The optimal conditioning for patients with acute myeloid leukemia in first complete remission treated with allogeneic hematopoietic cell transplantation (allo-HCT) has not been defined so far. In this retrospective study, we compared two “reduced-toxicity” regimens: intravenous busulfan at a total dose of 9.6 mg/kg (3 days) + fludarabine (Bu3/Flu) and total body irradiation at a dose of 8 Gy + fludarabine (TBI8Gy/Flu). In the entire study cohort (n = 518), the probabilities of overall survival (OS), leukemia-free survival (LFS), relapse and non-relapse mortality (NRM) at 2 years for Bu3/Flu and TBI8Gy/Flu were 62% vs. 72.5% (p = 0.051), 59.5% vs. 65% (p = 0.15), 30% vs. 20% (p = 0.01), and 10% vs. 14% (p = 0.18), respectively. In multivariate model for patients <50 years old, TBI8Gy/Flu was associated with improved LFS (hazard ratio (HR) = 0.5, p = 0.04), OS (HR = 0.31, p = 0.004), and survival free from both graft-versus-host disease and relapse (HR = 0.55, p = 0.03), as well as tendency to reduced risk of relapse (HR = 0.53, p = 0.08). Among patients aged 50 years or older the use of TBI8Gy/Flu was associated with increased incidence of NRM (HR = 3.9, p = 0.0009), with no significant impact on other outcome measures. We conclude that the use of TBI8Gy/Flu as “reduced-toxicity” regimen may be advised in younger patients with AML referred for allo-HCT.

Total body irradiation plus fludarabine compared to busulfan plus fludarabine as "reduced-toxicity conditioning" for patients with acute myeloid leukemia treated with allogeneic hematopoietic cell transplantation in first complete remission: a study by the Acute Leukemia Working Party of the EBMT / S. Giebel, M. Labopin, M. Sobczyk-Kruszelnicka, M. Stelljes, J.L. Byrne, N. Fegueux, D.W. Beelen, M. Rovira, A. Spyridonidis, D. Blaise, M. Bornhauser, I. Karadogan, B.N. Savani, A. Nagler, M. Mohty, S. Martin, P. Chevallier, A. Neubauer, G. Damaj, Y. Koc, A. Ganser, M. Collin, I. Yakoub-Agha, H. Ozdogu, M.C. Araujo, M. Itala-Remes, K. Orchard, C. Isaksson, W. Bethge, H. Martin, M. Aljurf, E. Faber, D. Caballero, P. Zak, X. Leleu, J.-. Bay, P.-. Rohrlich, N. Kroger, A. Huynh, K. Schafer-Eckart, N. Milpied, S. Lenhoff, A. Ho, J.L.B. Lopez, N. Mordini, B. Lioure, K. Halaburda, A. Olivieri, T. Gedde-Dahl, R. Protheroe, J. Tischer, M. Klammer, J. Clausen, V. Potter, M. Ladetto, H. Tilly, E. Deconinck, A. Brecht, L.P. Muller, T. Heinicke, J.P.T. Carrete, A. Bazarbachi, P. Remenyi, M.T. Rubio, R. Fanin, J.A. Perez-Simon, M. Niels, J.L. Diez-Martin, M. Arat, O. Hermine, G. Socie, J.J. Cornelissen, S. Santarone, D. Guyotat, C.E. Bulabois, P. Bernasconi, J.-. Johansson, R. Vrhovac, H. Greinix, J.L.L. Lorenzo, S. Apte, C. Craddock, G. Kobbe, M.A. Zahrani, P. Dreger, A. Lange, A. Tbakhi, E. Meijer, C.V. Llamas, J.M.R. Santasusana, P. Corradini, F. Benedetti, A. Rambaldi, V. Gandemer, J.-. Malfuson, A. Kaare, A. Risitano, M. Petrini, C. Selleri, D. Wu. - In: BONE MARROW TRANSPLANTATION. - ISSN 0268-3369. - (2020). [Epub ahead of print] [10.1038/s41409-020-01050-7]

Total body irradiation plus fludarabine compared to busulfan plus fludarabine as "reduced-toxicity conditioning" for patients with acute myeloid leukemia treated with allogeneic hematopoietic cell transplantation in first complete remission: a study by the Acute Leukemia Working Party of the EBMT

P. Corradini;A. Rambaldi;
2020

Abstract

The optimal conditioning for patients with acute myeloid leukemia in first complete remission treated with allogeneic hematopoietic cell transplantation (allo-HCT) has not been defined so far. In this retrospective study, we compared two “reduced-toxicity” regimens: intravenous busulfan at a total dose of 9.6 mg/kg (3 days) + fludarabine (Bu3/Flu) and total body irradiation at a dose of 8 Gy + fludarabine (TBI8Gy/Flu). In the entire study cohort (n = 518), the probabilities of overall survival (OS), leukemia-free survival (LFS), relapse and non-relapse mortality (NRM) at 2 years for Bu3/Flu and TBI8Gy/Flu were 62% vs. 72.5% (p = 0.051), 59.5% vs. 65% (p = 0.15), 30% vs. 20% (p = 0.01), and 10% vs. 14% (p = 0.18), respectively. In multivariate model for patients <50 years old, TBI8Gy/Flu was associated with improved LFS (hazard ratio (HR) = 0.5, p = 0.04), OS (HR = 0.31, p = 0.004), and survival free from both graft-versus-host disease and relapse (HR = 0.55, p = 0.03), as well as tendency to reduced risk of relapse (HR = 0.53, p = 0.08). Among patients aged 50 years or older the use of TBI8Gy/Flu was associated with increased incidence of NRM (HR = 3.9, p = 0.0009), with no significant impact on other outcome measures. We conclude that the use of TBI8Gy/Flu as “reduced-toxicity” regimen may be advised in younger patients with AML referred for allo-HCT.
bone-marrow-transplantation; intravenous busulfan; preparative refimen; randomized-trial; open-label; cyclophosphamide; intensity; multicenter; AML; survival
Settore MED/15 - Malattie del Sangue
2020
5-set-2020
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/2434/778106
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