title: Drug treatment is superior to allografting as first-line therapy in chronic myeloid leukemia.
abstract: 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.
authors.affiliation: III Medizinische Universitätsklinik, Medizinische Fakultät Mannheim der Universität Heidelberg, Wiesbadener Strasse 7-11, 63805 Mannheim, Germany. r.hehlmann@urz.uni-heidelberg.de
authors.forename: Rüdiger
authors.initials: R
authors.lastname: Hehlmann
authors.forename: Ute
authors.initials: U
authors.lastname: Berger
authors.forename: Markus
authors.initials: M
authors.lastname: Pfirrmann
authors.forename: Hermann
authors.initials: H
authors.lastname: Heimpel
authors.forename: Andreas
authors.initials: A
authors.lastname: Hochhaus
authors.forename: Joerg
authors.initials: J
authors.lastname: Hasford
authors.forename: Hans-Jochem
authors.initials: HJ
authors.lastname: Kolb
authors.forename: Tanja
authors.initials: T
authors.lastname: Lahaye
authors.forename: Ole
authors.initials: O
authors.lastname: Maywald
authors.forename: Andreas
authors.initials: A
authors.lastname: Reiter
authors.forename: Dieter K
authors.initials: DK
authors.lastname: Hossfeld
authors.forename: Christoph
authors.initials: C
authors.lastname: Huber
authors.forename: Helmut
authors.initials: H
authors.lastname: Löffler
authors.forename: Hans
authors.initials: H
authors.lastname: Pralle
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Queisser
authors.forename: Andreas
authors.initials: A
authors.lastname: Tobler
authors.forename: Christoph
authors.initials: C
authors.lastname: Nerl
authors.forename: Max
authors.initials: M
authors.lastname: Solenthaler
authors.forename: Mariele E
authors.initials: ME
authors.lastname: Goebeler
authors.forename: Martin
authors.initials: M
authors.lastname: Griesshammer
authors.forename: Thomas
authors.initials: T
authors.lastname: Fischer
authors.forename: Stephan
authors.initials: S
authors.lastname: Kremers
authors.forename: Hartmut
authors.initials: H
authors.lastname: Eimermacher
authors.forename: Michael
authors.initials: M
authors.lastname: Pfreundschuh
authors.forename: Wolf-Dietrich
authors.initials: WD
authors.lastname: Hirschmann
authors.forename: Klaus
authors.initials: K
authors.lastname: Lechner
authors.forename: Barbara
authors.initials: B
authors.lastname: Wassmann
authors.forename: Christiane
authors.initials: C
authors.lastname: Falge
authors.forename: Hartmut H
authors.initials: HH
authors.lastname: Kirchner
authors.forename: Alois
authors.initials: A
authors.lastname: Gratwohl
mesh_terms: D000293:Adolescent; D000328:Adult; D000970:Antineoplastic Agents / Q000494:pharmacology*; D002648:Child; D015331:Cohort Studies; D005260:Female; D006801:Humans; D015464:Leukemia, Myelogenous, Chronic, BCR-ABL Positive / Q000188:drug therapy* / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D011379:Prognosis; D012306:Risk; D014184:Transplantation, Homologous / Q000379:methods*; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents