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Blood, 15 October 2005, Vol. 106, No. 8, pp. 2849-2853.
Prepublished online as a Blood First Edition Paper on June 30, 2005; DOI 10.1182/blood-2005-04-1520.
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NEOPLASIA
Response criteria for myelofibrosis with myeloid metaplasia: results of an initiative of the European Myelofibrosis Network (EUMNET)
Giovanni Barosi,
Dominique Bordessoule,
Jean Briere,
Francisco Cervantes,
Jean-Loup Demory,
Brigitte Dupriez,
Heinz Gisslinger,
Martin Griesshammer,
Hans Hasselbalch,
Rajko Kusec,
Marie-Caroline Le Bousse-Kerdiles,
Nicola L. Liberato,
Monia Marchetti,
John T. Reilly, and
Jurgen Thiele
From the Laboratory of Clinical Epidemiology, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Policlinico San Matteo, Pavia, Italy; Service d'Hématologie Clinique, Limoges, France; Department of Hematology, Hopital Beaujon, Clichy, France; Hematology Department, Hospital Clinic, L'Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain; Département d'Hématologie, Université Catholique de Lille, France; Service d'Hématologie Clinique, Centre Hospitalier de Lens, France; Department of Hematology and Blood Coagulation, University of Vienna, Austria; Department of Medicine III, Hematology, Oncology, Rheumatology and Infectious Diseases, University of Ulm, Germany; Department of Medicine, Division of Hematology and Oncology, Roskilde Hospital, Denmark; Institute of Clinical Chemistry and Department of Medicine, University Hospital Merkur, Zagreb, Croatia; Institut National de la Santé et de la Recherche Médicale (INSERM) U268, Institut André Lwoff, Hôpital Paul Brousse, Villejuif, France; Molecular Haematology Unit, Division of Molecular and Genetic Medicine, Royal Hallamshire Hospital, Sheffield, United Kingdom; and Institute of Pathology, University of Cologne, Germany.
The European Myelofibrosis Network (EUMNET), a European research network on myelofibrosis with myeloid metaplasia (MMM), has developed a definition of response for the disease by using clinicohematologic, histologic, and cytogenetic criteria. A core set of 5 clinicohematologic criteria was selected out of 9 candidates on the basis of their sensitivity to change measured in 196 patients treated either during clinical trials or routine clinical practice. A consensus panel of 16 international experts was convened and asked to score the level of response in 104 patient profiles as major, moderate, minor, or no response according to changes of the clinicohematologic criteria. Using the experts' consensus as the gold standard, the performance of 100 possible definitions of response was evaluated. Criteria for major or moderate clinicohematologic response were determined to be changes in hemoglobin (Hb) and spleen size and the presence of constitutional symptoms, while changes in platelet count and white blood cell (WBC) count served as complementary criteria and were of value for defining minor responses. A histologic response was defined by changes in bone marrow fibrosis and cellularity grades. The combined use of these response definitions should help standardize the design and reporting of future clinical studies in MMM. (Blood. 2005;106:2849-2853)
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