title: Splenic irradiation before hematopoietic stem cell transplantation for chronic myeloid leukemia: long-term follow-up of a prospective randomized study.
abstract: In the context of discussions on the reproducibility of clinical studies, we reanalyzed a prospective randomized study on the role of splenic irradiation as adjunct to the conditioning for hematopoietic stem cell transplantation (HSCT) for chronic myeloid leukemia (CML). Between 1986 and 1989, a total of 229 patients with CML were randomized; of these, 225 (98 %; 112 with, 113 without splenic irradiation) could be identified in the database and their survival updated. Results confirmed the early findings with no significant differences in all measured endpoints (overall survival at 25 years: 42.7 %, 32.0-52.4 % vs 52.9 %, 43.2-62.6 %; p = 0.355, log rank test). Additional splenic irradiation failed to reduce relapse incidence. It did not increase non-relapse mortality nor the risk of late secondary malignancies. Comforting are the long-term results from this predefined consecutive cohort of patients: more than 60 % were alive at plus 25 years when they were transplanted with a low European Society for Blood and Marrow Transplantation (EBMT) risk sore. This needs to be considered today when treatment options are discussed for patients who failed initial tyrosine kinase inhibitor therapy and have an available low risk HLA-identical donor.
authors.affiliation: The European Society for Blood and Marrow Transplantation (EBMT) Activity Survey Office, University Hospital, Basel, CH-4031, Basel, Switzerland.
authors.forename: Alois
authors.initials: A
authors.lastname: Gratwohl
authors.affiliation: Centro Interdipartimentale di Biostatistica e Bioinformatica, Università di Roma Tor Vergata, Rome, Italy.
authors.forename: Simona
authors.initials: S
authors.lastname: Iacobelli
authors.affiliation: EBMT Data Office Leiden, Leiden, The Netherlands.
authors.forename: Natalia
authors.initials: N
authors.lastname: Bootsman
authors.affiliation: EBMT Data Office Leiden, Leiden, The Netherlands.
authors.forename: Anja
authors.initials: A
authors.lastname: van Biezen
authors.affiliation: The European Society for Blood and Marrow Transplantation (EBMT) Activity Survey Office, University Hospital, Basel, CH-4031, Basel, Switzerland. helen.baldomero@usb.ch.
authors.forename: Helen
authors.initials: H
authors.lastname: Baldomero
authors.affiliation: Rome Transplant Network, ¨Tor Vergata¨ University of Rome, Stem Cell Transplant Unit, Policlinico Universitario Tor Vergata, Rome, Italy.
authors.forename: William
authors.initials: W
authors.lastname: Arcese
authors.affiliation: Hematology-Oncology, Charité Universitätsmedizin, Campus Virchow Klinikum, Berlin, Germany.
authors.forename: Renate
authors.initials: R
authors.lastname: Arnold
authors.affiliation: Experimental Hematology, Institut Jules Bordet, Brussels, Belgium.
authors.forename: Dominique
authors.initials: D
authors.lastname: Bron
authors.affiliation: Hematology, Hôpital Mondor, Créteil, France.
authors.forename: Catherine
authors.initials: C
authors.lastname: Cordonnier
authors.affiliation: King Faisal Specialist Hospital & Research Centre, Oncology, Section of Adult Haematolgy/BMT, Riyadh, Saudi Arabia.
authors.forename: Peter
authors.initials: P
authors.lastname: Ernst
authors.affiliation: Department of Haematology, Cliniques Universitaires St. Luc, Brussels, Belgium.
authors.forename: Augustin
authors.initials: A
authors.lastname: Ferrant
authors.affiliation: Department of Haematology II, Ospedale San Martino, Genova, Italy.|Ospedale Gaslini, Genova, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Frassoni
authors.affiliation: Department of Hematology, Karolinska University Hospital, Stockholm, Sweden.
authors.forename: Gösta
authors.initials: G
authors.lastname: Gahrton
authors.affiliation: Hospital U. Marqués de Valdecilla, Servicio de Hematología-Hemoterapia, c/ Marqués de Valdecilla, Santander, Spain.
authors.forename: Carlos
authors.initials: C
authors.lastname: Richard
authors.affiliation: Klinikum Grosshadern, Med. Klinik III, Munich, Germany.
authors.forename: Hans Jochem
authors.initials: HJ
authors.lastname: Kolb
authors.affiliation: Medizinische Hochschule Hannover, Hannover, Germany.|Westpfalzklinikum, Kaiserslautern, Germany.
authors.forename: Hartmut
authors.initials: H
authors.lastname: Link
authors.affiliation: Universitätsklinikum, Hämatologie, Innsbruck, Austria.|Hematology-Oncology, University Hospital, Leipzig, Germany.
authors.forename: Dietger
authors.initials: D
authors.lastname: Niederwieser
authors.affiliation: University of Helsinki Hospital, Helsinki, Finland.
authors.forename: Tapani
authors.initials: T
authors.lastname: Ruutu
authors.affiliation: Department of Hematology, Radboud University Medical Center, Nijmegen, The Netherlands.
authors.forename: Anton
authors.initials: A
authors.lastname: Schattenberg
authors.affiliation: Department of Hematology, Asklepios Klinik St. Georg, Hamburg, Germany.
authors.forename: Norbert
authors.initials: N
authors.lastname: Schmitz
authors.affiliation: Hematology, Hospital Reina Sofia, Córdoba, Spain.
authors.forename: Antonio
authors.initials: A
authors.lastname: Torres-Gomez
authors.affiliation: Leiden University Medical Center, Leiden, The Netherlands.
authors.forename: Ferry
authors.initials: F
authors.lastname: Zwaan
authors.affiliation: Department of Haematology, Imperial College, Hammersmith Hospital, London, UK.
authors.forename: Jane
authors.initials: J
authors.lastname: Apperley
authors.affiliation: Department of Haematology, Complejo Hospitalario de Navarra, Pamplona, Spain.
authors.forename: Eduardo
authors.initials: E
authors.lastname: Olavarria
authors.affiliation: Hematology, University Hospital Hamburg, Hamburg, Germany.
authors.forename: Nicolaus
authors.initials: N
authors.lastname: Kröger
mesh_terms: D000293:Adolescent; D000328:Adult; D002648:Child; D015331:Cohort Studies; D005260:Female; D005500:Follow-Up Studies; D018380:Hematopoietic Stem Cell Transplantation / Q000639:trends*; D006801:Humans; D015464:Leukemia, Myelogenous, Chronic, BCR-ABL Positive / Q000175:diagnosis* / Q000532:radiotherapy*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D013154:Spleen / Q000528:radiation effects*; D013997:Time Factors; D019172:Transplantation Conditioning / Q000379:methods / Q000639:trends*; D055815:Young Adult
keywords: CML; HSCT; Long-term follow-up; Randomized trial; Splenic irradiation