Allogeneic hematopoietic stem-cell transplantation for acute myeloid leukemia in remission: comparison of intravenous busulfan plus cyclophosphamide (Cy) versus total-body irradiation plus Cy as conditioning regimen--a report from the acute leukemia working party of the European group for blood and marrow transplantation.

Arnon Nagler, Vanderson Rocha, Myriam Labopin, Ali Unal, Tarek Ben Othman, Antonio Campos, Liisa Volin, Xavier Poire, Mahmoud Aljurf, T. Masszi, Gerard Socie, Henrik Sengelov, Mauricette Michallet, Jakob Passweg, Hendrik Veelken, Ibrahim Yakoub-Agha, Avichai Shimoni, Mohamad Mohty

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Abstract

Cyclophosphamide (Cy) combined with total-body irradiation (TBI) or with busulfan (Bu) are currently the most common myeloablative regimens used in allogeneic stem-cell transplantation (alloSCT) in adults with acute myelogenous leukemia (AML). Intravenous (IV) Bu has more predictable bioavailability and a safer toxicity profile than the oral formulation. Comparative studies of outcomes have been performed between oral Bu/Cy and Cy/TBI, but there have been no comparative trials in the era of IV Bu. We performed a retrospective registry-based study comparing outcomes of patients with AML in first or second remission after alloSCT from sibling donors who underwent IV Bu/Cy (n = 795) or Cy/TBI (n = 864) conditioning. Engraftment rate was 98% and 99% after IV Bu/Cy and Cy/TBI, respectively. Grade 2 to 4 acute graft-versus-host disease (GVHD) was significantly lower in the IV Bu/Cy compared with Cy/TBI group (P <.001). Similarly, chronic GVHD was significantly lower in the IV Bu/Cy compared with Cy/TBI group (P = .003). Cumulative incidence of 2-year nonrelapse mortality (NRM; ± standard deviation [SD]) was 12% ± 1% in the IV Bu/Cy group and 15% ± 2% in the Cy/TBI group (P = .14), and 2-year relapse incidence (RI; ± SD) was 26% ± 3% and 21% ± 1%, respectively (P = .012). Leukemia-free survival (LFS) rate (± SD) was 61% ± 2% after IV Bu/Cy and 64% ± 2% after Cy/TBI (P = .27). In multivariable analysis, adjusting for differences between both groups, patients who received IV Bu/Cy had lower acute and chronic GVHD, higher RI, and a trend toward lower NRM. LFS was not statistically different between the two conditioning regimens. This retrospective study shows that final outcomes after myeloablative conditioning using IV Bu/Cy were not statistically different from those after Cy/TBI.

Original languageEnglish
Pages (from-to)3549-3556
Number of pages8
JournalJournal of Clinical Oncology
Volume31
Issue number28
Publication statusPublished - Oct 1 2013

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Busulfan
Whole-Body Irradiation
Hematopoietic Stem Cell Transplantation
Blood Group Antigens
Acute Myeloid Leukemia
Cyclophosphamide
Leukemia
Transplantation
Bone Marrow
Graft vs Host Disease
Conditioning (Psychology)
Stem Cell Transplantation
Outcome Assessment (Health Care)

ASJC Scopus subject areas

  • Medicine(all)

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Allogeneic hematopoietic stem-cell transplantation for acute myeloid leukemia in remission : comparison of intravenous busulfan plus cyclophosphamide (Cy) versus total-body irradiation plus Cy as conditioning regimen--a report from the acute leukemia working party of the European group for blood and marrow transplantation. / Nagler, Arnon; Rocha, Vanderson; Labopin, Myriam; Unal, Ali; Ben Othman, Tarek; Campos, Antonio; Volin, Liisa; Poire, Xavier; Aljurf, Mahmoud; Masszi, T.; Socie, Gerard; Sengelov, Henrik; Michallet, Mauricette; Passweg, Jakob; Veelken, Hendrik; Yakoub-Agha, Ibrahim; Shimoni, Avichai; Mohty, Mohamad.

In: Journal of Clinical Oncology, Vol. 31, No. 28, 01.10.2013, p. 3549-3556.

Research output: Contribution to journalArticle

Nagler, Arnon ; Rocha, Vanderson ; Labopin, Myriam ; Unal, Ali ; Ben Othman, Tarek ; Campos, Antonio ; Volin, Liisa ; Poire, Xavier ; Aljurf, Mahmoud ; Masszi, T. ; Socie, Gerard ; Sengelov, Henrik ; Michallet, Mauricette ; Passweg, Jakob ; Veelken, Hendrik ; Yakoub-Agha, Ibrahim ; Shimoni, Avichai ; Mohty, Mohamad. / Allogeneic hematopoietic stem-cell transplantation for acute myeloid leukemia in remission : comparison of intravenous busulfan plus cyclophosphamide (Cy) versus total-body irradiation plus Cy as conditioning regimen--a report from the acute leukemia working party of the European group for blood and marrow transplantation. In: Journal of Clinical Oncology. 2013 ; Vol. 31, No. 28. pp. 3549-3556.
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abstract = "Cyclophosphamide (Cy) combined with total-body irradiation (TBI) or with busulfan (Bu) are currently the most common myeloablative regimens used in allogeneic stem-cell transplantation (alloSCT) in adults with acute myelogenous leukemia (AML). Intravenous (IV) Bu has more predictable bioavailability and a safer toxicity profile than the oral formulation. Comparative studies of outcomes have been performed between oral Bu/Cy and Cy/TBI, but there have been no comparative trials in the era of IV Bu. We performed a retrospective registry-based study comparing outcomes of patients with AML in first or second remission after alloSCT from sibling donors who underwent IV Bu/Cy (n = 795) or Cy/TBI (n = 864) conditioning. Engraftment rate was 98{\%} and 99{\%} after IV Bu/Cy and Cy/TBI, respectively. Grade 2 to 4 acute graft-versus-host disease (GVHD) was significantly lower in the IV Bu/Cy compared with Cy/TBI group (P <.001). Similarly, chronic GVHD was significantly lower in the IV Bu/Cy compared with Cy/TBI group (P = .003). Cumulative incidence of 2-year nonrelapse mortality (NRM; ± standard deviation [SD]) was 12{\%} ± 1{\%} in the IV Bu/Cy group and 15{\%} ± 2{\%} in the Cy/TBI group (P = .14), and 2-year relapse incidence (RI; ± SD) was 26{\%} ± 3{\%} and 21{\%} ± 1{\%}, respectively (P = .012). Leukemia-free survival (LFS) rate (± SD) was 61{\%} ± 2{\%} after IV Bu/Cy and 64{\%} ± 2{\%} after Cy/TBI (P = .27). In multivariable analysis, adjusting for differences between both groups, patients who received IV Bu/Cy had lower acute and chronic GVHD, higher RI, and a trend toward lower NRM. LFS was not statistically different between the two conditioning regimens. This retrospective study shows that final outcomes after myeloablative conditioning using IV Bu/Cy were not statistically different from those after Cy/TBI.",
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AU - Nagler, Arnon

AU - Rocha, Vanderson

AU - Labopin, Myriam

AU - Unal, Ali

AU - Ben Othman, Tarek

AU - Campos, Antonio

AU - Volin, Liisa

AU - Poire, Xavier

AU - Aljurf, Mahmoud

AU - Masszi, T.

AU - Socie, Gerard

AU - Sengelov, Henrik

AU - Michallet, Mauricette

AU - Passweg, Jakob

AU - Veelken, Hendrik

AU - Yakoub-Agha, Ibrahim

AU - Shimoni, Avichai

AU - Mohty, Mohamad

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N2 - Cyclophosphamide (Cy) combined with total-body irradiation (TBI) or with busulfan (Bu) are currently the most common myeloablative regimens used in allogeneic stem-cell transplantation (alloSCT) in adults with acute myelogenous leukemia (AML). Intravenous (IV) Bu has more predictable bioavailability and a safer toxicity profile than the oral formulation. Comparative studies of outcomes have been performed between oral Bu/Cy and Cy/TBI, but there have been no comparative trials in the era of IV Bu. We performed a retrospective registry-based study comparing outcomes of patients with AML in first or second remission after alloSCT from sibling donors who underwent IV Bu/Cy (n = 795) or Cy/TBI (n = 864) conditioning. Engraftment rate was 98% and 99% after IV Bu/Cy and Cy/TBI, respectively. Grade 2 to 4 acute graft-versus-host disease (GVHD) was significantly lower in the IV Bu/Cy compared with Cy/TBI group (P <.001). Similarly, chronic GVHD was significantly lower in the IV Bu/Cy compared with Cy/TBI group (P = .003). Cumulative incidence of 2-year nonrelapse mortality (NRM; ± standard deviation [SD]) was 12% ± 1% in the IV Bu/Cy group and 15% ± 2% in the Cy/TBI group (P = .14), and 2-year relapse incidence (RI; ± SD) was 26% ± 3% and 21% ± 1%, respectively (P = .012). Leukemia-free survival (LFS) rate (± SD) was 61% ± 2% after IV Bu/Cy and 64% ± 2% after Cy/TBI (P = .27). In multivariable analysis, adjusting for differences between both groups, patients who received IV Bu/Cy had lower acute and chronic GVHD, higher RI, and a trend toward lower NRM. LFS was not statistically different between the two conditioning regimens. This retrospective study shows that final outcomes after myeloablative conditioning using IV Bu/Cy were not statistically different from those after Cy/TBI.

AB - Cyclophosphamide (Cy) combined with total-body irradiation (TBI) or with busulfan (Bu) are currently the most common myeloablative regimens used in allogeneic stem-cell transplantation (alloSCT) in adults with acute myelogenous leukemia (AML). Intravenous (IV) Bu has more predictable bioavailability and a safer toxicity profile than the oral formulation. Comparative studies of outcomes have been performed between oral Bu/Cy and Cy/TBI, but there have been no comparative trials in the era of IV Bu. We performed a retrospective registry-based study comparing outcomes of patients with AML in first or second remission after alloSCT from sibling donors who underwent IV Bu/Cy (n = 795) or Cy/TBI (n = 864) conditioning. Engraftment rate was 98% and 99% after IV Bu/Cy and Cy/TBI, respectively. Grade 2 to 4 acute graft-versus-host disease (GVHD) was significantly lower in the IV Bu/Cy compared with Cy/TBI group (P <.001). Similarly, chronic GVHD was significantly lower in the IV Bu/Cy compared with Cy/TBI group (P = .003). Cumulative incidence of 2-year nonrelapse mortality (NRM; ± standard deviation [SD]) was 12% ± 1% in the IV Bu/Cy group and 15% ± 2% in the Cy/TBI group (P = .14), and 2-year relapse incidence (RI; ± SD) was 26% ± 3% and 21% ± 1%, respectively (P = .012). Leukemia-free survival (LFS) rate (± SD) was 61% ± 2% after IV Bu/Cy and 64% ± 2% after Cy/TBI (P = .27). In multivariable analysis, adjusting for differences between both groups, patients who received IV Bu/Cy had lower acute and chronic GVHD, higher RI, and a trend toward lower NRM. LFS was not statistically different between the two conditioning regimens. This retrospective study shows that final outcomes after myeloablative conditioning using IV Bu/Cy were not statistically different from those after Cy/TBI.

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