Phase II study of two-weekly temozolomide in patients with high-grade gliomas

J Clin Neurosci. 2006 Jan;13(1):18-22. doi: 10.1016/j.jocn.2004.10.018. Epub 2005 Dec 13.

Abstract

Palliative chemotherapy has an increasing role in the management of recurrent high-grade gliomas. Temozolomide is a well-tolerated agent that results in objective responses and stabilisation of disease. Theoretically, temozolomide may be more effective when given in a prolonged schedule rather than the standard 5 days-monthly schedule. This Phase II study examined the efficacy and toxicity of temozolomide when given in a two-weekly schedule. Twenty-five patients received 150 mg/m2 temozolomide daily for seven days alternating with seven days of no treatment. One cycle of temozolomide was a total of two weeks treatment in every 28 days. Of the 25 evaluable patients, there was one complete response (4%), four partial responses (16%) and 10 patients had disease stablisation (40%). The progression free survival at 6 months was 56%. Two-weekly temozolomide was well tolerated with only four episodes of Grade 3 thrombocytopenia. Overall, two-weekly temozolomide is an active and well tolerated schedule, but does not appear to improve on the activity of temozolomide using the standard 5-day schedule.

Publication types

  • Clinical Trial, Phase II
  • Comparative Study
  • Multicenter Study

MeSH terms

  • Adult
  • Aged
  • Antineoplastic Agents, Alkylating / therapeutic use*
  • Dacarbazine / analogs & derivatives*
  • Dacarbazine / therapeutic use
  • Dose-Response Relationship, Drug
  • Drug Administration Schedule
  • Drug Evaluation
  • Female
  • Glioma / classification
  • Glioma / drug therapy*
  • Humans
  • Male
  • Middle Aged
  • Temozolomide
  • Time Factors
  • Treatment Outcome

Substances

  • Antineoplastic Agents, Alkylating
  • Dacarbazine
  • Temozolomide