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Blood, 1 November 2005, Vol. 106, No. 9, pp. 2969-2976.
Prepublished online as a Blood First Edition Paper on July 5, 2005; DOI 10.1182/blood-2004-09-3544.
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CLINICAL TRIALS AND OBSERVATIONS
Outcomes of reduced-intensity transplantation for chronic myeloid leukemia: an analysis of prognostic factors from the Chronic Leukemia Working Party of the EBMT
Charles Crawley,
Richard Szydlo,
Marc Lalancette,
Andrea Bacigalupo,
Andrzej Lange,
Mats Brune,
Gunnar Juliusson,
Arnon Nagler,
Alois Gratwohl,
Jakob Passweg,
Mieczys aw Komarnicki,
Antonin Vitek,
Jiri Mayer,
Axel Zander,
Jorge Sierra,
Alessandro Rambaldi,
Olle Ringden,
Dietger Niederwieser,
Jane F. Apperley, for the Chronic Leukemia Working Party of the EBMT
From Addenbrookes Hospital, Cambridge, United Kingdom; Imperial College School of Medicine, Hammersmith Hospital, London, United Kingdom; the Centre Hospitalier Universitaire de Quebec (CHUQ), L'Hôtel-Dieu, Quebec, Canada; the Ospedale San Martino, Genova, Italy; the Lower Silesian Centre for Cellular Transplantation, Wroclaw, Poland; the Sahlgrenska University Hospital, Goeteborg, Sweden; the University Hospital, Lund, Sweden; the Chaim Sheba Medical Center, Tel-Hashomer, Israel; the University Hospital, Basel, Switzerland; the University of Medical Sciences, Poznan, Poland; the Institute of Hematology and Blood Transfusion, Prague, Czech Republic; the University Hospital Brno, Brno, Czech Republic; the University Hospital Eppendorf, Hamburg, Germany; the Hospital Santa Creu I Sant Pau, Barcelona, Spain; the Ospedale Bergamo, Bergamo, Italy; the Huddinge University Hospital, Huddinge, Sweden; and the University of Leipzig, Leipzig, Germany.
This study reports outcomes of allogeneic hematopoietic stem cell transplantation with reduced-intensity conditioning (RIC) in 186 patients with chronic myeloid leukemia (CML) from the European Group for Blood and Marrow Transplantation (EBMT). The median age was 50 years, and 64% were in first chronic phase (CP1), CP2 13%, accelerated phase 17%, and blast crises 6%. The median EBMT transplant score was 3. The day 100 transplantation-related mortality (TRM) was 6.1% (confidence interval [CI], 3.4%-11%) but rose to 23.3% (CI, 14%-27%) at 2 years. Fludarabine, busulfan, and antithymocyte globulin (Fd/Bu/ATG) was associated with the lowest TRM of 11.6% (CI, 4.7%-11%) at 1 year. Acute graft-versus-host disease (GvHD) grade II to IV occurred in 32% and chronic GvHD in 43% (extensive in 24%). ATG was associated with a lower incidence of chronic GvHD (cGvHD). The overall survival (OS) and progression-free survival (PFS) at 3 years were 58% (CI, 50%-66%) and 37% (CI, 30%-45%), respectively. Adverse OS was associated with advanced disease (relative risk [RR], 3.4). PFS was inferior in advanced disease (RR, 2.7) and a trend to improved outcomes with Fd/Bu/ATG (RR, 0.58). RIC allografts are feasible in CML in first or second CP. Since no other RIC regimen demonstrated superiority, Fd/Bu/ATG should be considered as baseline in future prospective trials.
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