Appropriate end-points for right results in the age of antiangiogenic agents: Future options for phase II trials in patients with recurrent glioblastoma.

Details

Serval ID
serval:BIB_39B701424A31
Type
Article: article from journal or magazin.
Publication sub-type
Review (review): journal as complete as possible of one specific subject, written based on exhaustive analyses from published work.
Collection
Publications
Institution
Title
Appropriate end-points for right results in the age of antiangiogenic agents: Future options for phase II trials in patients with recurrent glioblastoma.
Journal
European Journal of Cancer (oxford, England : 1990)
Author(s)
Brandes A.A., Franceschi E., Gorlia T., Wick W., Jacobs A.H., Baumert B.G., van den Bent M., Weller M., Stupp R., On behalf of European Organisation for Research
Working group(s)
Treatment of Cancer Brain Tumour Group
ISSN
1879-0852 (Electronic)
ISSN-L
0959-8049
Publication state
Published
Issued date
2012
Peer-reviewed
Oui
Volume
48
Number
6
Pages
896-903
Language
english
Notes
Publication types: JOURNAL ARTICLE
Abstract
The progression-free survival rate at 6months (PFS-6) has long been considered the best end-point for assessing the efficacy of new agents in phase II trials in patients with recurrent glioblastoma. However, due to the introduction of antiangiogenic agents in this setting, and their intrinsic propensity to alter neuroradiological disease assessment by producing pseudoregression, any end-point based on neuroradiological modifications should be reconsidered. Further, statistically significant effects on progression-free survival (PFS) only should not automatically be considered reliable evidence of meaningful clinical benefit. In this context, because of its direct and unquestionable clinical relevance, overall survival (OS) represents the gold standard end-point for measuring clinical efficacy, despite the disadvantage that it is influenced by subsequent therapies and usually takes longer time to be evaluated. Therefore, while awaiting novel imaging criteria for response evaluation and/or new imaging tools to distinguish between 'true' and 'pseudo'-responses to antiangiogenic agents, the measurement of OS or OS rates should be considered primary end-points, also in phase II trials with these agents.
Pubmed
Web of science
Create date
28/04/2012 8:35
Last modification date
20/08/2019 13:29
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