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Clinical Trial
. 2011 Oct;17(10):1490-6.
doi: 10.1016/j.bbmt.2011.02.007. Epub 2011 Feb 18.

Myeloablative reduced-toxicity i.v. busulfan-fludarabine and allogeneic hematopoietic stem cell transplant for patients with acute myeloid leukemia or myelodysplastic syndrome in the sixth through eighth decades of life

Gheath Alatrash  1 , Marcos de Lima, Nelson Hamerschlak, Matteo Pelosini, Xuemei Wang, Lianchun Xiao, Fabio Kerbauy, Alexandre Chiattone, Gabriela Rondon, Muzaffar H Qazilbash, Sergio A Giralt, Leandro de Padua Silva, Chitra Hosing, Partow Kebriaei, Weiqing Zhang, Yago Nieto, Rima M Saliba, Richard E Champlin, Borje S Andersson
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Clinical Trial

Myeloablative reduced-toxicity i.v. busulfan-fludarabine and allogeneic hematopoietic stem cell transplant for patients with acute myeloid leukemia or myelodysplastic syndrome in the sixth through eighth decades of life

Gheath Alatrash et al. Biol Blood Marrow Transplant. 2011 Oct.

Abstract

The optimal pretransplant regimen for acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) in patients ≥ 55 years of age remains to be determined. The myeloablative reduced-toxicity 4-day regimen i.v. busulfan (Bu) (130 mg/m(2)) and i.v. fludarabine (Flu) (40 mg/m(2)) is associated with low morbidity and mortality. We analyzed 79 patients ≥ 55 years of age (median, 58 years) with AML (n = 63) or MDS (n = 16) treated with i.v. Bu-Flu conditioning regimens between 2001 and 2009 (median follow-up, 24 months). The patients who received this regimen had a good performance status. The 2-year overall survival (OS) rates for patients in first complete remission (CR1), second CR (CR2), or refractory disease and for all patients at time of transplantation were 71%, 44%, 32%, and 46%, respectively; 2-year event-free survival (EFS) rates for patients in CR1, CR2, or refractory disease at time of transplantation and for all patients were 68%, 42%, 30%, and 44%, respectively. One-year transplant-related mortality (TRM) rates for patients who were in CR or who had active disease at the time of transplantation were 19% and 20%, respectively. Grade II-IV acute graft-versus-host (aGVHD) disease was diagnosed in 40% of the patients. Our results suggest that age alone should not be the primary reason for exclusion from receiving myeloablative reduced-toxicity conditioning with i.v. Bu-Flu preceding transplantation in patients with AML/MDS.

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Figures

Figure 1
Figure 1. Kaplan-Meier curves for OS and EFS
OS and EFS probabilities for (A-B) patients in CR1 (n=25) and (C-D) for entire cohort (n=79).
Figure 2
Figure 2. Cumulative incidence of grade II-IV acute graft-versus-host disease (GvHD)
Figure 3
Figure 3. Overall survival in patients 58 years or older versus patients younger than 58 years
NS indicates not significant.
Figure 4
Figure 4. Kaplan-Meier curve for overall survival according to remission status at time of transplantation
(A) Overall survival in patients 58 years or older versus patients younger than 58 years who underwent transplantation while their disease was in complete remission. (B) Overall survival in patients 58 years or older versus patients younger than 58 years who underwent transplantation while they had active disease. NS indicates not significant.
Figure 4
Figure 4. Kaplan-Meier curve for overall survival according to remission status at time of transplantation
(A) Overall survival in patients 58 years or older versus patients younger than 58 years who underwent transplantation while their disease was in complete remission. (B) Overall survival in patients 58 years or older versus patients younger than 58 years who underwent transplantation while they had active disease. NS indicates not significant.
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