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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.
 Previous Article | Table of Contents | Next Article 
CLINICAL TRIALS AND OBSERVATIONS
Drug treatment is superior to allografting as first-line therapy in chronic myeloid leukemia
Rüdiger Hehlmann1,
Ute Berger1,
Markus Pfirrmann2,
Hermann Heimpel3,
Andreas Hochhaus1,
Joerg Hasford4,
Hans-Jochem Kolb5,
Tanja Lahaye1,
Ole Maywald1,
Andreas Reiter1,
Dieter K. Hossfeld6,
Christoph Huber7,
Helmut Löffler8,
Hans Pralle9,
Wolfgang Queisser1,
Andreas Tobler10,
Christoph Nerl11,
Max Solenthaler10,
Mariele E. Goebeler12,
Martin Griesshammer13,
Thomas Fischer7,
Stephan Kremers14,
Hartmut Eimermacher15,
Michael Pfreundschuh16,
Wolf-Dietrich Hirschmann17,
Klaus Lechner18,
Barbara Wassmann19,
Christiane Falge20,
Hartmut H. Kirchner21,
Alois Gratwohl22, for the Schweizerische Arbeitsgemeinschaft für Klinische Krebsforschung (SAKK) and the German CML Study Group
1 III Medizinische Universitätsklinik, Medizinische Fakultät Mannheim der Universität Heidelberg, Mannheim, Germany;
2 Gesellschaft für Informationsverarbeitung und Statistik (GIS), Munich, Germany;
3 Universität Ulm, Medizinische Universitätsklinik und Poliklinik, Ulm, Germany;
4 Institut für Medizinische Informationsverarbeitung, Biometrie und Epidemologie (IBE) der LMU München, Munich, Germany;
5 Klinikum Großhadern der LMU München, Medizinische Klinik III, Munich, Germany;
6 Universitätsklinikum Hamburg-Eppendorf, Klinik und Poliklinik für Innere Medizin II, Hamburg, Germany;
7 Klinikum der J. Gutenberg Universität, Abt für Hämatologie, Mainz, Germany;
8 St Peter, Germany;
9 Klinikum Giessen, Medizinische Klinik IV, Giessen, Germany;
10 Inselspital Bern, Hämatologisches Zentrallabor, Bern, Switzerland;
11 Krankenhaus München Schwabing, I Med Abteilung, Hämatologie und Onkologie, Munich, Germany;
12 Medizinische Poliklinik der Universität Würzburg, Würzburg, Germany;
13 Medizinische Universitätsklinik, Abteilung Innere Medizin III, Ulm, Germany;
14 Caritas-Krankenhaus Lebach, Innere Abteilung/Hämatologie/Onkologie, Lebach, Germany;
15 Klinik für Hämatologie und Onkologie, Kath Krankenhaus Hagen, St-Johannes-/St-Josefs-/St Marien-Hospital, Hagen, Germany;
16 Universitätsklinik Homburg, Innere Medizin I, Homburg, Germany;
17 Klinikum Kassel, Abteilung für Onkologie, Kassel, Germany;
18 Univ-Klinik f Innere Med I, Allg Hämatologie/Hämostaseologie, Wien, Austria;
19 Klinikum der Johann Wolfgang Goethe-Universität, Hämatologische Ambulanz, Frankfurt, Germany;
20 Klinikum Nord, Institut für Onkologie, Hämatologie und Knochenmarktransplantationen, Medizinische Klinik 5, Nürnberg, Germany;
21 Klinikum Hannover Siloah, Medizinische Klinik III, Hämatologie/Onkologie, Hannover, Germany;
22 Kantonsspital Basel, Bereich Innere Medizin I, Basel, Switzerland
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. Six hundred and twenty one patients with chronic phase CML were stratified for eligibility for HSCT. Three hundred and fifty four patients (62% male; median age, 40 years; range, 11-59 years) were eligible and randomized. One hundred and thirty five patients (38%) had a matched related donor, of whom 123 (91%) received a transplant within a median of 10 months (range, 2-106 months) from diagnosis. Two hundred and nineteen patients (62%) had no related donor and received best available drug treatment. With an observation time up to 11.2 years (median, 8.9 years), survival was superior for patients with drug treatment (P = .049), superiority being most pronounced in low-risk patients (P = .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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