Temozolomide as a second-line systemic regimen in recurrent high-grade glioma: A phase II study

A. A. Brandes, M. Ermani, U. Basso, P. Amistà, F. Berti, R. Scienza, A. Rotilio, G. Pinna, M. Gardiman, S. Monfardini

Research output: Contribution to journalArticlepeer-review


Background: To investigate the efficacy of temozolomide in relation to response rate, toxicity, time to progression, and median survival time, a phase II study was conducted in patients with recurrent high-grade glioma following surgery plus radiotherapy and first-line chemotherapy based on nitrosourea, procarbazine and vincristine. Patients and methods: Forty-one patients with high-grade glioma, at second recurrence or progression, of which twenty-two (54%) had glioblastoma multiforme, ten (24%) anaplastic astrocytoma, and nine (22%) anaplastic oligodendroglioma were administered temozolomide, 150 mg/m2/daily for five days every four weeks. Results: Response was assessed in 40 patients. The overall response rate (complete + partial response) was 22.5% (95% confidence interval (CI): 9.5%-35%). The median time to progression for all 41 patients was 22.3 weeks; progression-free survival at 6 and 12 months was 48.5% and 34.7%, respectively. Median survival time was 37.1 weeks with 80.2% at 6 and 34.9% survival at 12 months. Conclusions: On multivariate analysis, response to previous treatment was significant (P = 0.03) for time to progression and Karnofsky performance score for overall survival (P = 0.002). Temozolomide gave a moderate response rate with acceptable toxicity as second-line chemotherapy in patients with recurrent high-grade glioma.

Original languageEnglish
Pages (from-to)255-257
Number of pages3
JournalAnnals of Oncology
Issue number2
Publication statusPublished - 2001


  • Brain tumours
  • Chemotherapy
  • Recurrent
  • Temozolomide

ASJC Scopus subject areas

  • Oncology
  • Cancer Research


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