title: Can elderly patients with newly diagnosed glioblastoma be enrolled in radiochemotherapy trials?
abstract: OBJECTIVE
  Age is an unfavorable prognostic factor in glioblastoma multiforme (GBM). To assess the possibility and the advantage of radiotherapy (RT) plus concomitant/sequential temozolomide (TMZ) in patients over 65 years with GBM, we analyzed 4 prospective trials in terms of compliance and outcomes.
  
  
  METHODS
  Elderly patients with histologically proven GBM, included in 4 prospective phase II studies with a Karnofsky Performance Status (KPS) >70 and a Charlson Comorbidity Index (CCI) <3, were selected for these analyses. Patients were treated by 3D-conformal RT (60 Gy), fractionated stereotactic conformal-RT (69.4 Gy), or intensity-modulated RT with simultaneous integrated boost (63 Gy). Concomitant (standard modality, first and last week, or from the Monday to Friday) and adjuvant chemotherapy with TMZ was administered. To stratify patients, recursive partitioning analysis was used. Safety and tolerability were measured by the National Cancer Institute Common Criteria. Progression-free survival (PFS) and overall survival (OS) were calculated by Kaplan-Meier method.
  
  
  RESULTS
  From 2001 to 2011, 201 patients were enrolled in 4 trials and 111 elderly patients were recruited for this analysis. Compliance was 96.4%: 4/111 patients discontinued treatment, prevalently for disease progression. During radiochemotherapy, acute toxicity was mild. At a median follow-up of 64 months (range, 9 to 122 mo), median PFS and OS were 10 and 13 months, respectively. Extent of surgery (P=0.009) and radiation dose (P=0.01) significantly improved survival.
  
  
  CONCLUSIONS
  Radiochemotherapy is effective and well tolerated by elderly patients when KPS >70 and CCI <3; therefore these criterions should be considered to enroll elderly patients in combined prospective study.
authors: *Department of Radiation Oncology, IRCCS/CROB, Rionero in Vulture (PZ) Departments of †Radiation Oncology ‡Neurosurgery, Catholic University of Sacred Heart, Rome, Italy.
authors: Alba
authors: A
authors: Fiorentino
authors: Mario
authors: M
authors: Balducci
authors: Pasquale
authors: P
authors: De Bonis
authors: Silvia
authors: S
authors: Chiesa
authors: Laura
authors: L
authors: De Filippo
authors: Annunziato
authors: A
authors: Mangiola
authors: Fiorenza
authors: F
authors: De Rose
authors: Rosa
authors: R
authors: Autorino
authors: Carla
authors: C
authors: Rinaldi
authors: Sergio
authors: S
authors: Fersino
authors: Barbara
authors: B
authors: Diletto
authors: Paolo
authors: P
authors: Matteucci
authors: Elisa
authors: E
authors: Ciurlia
authors: Vincenzo
authors: V
authors: Fusco
authors: Carmelo
authors: C
authors: Anile
authors: Vincenzo
authors: V
authors: Valentini
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D018906:Antineoplastic Agents, Alkylating / Q000627:therapeutic use*; D001932:Brain Neoplasms / Q000628:therapy*; D059248:Chemoradiotherapy / Q000379:methods*; D059186:Chemoradiotherapy, Adjuvant / Q000379:methods; D003606:Dacarbazine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D018572:Disease-Free Survival; D005260:Female; D005909:Glioblastoma / Q000628:therapy*; D006801:Humans; D053208:Kaplan-Meier Estimate; D017567:Karnofsky Performance Status; D008297:Male; D018579:Patient Selection; D020266:Radiotherapy, Conformal / Q000379:methods; D012189:Retrospective Studies; D000077204:Temozolomide; D016896:Treatment Outcome
chemical_list: D018906:Antineoplastic Agents, Alkylating; D003606:Dacarbazine; D000077204:Temozolomide