title: Revised response criteria for polycythemia vera and essential thrombocythemia: an ELN and IWG-MRT consensus project.
abstract: 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.
authors.affiliation: Center for the Study of Myelofibrosis, Biotechnology Research Area, Istituto di Ricovero e Cura a Carattere Scientifico Policlinico S. Matteo Foundation, Pavia, Italy. barosig@smatteo.pv.it
authors.forename: Giovanni
authors.initials: G
authors.lastname: Barosi
authors.forename: Ruben
authors.initials: R
authors.lastname: Mesa
authors.forename: Guido
authors.initials: G
authors.lastname: Finazzi
authors.forename: Claire
authors.initials: C
authors.lastname: Harrison
authors.forename: Jean-Jacques
authors.initials: JJ
authors.lastname: Kiladjian
authors.forename: Eva
authors.initials: E
authors.lastname: Lengfelder
authors.forename: Mary F
authors.initials: MF
authors.lastname: McMullin
authors.forename: Francesco
authors.initials: F
authors.lastname: Passamonti
authors.forename: Alessandro M
authors.initials: AM
authors.lastname: Vannucchi
authors.forename: Carlos
authors.initials: C
authors.lastname: Besses
authors.forename: Heinz
authors.initials: H
authors.lastname: Gisslinger
authors.forename: Jan
authors.initials: J
authors.lastname: Samuelsson
authors.forename: Srdan
authors.initials: S
authors.lastname: Verstovsek
authors.forename: Ronald
authors.initials: R
authors.lastname: Hoffman
authors.forename: Animesh
authors.initials: A
authors.lastname: Pardanani
authors.forename: Francisco
authors.initials: F
authors.lastname: Cervantes
authors.forename: Ayalew
authors.initials: A
authors.lastname: Tefferi
authors.forename: Tiziano
authors.initials: T
authors.lastname: Barbui
mesh_terms: D032921:Consensus; D006801:Humans; D007390:International Agencies / Q000592:standards*; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use*; D011087:Polycythemia Vera / Q000188:drug therapy* / Q000401:mortality; D017410:Practice Guidelines as Topic / Q000592:standards*; D012955:Societies, Medical; D013920:Thrombocythemia, Essential / Q000188:drug therapy* / Q000401:mortality
chemical_list: D010975:Platelet Aggregation Inhibitors