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Bone Marrow Transplant. 2019 Oct 23. doi: 10.1038/s41409-019-0720-0. [Epub ahead of print]

Fludarabine/busulfan versus fludarabine/total-body-irradiation (2 Gy) as conditioning prior to allogeneic stem cell transplantation in patients (≥60 years) with acute myelogenous leukemia: a study of the acute leukemia working party of the EBMT.

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Department of Hematology and Oncology, Otto-von-Guericke University, Magdeburg, Germany.
Department of Hematology and Cell Therapy and ALWP EBMT Office, Hospital Saint Antoine Paris, Paris, France.
Medical Clinic and Policlinic 1, Hematology and Cellular Therapy, University Hospital Leipzig, Leipzig, Germany.
Bone Marrow Transplant Unit L 4043, National University Hospital, Rigshospitalet, Copenhagen, Denmark.
Department of Hematology, University Medical Center Groningen (UMCG), Groningen, The Netherlands.
Department of Hematology, Erasmus MC Cancer Institute, University Medical Center Rotterdam, Rotterdam, The Netherlands.
Institut Paoli Calmettes, Department of Hematology, Centre de Recherche en Cancérologie de Marseille (CRCM), Marseille, France.
Department of Haematology, University Medical Centre, Utrecht, The Netherlands.
University Hospital Maastricht Dept. Internal Med.Hematology/Oncology, Maastricht, Maastricht, The Netherlands.
Department of Hematology, Radboud University Medical Centre, Nijmegen, The Netherlands.
Department of Haematological Medicine, GKT School of Medicine, King's College Hospital, London, UK.
Département d'Hématologie Clinique, CHU Lapeyronie, Montpellier, France.
Department of Medicine, Division of Hematology-Oncology, Vanderbilt University Medical Center, Brentwood, TN, USA.
Hematology Division and Bone Marrow Transplantation, Chaim Sheba Medical Center, Tel-Hashomer and Tel Aviv University, Tel-Aviv, Israel.
ALWP EBMT Office, Hospital Saint Antoine Paris, Paris, France.


Nonmyeloablative (NMA) conditioning regimens facilitate allogeneic stem cell transplantation (alloSCT) in elderly patients and/or in those with comorbidities. The acute leukemia working party (ALWP) of the European Society for Blood and Marrow Transplantation (EBMT) compared the outcomes of patients ≥60 years with AML in first complete remission (CR1), that had received an alloSCT following NMA conditioning, i.e. either fludarabine/busulfan (FB2) or fludarabine/total-body-irradiation-2Gy (FluTBI2Gy). A total of 1088 patients were included (median age 65 years). Donors were matched siblings (MSD) and matched unrelated donors (MUD) in 47% and 53%, respectively. In vivo T-cell depletion (TCD) was applied to 79% and none (0%) of patients in the FB2 and FluTBI2Gy groups, respectively. In the MSD group we found a trend for less extensive cGVHD in patients receiving FB2 with in vivo TCD, HR: 0.49, p = 0.08, and in those without worse NRM, HR: 2.14, p = 0.04, and a trend for more total cGVHD, HR: 1.61, p = 0.09. Patients transplanted from MUDs had a significantly higher incidence of total cGVHD, extensive cGVHD and a worse GRFS with FluTBI2Gy in comparison to FB2, HR: 2.44; p < 0.0001; HR 4.59; p < 0.00001 and HR: 1.35; p = 0.03, respectively. No differences were observed with respect to LFS, OS, RI, NRM, and aGVHD.


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