Sagopilone (ZK-EPO, ZK 219477) for recurrent glioblastoma. A phase II multicenter trial by the European Organisation for Research and Treatment of Cancer (EORTC) Brain Tumor Group

R. Stupp*, A. Tosoni, J. E C Bromberg, P. Hau, M. Campone, J. Gijtenbeek, M. Frenay, L. Breimer, H. Wiesinger, A. Allgeier, M. J. van den Bent, U. Bogdahn, W. van der Graaf, H. J. Yun, T. Gorlia, D. Lacombe, A. A. Brandes

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

28 Scopus citations

Abstract

Background: Sagopilone (ZK 219477), a lipophylic and synthetic analog of epothilone B, that crosses the blood-brain barrier has demonstrated preclinical activity in glioma models. Patients and methods: Patients with first recurrence/progression of glioblastoma were eligible for this early phase II and pharmacokinetic study exploring single-agent sagopilone (16 mg/m2 over 3 h every 21 days). Primary end point was a composite of either tumor response or being alive and progression free at 6 months. Overall survival, toxicity and safety and pharmacokinetics were secondary end points. Results: Thirty-eight (evaluable 37) patients were included. Treatment was well tolerated, and neuropathy occurred in 46% patients [mild (grade 1): 32%]. No objective responses were seen. The progression-free survival (PFS) rate at 6 months was 6.7% [95% confidence interval (CI) 1.3-18.7], the median PFS was just over 6 weeks, and the median overall survival was 7.6 months (95% CI 5.3-12.3), with a 1-year survival rate of 31.6% (95% CI 17.7-46.4). Maximum plasma concentrations were reached at the end of the 3-h infusion, with rapid declines within 30 min after termination. Conclusions: No evidence of relevant clinical antitumor activity against recurrent glioblastoma could be detected. Sagopilone was well tolerated, and moderate-to-severe peripheral neuropathy was observed in despite prolonged administration.

Original languageEnglish (US)
Pages (from-to)2144-2149
Number of pages6
JournalAnnals of Oncology
Volume22
Issue number9
DOIs
StatePublished - Sep 2011

Keywords

  • Chemotherapy
  • Glioblastoma
  • Phase II trial
  • Recurrent disease
  • Sagopilone

ASJC Scopus subject areas

  • Hematology
  • Oncology

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