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SISTEMA NERVOSO
CENTRALE
Tiziana Falbo Oncologia Medica
I.N.I. - Grottaferrata ( RM )
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WHO 2016 Update : «Integrated diagnosis «
Histological Criteria & grade+ Molecular Markers
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Randomised phase III trial (CCTG CE.6-EORTC 26062-22061-TROG
08.02 )
Updated results of randomized phase II studies
• EORTC 1410 trial INTELLANCE 2
• REGOMA trial
Immunotherapy
• Checkpoint Inhibitors
New target and new subgroup in gliomas
High-Risk low grade gliomas: comparing RTOG and EORTC criteria
Pyrosequencing approach to detect MGMT methylation stat
TOPICS
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TREATMENT OPTIONS FOR ELDERLY (&FRAGILE?) PATIENTS
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CCTG CE.6 -EORTC 26062-22061
Study
Primary •Overall Survival
Secondary •PFS
•AEs
•Quality of life
•Translational studies
•MGMT Status
(Mandatory)
•Others planned
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CCTG CE.6 - EORTC 26062-22061 Overall Survival
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Overall Survival by MGMT status
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Overall survival combination arm :
improved survival
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REGOMA TRIAL
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REGOMA: STUDY DESIGN
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OBJECTIVES OF THE STUDY
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OS and PFS
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RESPONSE RATES AND SAFETY
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Immunotherapy checkpoint
inhibitors
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Overall Survival and Progression –free Survival
(Nivolumab vs Bevacizumab in recurrent GBM
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Response per investigator Assessment (RANO)
Nivolumab vs bevacizumab in recurrent GBM
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ADVANTAGES
• Feasible in FFPE specimens
• Yields quantitative results on
MGMT methylation status and
each CpG site methylation
• Reliable, reproducible, repeatable
• Overcome the problem of the
«gray zone»
OPEN ISSUES
• A cut-off value of MGMT methylation by pyrosequencing as basis for treatment decision in still unclear
• The relative clinical relevance of the methylation status of the individual CpGs have still to be determined
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Immunotherapy- vaccines
Coming soon …..
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Take-home messages
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Thanks for your attention!