title: A randomized phase III study: comparison between intravenous and intraarterial ACNU administration in newly diagnosed primary glioblastomas.
abstract: BACKGROUND
  In this randomized phase III study, the effectiveness as well as the side-effects of intraarterial [i.a.] (17 patients) versus intravenous [i.v.] (16 patients) ACNU [Nimustine] administration in newly diagnosed glioblastoma, were compared.
  
  
  METHODS
  All patients undenwent extensive surgical resection, and both groups were homogeneous for the other known risk factors. Thirty-three patients with glioblastoma were treated with ACNU at the dose of 80-100 mg/m2. Treatment was repeated every 5-8 weeks for a minimum of 2 and maximum of 14 cycles. Total survival time (TST) and to time to progression were chosen as outcome variables.
  
  
  CONCLUSIONS
  No significant differences in systemic and hematological toxicity between the i.a. and iv. ACNU administration routes were detected. In both groups, tolerance of the procedure was excellent. Analysis of the main outcome measured showed no significant differences between i.a. and i.v. ACNU administration: time to progression was 6 months for i.a. ACNU and 4 months for i.v. ACNU and total survival time was 17 months for i.a. ACNU and 20 months for i.v. ACNU. In spite of ACNU dose incrementation, obtained through i.a. route administration, and subsequent higher concentration in the tumor bed, no improvement could be achieved in effectiveness.
authors.affiliation: Department of Neurology, Policlinico di Monza, Italy.
authors.forename: F
authors.initials: F
authors.lastname: Imbesi
authors.forename: E
authors.initials: E
authors.lastname: Marchioni
authors.forename: E
authors.initials: E
authors.lastname: Benericetti
authors.forename: F
authors.initials: F
authors.lastname: Zappoli
authors.forename: A
authors.initials: A
authors.lastname: Galli
authors.forename: M
authors.initials: M
authors.lastname: Corato
authors.forename: M
authors.initials: M
authors.lastname: Ceroni
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D005909:Glioblastoma / Q000188:drug therapy*; D006801:Humans; D007261:Infusions, Intra-Arterial; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D009422:Nervous System Diseases / Q000139:chemically induced; D015376:Nimustine / Q000008:administration & dosage* / Q000009:adverse effects; D015173:Supratentorial Neoplasms / Q000188:drug therapy*
chemical_list: D000970:Antineoplastic Agents; D015376:Nimustine