title: Phase II study of temozolomide without radiotherapy in newly diagnosed glioblastoma multiforme in an elderly populations.
abstract: BACKGROUND
  Currently, the survival of patients age > 70 years with glioblastoma multiforme (GBM) ranges from 4 months to 6 months, although radiotherapy and/or chemotherapy may prolong survival in certain subgroups. Temozolomide is an oral chemotherapeutic agent with efficacy against malignant gliomas and a favorable safety profile. This open-label, single-center, Phase II study was designed to evaluate the efficacy and safety of temozolomide as first-line chemotherapy and exclusive treatment in elderly patients with newly diagnosed GBM.
  
  
  METHODS
  Chemotherapy-naïve patients (age > 70 years) were treated with temozolomide at a dose of 150-200 mg/m(2) per day for 5 consecutive days of a 28-day cycle until they developed disease progression. No radiation therapy was administered. The primary endpoint was median overall survival (OS); secondary endpoints included progression-free survival (PFS) and toxicity.
  
  
  RESULTS
  Thirty-two patients (median age, 75 years; median Karnofsky performance status, 70) experienced a median OS of 6.4 months and a median PFS of 5.0 months. Of 29 patients who were assessed for response, 9 patients (31%) achieved a partial response, 12 patients (41%) maintained stable disease, and 8 patients (28%) developed progressive disease. Adverse events primarily were mild, with NCI CTC Grade 3-4 thrombocytopenia and neutropenia reported to occur in 6% and 9% of patients, respectively. No neurotoxicity was observed. Treatment delays and dose reductions occurred in 13% and 14% of cycles, respectively.
  
  
  CONCLUSIONS
  Temozolomide represents a safe, easily administered, and effective therapeutic approach for elderly patients with newly diagnosed GBM.
authors.affiliation: Service de Neurochirurgie, CHU Timone, Marseille, France. olivier.chinot@ap-hm.fr
authors.forename: Olivier-L
authors.initials: OL
authors.lastname: Chinot
authors.forename: Maryline
authors.initials: M
authors.lastname: Barrie
authors.forename: Elisabeth
authors.initials: E
authors.lastname: Frauger
authors.forename: Henry
authors.initials: H
authors.lastname: Dufour
authors.forename: Dominique
authors.initials: D
authors.lastname: Figarella-Branger
authors.forename: Jacky
authors.initials: J
authors.lastname: Palmari
authors.forename: D
authors.initials: D
authors.lastname: Braguer
authors.forename: Khe
authors.initials: K
authors.lastname: Hoang-Xuan
authors.forename: Karima
authors.initials: K
authors.lastname: Moktari
authors.forename: Jean-Claude C
authors.initials: JC
authors.lastname: Peragut
authors.forename: Pierre-Marie M
authors.initials: PM
authors.lastname: Martin
authors.forename: François
authors.initials: F
authors.lastname: Grisoli
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D018906:Antineoplastic Agents, Alkylating / Q000627:therapeutic use*; D001932:Brain Neoplasms / Q000175:diagnosis / Q000188:drug therapy*; D003606:Dacarbazine / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D005260:Female; D005909:Glioblastoma / Q000175:diagnosis / Q000188:drug therapy*; D006801:Humans; D008297:Male; D011379:Prognosis; D015996:Survival Rate; D000077204:Temozolomide; D016896:Treatment Outcome
chemical_list: D018906:Antineoplastic Agents, Alkylating; D003606:Dacarbazine; D000077204:Temozolomide