恶性淋巴瘤疗效评价标准

Response Criteria for Lymphoma
Response Category CR
CRu
Physical Lymph
Examinatio Nodes
Nn ormal
Normal
Normal Normal
Normal Normal
PR
Normal Normal
Relapse/ progression
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
≥50%
decrease Decrease in ≥ 50%
liver/spleen decrease Enlarging New or
liver/spleen; increased
new sites
Lymph Node NMoarsmseasl Normal
> 75% decrease Normal
2. immunohistochemistry (IHC), 3. flow cytometry, 4. molecular biology
“REVISED RESPONSE CRITERIA FOR MALIGNANT LYMPHOMA”
J Clin Oncol 25:579-586. © 2007 by American Society of Clinical Oncology
First documentation of response
Time when new treatment is Entry onto trial needed
Death related to NHL
Death
Standardized response criteria provide uniform end points for clinical trials:
Failure or death from any cause
Entry onto trial
Disease progression or death Entry onto trial from NHL
Time to relapse
First documentation of response
Time to relapse or progression
“REVISED RESPONSE CRITERIA FOR MALIGNANT LYMPHOMA”
J Clin Oncol 2百度文库:579-586. © 2007 by American Society of Clinical Oncology
Cheson et al, J Clin Oncol 17:1244, 1999
Use of Positron Emission Tomography for Response Assessment of Lymphoma: Consensus of the Imaging Subcommittee of International Harmonization Project
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
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),
In 1999, 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
Progression-free survival
Disease-free survival
All patients CR, CRu
• 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.
≥50% decrease ≥50% decrease New or increased
Bone Marrow Normal
Indetermina Nteormal or indetermina Pteositive Irrelevant
Irrelevant
Reappearan ce
Definitions of End Points for Clinical Trials