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Blood, 14 May 2009, Vol. 113, No. 20, pp. 4829-4833.
Prepublished online as a Blood First Edition Paper on March 10, 2009; DOI 10.1182/blood-2008-09-176818.
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Submitted September 9, 2008
Accepted February 19, 2009
Response criteria for essential thrombocythemia and polycythemia vera: result of a European LeukemiaNet (ELN) consensus conference
Giovanni Barosi*, Gunnar Birgegard, Guido Finazzi, Martin Griesshammer, Claire Harrison, Hans Carl Hasselbalch, Jean-Jacques Kiladjian, Eva Lengfelder, Mary Frances McMullin, Francesco Passamonti, John T. Reilly, Alessandro M Vannucchi, and Tiziano Barbui
Unit of Clinical Epidemiology and Center for the Study of Myelofibrosis, IRCCS Policlinico S. Matteo Foundation, Pavia, Italy
Department of Haematology, University Hospital, Uppsala, Sweden
Division of Transfusion Medicine, Ospedali Riuniti di Bergamo, Bergamo, Italy
Department of Hematology and Oncology, Johannes Wesling Medical Centre Minden, Academic Hospital of the University of Hannover, Minden, Germany
Department of Haematology, Guy's and St Thomas' NHS Foundation Trust, London, United Kingdom
Department of Hematology, L. Herlev Hospital, University of Copenhagen, Copenhagen, Denmark
Assistance Publique - Hopitaux de Paris, Hopital Avicenne, Service d'Hematologie Clinique; Universite Paris 13, Bobigny, France
Department of Medicine III, Faculty for Medicine Mannheim, University of Heidelberg, Heidelberg, Germany
Centre for Cancer Research and Cell Biology, Queen's University, Belfast, United Kingdom
Divsion of Hematology, University of Pavia, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy
Molecular Haematology Unit, Division of Molecular and Genetic Medicine, Royal Hallamshire Hospital, Sheffiled, United Kingdom
Unita Funzionale di Ematologia, Dipartmento di Area Critica Medico-Chirurgica, Universita degli Studi, Firenze, Italy
Division of Hematology, Ospedali Riuniti di Bergamo, Bergamo, Italy
* Corresponding author; email: barosig{at}smatteo.pv.it.
European experts were convened to develop a definition of response to treatment in polycythemia vera (PV) and essential thrombocythemia (ET). Clinico-hematological (CH), molecular and histological response categories were selected. In ET, CH complete response (CR) was: platelet count  400 x109/L, no disease related symptoms, normal spleen size, and WBC count 10 x 109/L. Platelet count 600 x109/L or a decrease greater than 50% was partial response (PR). In PV, CH-CR was: hematocrit <45% without phlebotomy, platelet count 400 x109/L, WBC count 10 x 109/L, and no disease related symptoms. A hematocrit <45% without phlebotomy, or response in three or more of the other criteria was defined as PR. In both ET and in PV, molecular CR was a reduction of any molecular abnormality to undetectable levels. Molecular PR was defined as a reduction  50% in patients with <50% mutant allele burden, or a reduction 25% in patients with >50% mutant allele burden. Bone marrow histological response in ET was judged on megakaryocyte hyperplasia, while on cellularity and reticulin fibrosis in PV. The combined use of these response definitions should help standardize the design and reporting of clinical studies.
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