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

Autor: H. Wiesinger, Ulrich Bogdahn, Jacoline E C Bromberg, Alicia Tosoni, J.M.M. Gijtenbeek, Peter Hau, W.T.A. van der Graaf, Anouk Allgeier, Denis Lacombe, Marc Frenay, Mario Campone, Alba A. Brandes, Roger Stupp, Hwan Jung Yun, M. J. van den Bent, L. Breimer, Thierry Gorlia
Přispěvatelé: Neurology
Jazyk: angličtina
Rok vydání: 2017
Předmět:
Male
Oncology
recurrent disease
medicine.medical_treatment
Brain Tumors
Neuroinformatics [DCN 3]
chemotherapy
0302 clinical medicine
phase II trial
Infusions
Intravenous
0303 health sciences
Brain Neoplasms
Hematology
Middle Aged
3. Good health
030220 oncology & carcinogenesis
Disease Progression
Female
Adult
medicine.medical_specialty
Antineoplastic Agents
Astrocytoma
Disease-Free Survival
Young Adult
03 medical and health sciences
SDG 3 - Good Health and Well-being
Translational research [ONCOL 3]
Multicenter trial
Internal medicine
Glioma
medicine
Humans
Benzothiazoles
Progression-free survival
Survival rate
sagopilone
Aged
030304 developmental biology
Chemotherapy
Surrogate endpoint
business.industry
glioblastoma
Cancer
Original Articles
medicine.disease
Surgery
Peripheral neuropathy
Epothilones
Neoplasm Recurrence
Local
business
Zdroj: Annals of Oncology, 22, 2144-9
Annals of Oncology, 22, 9, pp. 2144-9
Annals of Oncology, vol. 22, no. 9, pp. 2144-2149
Annals of Oncology
Annals of Oncology, 22(9), 2144-2149. Elsevier Ltd.
ISSN: 0923-7534
Popis: Item does not contain fulltext 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. 01 september 2011
Databáze: OpenAIRE
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