HIGH TUMOR BURDEN FOLLICULAR LYMPHOMA IMPACT OF [18F]-FDG POSITRON EMISSION TOMOGRAPHY (PET) IN THE ASSESSMENT OF TREATMENT RESPONSE NCT00915096
Principal investigator: Michel Meignan (GELA) Principal investigator: Jehan Dupuis (GELA)
Rationale • FDG uptake in 95% of FL whatever the histological grade. Weiler-Sagie, J Nucl Med 2010
• PET could identify the site of transformation. Bodet-Milin, Haematologica 2008
• PET prognostic value (interim & end-treatment) should be prospectively evaluated in the context of new immuno chemotherapy regimens
PET after 3 CHOP-R is predicting of PFS PET-
PET+
Prospective study 60 patients untreated by Chemo or R (advanced stage FL) 3 CHOP-R + 90Y RIT + 4 R Median follow up: 19.7months Jacobs, Swerdlow, Clin Cancer Res 2008
Main purpose of the study NCT00915096
To assess in a prospective series of 120 patients with high tumor burden follicular lymphoma treated with R-CHOP, the predictive value of 18FDG PET performed over (after 4 cycles), and at the end of first-line treatment on progressionfree survival at 2 years.
Inclusion criteria
• Patients aged 18-80 years • Follicular lymphoma, histological grade 1-3 • Not previously treated
• With at least one of the GELF criteria
CHOP - R
CHOP - R
CHOP - R
CHOP - R
CHOP - R
CHOP - R
R
R
Protocol timeline
0
3
6
9
12
15
18
21
PET 0
PET 4
24
27
30 PET 8
FOLLICULAR LYMPHOMA 03/24/2010
Accrual curve (8/2007 to 11/2009): 120 patients included
14 centers (13 french, one italian)
7
Preliminary analysis
• 60 first patients having completed PET8 • Limited to PET analysis, inclusion criteria and FLIPI • Read only by one expert but on the same workstation (5PS) • No follow-up analysis
Patients characteristics (60 patients) Age 7cm) alone 3 nodes > 3cm Bulky + 3 nodes No Bulky/no 3 nodes
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