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Comparison of fludarabine/melphalan (FM140) with fludarabine/melphalan/BCNU (FBM110) in patients with relapsed/refractory AML undergoing allogeneic hematopoietic cell transplantation - a registry study on behalf of the EBMT Acute Leukemia Working Party
J. Duque-Afonso, J. Finke, M. Ngoya, JE. Galimard, J. Schetelig, M. Eder, W. Rösler, G. Bug, A. Neubauer, M. Edinger, GG. Wulf, P. Jindra, H. Einsele, M. Stelljes, D. Selleslag, EM. Wagner-Drouet, D. Bunjes, A. Spyridonidis, E. Brissot, A....
Language English Country England, Great Britain
Document type Journal Article, Comparative Study, Multicenter Study
- MeSH
- Leukemia, Myeloid, Acute * therapy mortality MeSH
- Adult MeSH
- Transplantation, Homologous methods MeSH
- Carmustine therapeutic use administration & dosage MeSH
- Middle Aged MeSH
- Humans MeSH
- Melphalan * therapeutic use administration & dosage MeSH
- Transplantation Conditioning methods MeSH
- Antineoplastic Combined Chemotherapy Protocols therapeutic use MeSH
- Recurrence MeSH
- Registries * MeSH
- Aged MeSH
- Hematopoietic Stem Cell Transplantation * methods MeSH
- Vidarabine * analogs & derivatives therapeutic use administration & dosage MeSH
- Check Tag
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Multicenter Study MeSH
- Comparative Study MeSH
The treatment of relapsed/refractory acute myeloid leukemia (AML) is associated with a dismal prognosis. The allogeneic hematopoietic cell transplantation (allo-HCT) is frequently performed as salvage therapy. Reduced intensity conditioning protocols have been developed with the aim of reducing the leukemia burden without increasing their toxicity. We compared the reduced intensity conditioning FM140 (fludarabine, 150 mg/m2; melphalan 140 mg/m2) with FBM110 (fludarabine 150 mg/m2; BCNU, also known as carmustine, 300-400 mg/m2; and melphalan 110 mg/m2). From the European Bone Marrow Transplantation (EBMT) Acute Leukemia Working Party registry, we identified 293 adult patients (FM140, n = 118 and FBM110, n = 175) with AML with relapsed/refractory disease prior to allo-HCT. There were some differences such as age (FM140 = 59.5 years vs. FBM110 = 65.1 years, p < 0.001) and graft-versus-host disease (GvHD) prophylaxis based on in vivo T-cell depletion (TCD, FM140 = 39% vs. FBM110 = 75%, p < 0.001). No differences were observed between FM140- and FBM110-treated patients regarding overall survival (OS) (2-year OS: 39.3% vs. 45.7%, p = 0.58), progression-free survival (PFS) (2-year PFS: 36.1% vs. 37.3%, p = 0.69), non-relapse mortality (NRM) (2-year NRM: 15.3% vs. 25.7%, p = 0.10) and relapse incidence (RI) (2-year RI: 48.6% vs. 37.0%, p = 0.7). In conclusion, despite differences in age and GvHD prophylaxis, AML patients with active disease undergoing allo-HCT after FBM110 conditioning showed similar outcomes compared to FM140.
Department of Hematology A Z Sint Jan Brugge Belgium
Department of Hematology and Medical Oncology University Hospital Goettingen Goettingen Germany
Department of Hematology and Oncology University Medical Center Mainz Mainz Germany
Department of Hematology and Oncology University of Regensburg Regensburg Germany
Department of Hematology Oncology Charles University Hospital Pilsen Czech Republic
Department of Hematology Oncology University of Muenster Muenster Germany
Department of Internal Medicine 3 University Hospital Ulm Ulm Germany
Department of Internal Medicine 5 University Hospital Erlangen Erlangen Germany
Department of Medicine 2 Goethe University Frankfurt am Main Germany
Division of Internal Medicine 1 University Hospital of Patras Patras Greece
EBMT Statistical Unit INSERM UMRs 938 Hôpital Saint Antoine Paris France
Hematology Division Chaim Sheba Medical Center Tel Hashomer Israel
IRCCS San Raffaele Scientific Institute University Vita Salute Milan Italy
Medical Department 1 University Hospital Carl Gustav Carus TU Dresden Dresden Germany
Medical Department 2 University Hospital Wuerzburg Wuerzburg Germany
References provided by Crossref.org
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- $a The treatment of relapsed/refractory acute myeloid leukemia (AML) is associated with a dismal prognosis. The allogeneic hematopoietic cell transplantation (allo-HCT) is frequently performed as salvage therapy. Reduced intensity conditioning protocols have been developed with the aim of reducing the leukemia burden without increasing their toxicity. We compared the reduced intensity conditioning FM140 (fludarabine, 150 mg/m2; melphalan 140 mg/m2) with FBM110 (fludarabine 150 mg/m2; BCNU, also known as carmustine, 300-400 mg/m2; and melphalan 110 mg/m2). From the European Bone Marrow Transplantation (EBMT) Acute Leukemia Working Party registry, we identified 293 adult patients (FM140, n = 118 and FBM110, n = 175) with AML with relapsed/refractory disease prior to allo-HCT. There were some differences such as age (FM140 = 59.5 years vs. FBM110 = 65.1 years, p < 0.001) and graft-versus-host disease (GvHD) prophylaxis based on in vivo T-cell depletion (TCD, FM140 = 39% vs. FBM110 = 75%, p < 0.001). No differences were observed between FM140- and FBM110-treated patients regarding overall survival (OS) (2-year OS: 39.3% vs. 45.7%, p = 0.58), progression-free survival (PFS) (2-year PFS: 36.1% vs. 37.3%, p = 0.69), non-relapse mortality (NRM) (2-year NRM: 15.3% vs. 25.7%, p = 0.10) and relapse incidence (RI) (2-year RI: 48.6% vs. 37.0%, p = 0.7). In conclusion, despite differences in age and GvHD prophylaxis, AML patients with active disease undergoing allo-HCT after FBM110 conditioning showed similar outcomes compared to FM140.
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