TY - JOUR
T1 - Revised response criteria for polycythemia vera and essential thrombocythemia
T2 - An ELN and IWG-MRT consensus project
AU - Barosi, Giovanni
AU - Mesa, Ruben
AU - Finazzi, Guido
AU - Harrison, Claire
AU - Kiladjian, Jean Jacques
AU - Lengfelder, Eva
AU - McMullin, Mary F.
AU - Passamonti, Francesco
AU - Vannucchi, Alessandro M.
AU - Besses, Carlos
AU - Gisslinger, Heinz
AU - Samuelsson, Jan
AU - Verstovsek, Srdan
AU - Hoffman, Ronald
AU - Pardanani, Animesh
AU - Cervantes, Francisco
AU - Tefferi, Ayalew
AU - Barbui, Tiziano
N1 - Publisher Copyright:
© 2013 by The American Society of Hematology.
PY - 2013/6/6
Y1 - 2013/6/6
N2 - Standardized response criteria to interpret and compare clinical trials are needed for approval of new therapeutic agents by regulatory agencies. The European LeukemiaNet (ELN) response criteria for essential thrombocythemia (ET) and polycythemia vera (PV) issued in 2009 have been widely adopted as end points in a number of recent clinical trials. However, evidence exists that they do not predict response or provide clinically relevant measures of benefit for the patients. This article presents revised recommendations for assessing response in ET and PV provided by a working group established by ELN and International Working Group-Myeloproliferative Neoplasms Research and Treatment. New definitions of complete and partial remission incorporate clinical, hematological, and histological response assessments that include a standardized symptom assessment form and consider absence of disease progression and vascular events. We anticipate that these criteria will be adopted widely to facilitate the development of new and more effective therapies for ET and PV.
AB - Standardized response criteria to interpret and compare clinical trials are needed for approval of new therapeutic agents by regulatory agencies. The European LeukemiaNet (ELN) response criteria for essential thrombocythemia (ET) and polycythemia vera (PV) issued in 2009 have been widely adopted as end points in a number of recent clinical trials. However, evidence exists that they do not predict response or provide clinically relevant measures of benefit for the patients. This article presents revised recommendations for assessing response in ET and PV provided by a working group established by ELN and International Working Group-Myeloproliferative Neoplasms Research and Treatment. New definitions of complete and partial remission incorporate clinical, hematological, and histological response assessments that include a standardized symptom assessment form and consider absence of disease progression and vascular events. We anticipate that these criteria will be adopted widely to facilitate the development of new and more effective therapies for ET and PV.
UR - http://www.scopus.com/inward/record.url?scp=84881065384&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84881065384&partnerID=8YFLogxK
U2 - 10.1182/blood-2013-01-478891
DO - 10.1182/blood-2013-01-478891
M3 - Article
C2 - 23591792
AN - SCOPUS:84881065384
SN - 0006-4971
VL - 121
SP - 4778
EP - 4781
JO - Blood
JF - Blood
IS - 23
ER -