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Blood, 1 June 2007, Vol. 109, No. 11, pp. 4686-4692.
Prepublished online as a Blood First Edition Paper on February 22, 2007; DOI 10.1182/blood-2006-11-055186.


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Submitted November 3, 2006
Accepted January 18, 2007

Drug treatment is superior to allografting as first line therapy in chronic myeloid leukemia

Rudiger Hehlmann*, Ute Berger, Markus Pfirrmann, Hermann Heimpel, Andreas Hochhaus, Joerg Hasford, Hans-Jochem Kolb, Tanja Lahaye, Ole Maywald, Andreas Reiter, Dieter K Hossfeld, Christoph Huber, Helmut Loffler, Hans Pralle, Wolfgang Queisser, Andreas Tobler, Christoph Nerl, Max Solenthaler, M E Goebeler, Martin Griesshammer, Thomas Fischer, Stephan Kremers, Hartmut Eimermacher, Michael Pfreundschuh, Wolf-Dietrich Hirschmann, Klaus Lechner, Barbara Wassmann, Christiane Falge, Hartmut H Kirchner, and Alois Gratwohl

III. Medizinische Universitatsklinik, Medizinische Fakultat Mannheim der Universitat Heidelberg, Mannheim, Germany
Gesellschaft fur Informationsverarbeitung und Statistik (GIS), Munich, Germany
Universitat Ulm, Medizinische Universitatsklinik und Poliklinik, Ulm, Germany
Institut fur Medizinische Informationsverarbeitung, Biometrie und Epidemologie (IBE) der LMU Munchen, Munich, Germany
Klinikum GroBhadern der LMU Munchen, Medizinische Klinik III, Munich, Germany
Universitatsklinikum Hamburg-Eppendorf, Klinik und Poliklinik fur Innere Medizin II, Hamburg, Germany
Klinikum der J. Gutenberg Universitat, Abt. fur Hamatologie, Mainz, Germany
St. Peter, Germany
Klinikum Giessen, Medizinische Klinik IV, Giessen, Germany
Inselspital Bern, Hamatologisches Zentrallabor, Bern, Switzerland
Krankenhaus Munchen Schwabing, I. Med. Abteilung, Hamatologie und Onkologie, Munich, Germany
Medizinische Poliklinik der Universitat Wurzburg, Wurzburg, Germany
Medizinische Universitatsklinik, Abteilung Innere Medizin III, Ulm, Germany
Caritas-Krankenhaus Lebach, Innere Abteilung/Hamatologie/Onkologie, Lebach, Germany
Klinik fur Hamatologie und Onkologie, Kath. Krankenhaus Hagen, St.-Johannes-/St.-Josefs-/St. Marien-Hospital, Hagen, Germany
Universitatsklinik Homburg, Innere Medizin I, Homburg, Germany
Klinikum Kassel, Abteilung fur Onkologie, Kassel, Germany
Univ.-Klinik f. Innere Med. I, Allg. Hamatologie/Hamostaseologie, Wien, Austria
Klinikum der Johann Wolfgang Goethe-Universitat, Hamatologische Ambulanz, Frankfurt, Germany
Klinikum Nord, Institut fur Onkologie, Hamatologie und Knochenmarktransplantationen, Medizinische Klinik 5, Nurnberg, Germany
Klinikum Hannover Siloah, Medizinische Klinik III, Hamatologie/Onkologie, Hannover, Germany
Kantonsspital Basel, Bereich Innere Medizin I, Basel, Switzerland

* Corresponding author; email: r.hehlmann{at}urz.uni-heidelberg.de.

Early allogeneic hematopoietic stem cell transplantation (HSCT) has been proposed as primary treatment modality for patients with chronic myeloid leukemia (CML). This concept has been challenged by transplantation mortality and improved drug therapy. In a randomized study primary HSCT and best available drug treatment (IFN-based) were compared in newly diagnosed chronic phase CML patients. Assignment to treatment strategy was by genetic randomization according to availability of a matched related donor. Evaluation followed the intention-to-treat principle. 621 patients with chronic phase CML were stratified for eligibility for HSCT. 354 patients (62%, male; median age 40 (11-59) years) were eligible and randomized. 135 patients (38 %) had a matched related donor of which 123 (91%) received a transplant within a median of 10 (2-106) months from diagnosis. 219 patients (62%) had no related donor and received best available drug treatment. With an observation time up to 11.2 (median 8.9) years survival was superior for patients with drug treatment (p=0.049), superiority being most pronounced in low risk patients (p=0.032). The general recommendation of HSCT as first line treatment option in chronic phase CML can no longer be maintained. It should be replaced by a trial with modern drug treatment first.


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