials: F
authors.lastname: Pastor
authors.forename: Helena
authors.initials: H
authors.lastname: Villanueva
authors.forename: Jaime
authors.initials: J
authors.lastname: Gallego
authors.forename: Jaime
authors.initials: J
authors.lastname: Espinos
authors.forename: Javier
authors.initials: J
authors.lastname: Aristu
authors.forename: Miguel Angel
authors.initials: MA
authors.lastname: Idoate
authors.forename: Enrique
authors.initials: E
authors.lastname: Andreu
authors.forename: Maurizio
authors.initials: M
authors.lastname: Bendandi
keywords: Dendritic cells; Fluorescence-guided surgery; Glioblastoma; Immunotherapy; Tumor-lysate