title: Phase II study of ifosfamide, carboplatin, and etoposide in patients with a first recurrence of glioblastoma multiforme.
abstract: OBJECTIVE
  The prognosis of recurrent glioblastoma multiforme (GBM) remains unsatisfactory. The authors conducted a Phase II study of ifosfamide, carboplatin, and etoposide (ICE) for a first recurrence of GBM to determine whether it prolonged a patient's good-quality life.
  
  
  METHODS
  This trial was an open-label, single-center Phase II study. Forty-two patients with a first GBM relapse after surgery followed by standard radiotherapy (60 Gy) and first-line temozolomide- or nimustine-based chemotherapy were eligible to participate. The primary end point was progression-free survival at 6 months after the ICE treatment (PFS-6), and secondary end points were response rate, toxicity, and overall survival. Chemotherapy consisted of ifosfamide (1000 mg/m(2) on Days 1, 2, and 3), carboplatin (110 mg/m(2) on Day 1), etoposide (100 mg/m(2) on Days 1, 2, and 3), every 6 weeks.
  
  
  RESULTS
  Progression-free survival at 6 months after ICE treatment was 35% (95% CI 22-50%). The median duration of PFS was 17 weeks (95% CI 10-24 weeks). The response rate was 25% (95% CI 9-34%). Adverse events were generally mild and consisted mainly of alopecia.
  
  
  CONCLUSIONS
  This regimen was well tolerated and has some activity and could be one of the options for patients with recurrent GBM.
authors.affiliation: Department of Neurosurgery, Kitano Hospital Medical Research Institute, Osaka, Japan. tomokazu@kitano-hp.or.jp
authors.forename: Tomokazu
authors.initials: T
authors.lastname: Aoki
authors.forename: Tomohiko
authors.initials: T
authors.lastname: Mizutani
authors.forename: Kuniharu
authors.initials: K
authors.lastname: Nojima
authors.forename: Takehisa
authors.initials: T
authors.lastname: Takagi
authors.forename: Ryosuke
authors.initials: R
authors.lastname: Okumura
authors.forename: Yoshiaki
authors.initials: Y
authors.lastname: Yuba
authors.forename: Tetsuya
authors.initials: T
authors.lastname: Ueba
authors.forename: Jun A
authors.initials: JA
authors.lastname: Takahashi
authors.forename: Shin-Ichi
authors.initials: S
authors.lastname: Miyatake
authors.forename: Kazuhiko
authors.initials: K
authors.lastname: Nozaki
authors.forename: Waro
authors.initials: W
authors.lastname: Taki
authors.forename: Masao
authors.initials: M
authors.lastname: Matsutani
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols; D001932:Brain Neoplasms / Q000188:drug therapy*; D016190:Carboplatin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D018450:Disease Progression; D005047:Etoposide / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D005909:Glioblastoma / Q000188:drug therapy* / Q000628:therapy; D006801:Humans; D007069:Ifosfamide / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D011788:Quality of Life; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000970:Antineoplastic Agents; D005047:Etoposide; D016190:Carboplatin; D007069:Ifosfamide