title: Phase II study of first-line chemotherapy with temozolomide in recurrent oligodendroglial tumors: the European Organization for Research and Treatment of Cancer Brain Tumor Group Study 26971.
abstract: OBJECTIVE
  Oligodendroglial tumors are chemotherapy-sensitive tumors, with two thirds of patients responding to combination chemotherapy with procarbazine, lomustine, and vincristine (PCV). Temozolomide (TMZ), a new alkylating and methylating agent, has demonstrated high response rates in patients with recurrent anaplastic astrocytoma. We investigated TMZ as first-line chemotherapy in recurrent oligodendroglial tumors (OD) and mixed oligoastrocytomas (OA) after surgery and radiation therapy.
  
  
  METHODS
  In a prospective, nonrandomized, multicenter, phase II trial, patients were treated with 200 mg/m2 of TMZ on days 1 through 5 in 28-day cycles for 12 cycles. Patients with a recurrence after prior surgery and radiotherapy, and with measurable and enhancing disease on magnetic resonance imaging (MRI) were eligible for this study. Patients with large lesions and mass effect or with new clinical deficits were not eligible. Pathology and the MRI scans of all responding patients were centrally reviewed.
  
  
  RESULTS
  Thirty-eight eligible patients were included. In three patients, pathology review did not confirm the presence of an OD or OA. TMZ was generally well tolerated. The most frequent side effects were hematologic; only one patient discontinued treatment for toxicity. In 20 (52.6%) of 38 patients (95% exact confidence interval, 35.8% to 69.0%), a complete (n = 10) or partial response to TMZ was observed. The median time to progression was 10.4 months for all patients and 13.2 months for responding patients. At 12 months from the start of treatment, 40% of patients were still free from progression.
  
  
  CONCLUSIONS
  TMZ provides an excellent response rate with good tolerability in chemotherapy-naive patients with recurrent OD. A randomized phase III study comparing PCV with TMZ is warranted.
authors.affiliation: Department of Neuro-Oncology, University Hospital Rotterdam/Rotterdam Cancer Center, the Netherlands. m.vandenbent@erasmusmc.nl
authors.forename: M J
authors.initials: MJ
authors.lastname: van den Bent
authors.forename: M J B
authors.initials: MJ
authors.lastname: Taphoorn
authors.forename: A A
authors.initials: AA
authors.lastname: Brandes
authors.forename: J
authors.initials: J
authors.lastname: Menten
authors.forename: R
authors.initials: R
authors.lastname: Stupp
authors.forename: M
authors.initials: M
authors.lastname: Frenay
authors.forename: O
authors.initials: O
authors.lastname: Chinot
authors.forename: J M
authors.initials: JM
authors.lastname: Kros
authors.forename: C C D
authors.initials: CC
authors.lastname: van der Rijt
authors.forename: Ch J
authors.initials: ChJ
authors.lastname: Vecht
authors.forename: A
authors.initials: A
authors.lastname: Allgeier
authors.forename: T
authors.initials: T
authors.lastname: Gorlia
mesh_terms: D000328:Adult; D018906:Antineoplastic Agents, Alkylating / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D001932:Brain Neoplasms / Q000188:drug therapy* / Q000473:pathology; D003606:Dacarbazine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000494:pharmacology*; D018450:Disease Progression; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D009837:Oligodendroglioma / Q000188:drug therapy* / Q000473:pathology; D000077204:Temozolomide; D016896:Treatment Outcome
chemical_list: D018906:Antineoplastic Agents, Alkylating; D003606:Dacarbazine; D000077204:Temozolomide