Evaluation of pseudoprogression rates and tumor progression patterns in a phase III trial of bevacizumab plus radiotherapy/temozolomide for newly diagnosed glioblastoma
BackgroundEvaluation of glioblastoma disease status may be complicated by treatment-induced changes and discordance between enhancing and nonenhancing MRI. Exploratory analyses are presented (prospectively assessed pseudoprogression and therapy-related tumor pattern changes) from the AVAglio trial (...
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| Main Authors: | , |
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| Format: | Article (Journal) |
| Language: | English |
| Published: |
11 August 2016
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| In: |
Neuro-Oncology
Year: 2016, Volume: 18, Issue: 10, Pages: 1434-1441 |
| ISSN: | 1523-5866 |
| DOI: | 10.1093/neuonc/now091 |
| Online Access: | Verlag, kostenfrei, Volltext: http://dx.doi.org/10.1093/neuonc/now091 Verlag, kostenfrei, Volltext: https://academic.oup.com/neuro-oncology/article/18/10/1434/2223016 
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| Author Notes: | Wolfgang Wick, Olivier L. Chinot, Martin Bendszus, Warren Mason, Roger Henriksson, Frank Saran, Ryo Nishikawa, Cedric Revil, Yannick Kerloeguen, Timothy Cloughesy |
MARC
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| 245 | 1 | 0 | |a Evaluation of pseudoprogression rates and tumor progression patterns in a phase III trial of bevacizumab plus radiotherapy/temozolomide for newly diagnosed glioblastoma |c Wolfgang Wick, Olivier L. Chinot, Martin Bendszus, Warren Mason, Roger Henriksson, Frank Saran, Ryo Nishikawa, Cedric Revil, Yannick Kerloeguen, Timothy Cloughesy |
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| 520 | |a BackgroundEvaluation of glioblastoma disease status may be complicated by treatment-induced changes and discordance between enhancing and nonenhancing MRI. Exploratory analyses are presented (prospectively assessed pseudoprogression and therapy-related tumor pattern changes) from the AVAglio trial (bevacizumab or placebo plus radiotherapy/temozolomide for newly diagnosed glioblastoma).MethodsMRI was done every 8 weeks (beginning 4 wk after chemoradiotherapy) using prespecified and standardized T1 and T2 protocols. Progressive disease (PD) at 10 weeks was reconfirmed at 18 weeks to distinguish pseudoprogression. Progression-free survival (PFS), excluding cases of confirmed pseudoprogression, was assessed (post-hoc/exploratory). Tumor progression patterns were determined at each disease assessment/PD (prespecified/exploratory).ResultsOf patients with PD in the bevacizumab and placebo arms, 143/354 (40.4%) and 155/387 (40.1%), respectively, had PD due to contrast-enhancing lesions, and 51/354 (14.4%) and 53/387 (13.7%) had PD due to nonenhancing lesions. Of all patients in the bevacizumab arm (n = 458), 2.2% had confirmed pseudoprogression versus 9.3% in the placebo arm (n = 463). Baseline characteristics did not differ between patients with/without pseudoprogression (including for MGMT status). Excluding confirmed pseudoprogression, PFS (hazard ratio: 0.65, 95% CI: 0.56-0.75; P < .0001, bevacizumab vs placebo) was comparable to the intent-to-treat population. At PD, most patients had the same tumor focus (local/multifocal, >84%) and infiltrative profile (>88%) as at baseline; no shift to a diffuse or multifocal phenotype was observed.ConclusionsPseudoprogression complicated progression assessment in a small but relevant number of patients but had negligible impact on PFS. Bevacizumab did not appear to adversely impact tumor progression patterns. | ||
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