Second International workshop on Interim-PET in Lymphoma April 8th-9th Menton (France)
Is Time for a European PET-response adapted protocol for DLBCL?
Dr. Umberto Vitolo SC Ematologia 2 AOU San Giovanni Battista Torino
Early clinical trials of interim PET in lymphoma in patients treated mainly without Rituximab PET after 4th cycle
PET after 1st cycle
Interim-PET + Spaepen et al, Ann Oncol 13: 1356, 2002
PET after 3rd cycle
Kostakoglu et al, Cancer 107: 2678, 2006
PET after 2nd cycle PPV 50 % NPV 74 % Accuracy 68.5%
Mikhaeel et al, Ann Oncol 16: 1514, 2005
Haioun et al, Blood 106: 1376, 2005
Issues for Interim PET in DLBCL
A “new” prognostic tool should be reassessed into the Rituximab era. Many prognostic factors have lost predictive value with the addition of Rituximab (TMA, bcl2 etc) Is early response identified by PET always associated with different PFS in DLBCL? Are interim PET results able to separate patients with a large difference in the outcome that can justify a change of the treatment? Is early change in the first-line treatment in PET+ patients associated with a better outcome compared to salvage therapy? PET negative patients may benefit from a reduction of the treatment?
INTERIM 18-FDG-POSITRON EMISSION TOMOGRAPHY/COMPUTED TOMOGRAPHY (PET) FAILED TO PREDICT DIFFERENT OUTCOME IN DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL) PATIENTS TREATED WITH R-CHOP April 2004 - December 2008: 82 newly diagnosed DLBCL or FL IIIb
All patients were treated according to the planned treatment without modification by Interim PET results: 6-8 R-CHOP14 in young poor prognosis patients according to IPI score: intermediate-high (IH) or high risk (H) 6-8 R-CHOP21 in all elderly or young good prognosis patients according to IPI score: low (L) or lowintermediate risk (LI) IF-RT consolidation to bulky lesions or bone lesions Pregno P, ASH 2009
CLINICAL CHARACTERISTICS (82 patients) Median age 56 years (range 22-81) Gender
38 interim scans Agreement complete: 68% by ECOG criteria 71% by London criteria Range of PET interim scans: 16% - 34% (p ns) by reviewer.
Moderate reproducibility among nuclear medicine experts Need to standardize PET interpretation in research and practice. Horning S, Blood 2010
Interim PET interpretation: possible pitfalls A negative interim PET is consistently associated with a good outcome Possible reasons for low PPV of Interim PET Interim biopsies show degree of inflammation or necrosis that may cause FDG uptake Immunotherapy may increase lesion inflammation (C activation, ADCC) and FDG uptake Different induction regimens may have different effect (CHOP vs RCHOP; 14 day vs 21 day interval) Different timing of PET imaging relative to chemotherapy (1-2 weeks after chemo in interim PET, 1 month after chemo in final PET) Different criteria for PET positive among studies Wide differences among observer and reviewers
Interim PET interpretation ….Until criteria for interpretation of PET scans are prospectively validated, and the experts can routinely agree on what is PET positive and what is PET negative, physicians should not change therapy for lymphoma based on an interim PET in practice, and probably should not even routinely perform such scans…. Friedberg JW, Blood 2010
PPV ranged from 20-30% to 50% among various studies. A treatment change on this basis means that 50-70% of the patients can be overtreated Different criteria may be necessary whether the endpoint is descalation (proper identification of negative patients) or intensification (proper identification of positive patients) of the treatment We need definitive and careful guidelines validated in a homogenous cohort of DLBCL patients treated with R-CHOP before tailoring therapy on interim-PET results
Ancillary trial 18-FDG-PET in IIL-DLCL04 Staging CT scan and 18-FDG-PET R-CHOP14/R-MegaCHOP14 X 2 Early response evaluation 18-FDG-PET R-CHOP14/R-MegaCHOP14 X 2 RESPONSE EVALUATION
Interim response evaluation by CT scan
R-MADx 2
R-CHOP14/RMegaCHOP14
18-FDG-PET pre ASCT BEAM-ASCT
NO CHANGE OF TREATMENT BASED ON EARLY 18-FDGPET RESULTS
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