Revised response criteria for malignant lymphoma.
OBJECTIVE
Standardized response criteria are needed to interpret and compare clinical trials and for approval of new therapeutic agents by regulatory agencies.


METHODS
The International Working Group response criteria (Cheson et al, J Clin Oncol 17:1244, 1999) were widely adopted, but required reassessment because of identified limitations and the increased use of [18F]fluorodeoxyglucose-positron emission tomography (PET), immunohistochemistry (IHC), and flow cytometry. The International Harmonization Project was convened to provide updated recommendations.


RESULTS
New guidelines are presented incorporating PET, IHC, and flow cytometry for definitions of response in non-Hodgkin's and Hodgkin's lymphoma. Standardized definitions of end points are provided.


CONCLUSIONS
We hope that these guidelines will be adopted widely by study groups, pharmaceutical and biotechnology companies, and regulatory agencies to facilitate the development of new and more effective therapies to improve the outcome of patients with lymphoma.
Cheson
Bruce D
BD
Division of Hematology/Oncology, Georgetown University Hospital, Washington, DC, USA. bdc4@georgetown.edu
Pfistner
Beate
B
Juweid
Malik E
ME
Gascoyne
Randy D
RD
Specht
Lena
L
Horning
Sandra J
SJ
Coiffier
Bertrand
B
Fisher
Richard I
RI
Hagenbeek
Anton
A
Zucca
Emanuele
E
Rosen
Steven T
ST
Stroobants
Sigrid
S
Lister
T Andrew
TA
Hoppe
Richard T
RT
Dreyling
Martin
M
Tobinai
Kensei
K
Vose
Julie M
JM
Connors
Joseph M
JM
Federico
Massimo
M
Diehl
Volker
V
D002986:Clinical Trials as Topic / Q000379:methods / Q000592:standards*; D023381:Endpoint Determination / Q000592:standards; D005434:Flow Cytometry / Q000592:standards; D019788:Fluorodeoxyglucose F18; D006689:Hodgkin Disease / Q000000981:diagnostic imaging / Q000473:pathology* / Q000628:therapy*; D006801:Humans; D007090:Image Interpretation, Computer-Assisted; D007150:Immunohistochemistry / Q000592:standards; D008228:Lymphoma, Non-Hodgkin / Q000000981:diagnostic imaging / Q000473:pathology* / Q000628:therapy*; D049268:Positron-Emission Tomography / Q000592:standards; D019275:Radiopharmaceuticals; D016019:Survival Analysis; D009626:Terminology as Topic; D013997:Time Factors; D014057:Tomography, X-Ray Computed / Q000592:standards; D016896:Treatment Outcome
D019275:Radiopharmaceuticals; D019788:Fluorodeoxyglucose F18