• • • • • Response Criteria End Points for Clinical Trials Imaging Clinical Features Pathology/Biology
Use of Positron Emission Tomography for Response Assessment of Lymphoma: Consensus of the Imaging Subcommittee of International Harmonization Project in Lymphoma
• Allowing for comparisons among studies
• Facilitating the identification of more effective therapies
The widely used IWG criteria for response assessment of lymphoma are based predominantly on CT.
It became clear that the International Working Group criteria warranted revision, because of identified limitations and the increased use of :
1. [18F] fluorodeoxyglucose-positron emission tomography (PET), 2. immunohistochemistry (IHC), 3. flow cytometry, 4. molecular biology
“REVISED RESPONSE CRITERIA FOR MALIGNANT LYMPHOMA”
J Clin Oncol 25:579-586. © 2019 by American Society of Clinical Oncology
The Competence Network Malignant Lymphoma convened an International Harmonization Project at which 5 subcommittees were fora for Lymphoma
Response Category
CR CRu
Physical Examination
Normal Normal Normal
Lymph Nodes Lymph Node Masses
Normal Normal Normal Normal Normal > 75% decrease
≥50% decrease ≥50% decrease New or increased
Positive
Irrelevant Irrelevant Reappearance
Relapse/ progression
Enlarging liver/spleen; new sites
Definitions of End Points for Clinical Trials
Bone Marrow
Normal Indeterminate Normal or indeterminate
PR
Normal
Normal Decrease in liver/spleen
Normal
≥50% decrease ≥ 50% decrease New or increased
Normal
Time to next treatment Cause-specific death
All patients
All patients
Death
Standardized response criteria provide uniform end points for clinical trials:
Progression-free survival Disease-free survival Response duration
All patients CR, CRu CR, CRu, PR
Entry onto trial First documentation of response First documentation of response Entry onto trial
“REVISED RESPONSE CRITERIA FOR MALIGNANT LYMPHOMA”
J Clin Oncol 25:579-586. © 2019 by American Society of Clinical Oncology
Cheson et al, J Clin Oncol 17:1244, 2019 In 2019, an International Working Group (IWG) of clinicians, radiologists, and pathologists with expertise in the evaluation and management of patients with Lymphoma published guidelines for response assessment and outcomes measurement.
End Point Overall survival Event-free survival Response Category All patients CR, CRu, PR Definition Death from any cause Failure or death from any cause Disease progression or death from NHL Time to relapse Time to relapse or progression Time when new treatment is needed Death related to NHL Point of Measurement Entry onto trial Entry onto trial