当前位置:文档之家› 恶性淋巴瘤疗效评价标准共27页

恶性淋巴瘤疗效评价标准共27页


Response Criteria for Lymphoma
Response Category CR CRu
PR
Relapse/ progression
Physical Examination
Normal
Lymph Nodes Lymph Node Masses
Normal
Normal
Bone Marrow Normal
Failure or death from any Entry onto trial cause
Disease progression or death from NHL Time to relapse
Time to relapse or progression
Entry onto trial
First documentation of response First documentation of response
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),
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.
Lymphoma
J Clin Oncol 25:571-578. © 2019 by American Society of Clinical Oncology
• 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.
The Competence Network Malignant Lymphoma convened an International
Harmonization Project at which 5 subcommittees were formed:
• Response Criteria • End Points for Clinical Trials • Imaging • Clinical Features • Pathology/Biology
> 75% decrease
Normal
≥50% decrease
≥50% decrease
New or increased
Normal or indeterminate Positive Irrelevant
Irrelevant
Reappearance
Definitions of End Points for Clinical Trials
Response duration CR, CRu, PR
Time to next treatment
All patients
Cause-specific death All patients
Definition Death from any cause
Point of Measurement
Entry onto trial
Normal
Normal
Normal
Indeterminate
Normal
Normal
Normal
Normal
Decrease in liver/spleen Enlarging liver/spleen; new sites
Normal
≥50% decrease ≥ 50% decrease
New or increased
Time when new treatment Entry onto trial is needed
Death related to NHL
Death
Standardized response criteria provide uniform end points for
clinical trials:
Use of Positron Emission Tomography for Response Assessment of Lymphoma: Consensus of the Imaging Subcommittee of International Harmonization Project in
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

End Point Overall survival
Response Category
All patients
Event-free survival CR, CRu, PR
Progression-free survival
Disease-free survival
All patients CR, CRu
相关主题