Stupp, Roger and Tosoni, A. and Bromberg, J. E. C. and Hau, P. and Campone, M. and Gijtenbeek, J. and Frenay, M. and Breimer, L. and Wiesinger, H. and Allgeier, A. and van den Bent, M. J. and Bogdahn, U. and van der Graaf, W. and Yun, H. J. and Gorlia, T. and Lacombe, D. and Brandes, A. A. (2011) 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. ANNALS OF ONCOLOGY, 22 (9). pp. 2144-2149. ISSN 0923-7534,
Full text not available from this repository. (Request a copy)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/m(2) 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.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | FULLY SYNTHETIC EPOTHILONE; BEVACIZUMAB PLUS IRINOTECAN; MALIGNANT GLIOMA; SOLID TUMORS; MULTIFORME; TEMOZOLOMIDE; RADIOTHERAPY; SURVIVAL; chemotherapy; glioblastoma; phase II trial; recurrent disease; sagopilone |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Neurologie |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 02 Jun 2020 08:45 |
| Last Modified: | 02 Jun 2020 08:45 |
| URI: | https://pred.uni-regensburg.de/id/eprint/20317 |
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