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Non-myeloablative allogeneic hematopoietic cell transplantation following fludarabine plus 2 Gy TBI or ATG plus 8 Gy TLI: a phase II randomized study from the Belgian Hematological Society

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Abstract
Background: Few studies thus far have compared head-to-head different non-myelooablative conditioning regimens for allogeneic hematopoietic cell transplantation (allo-HCT). Methods: Here, we report the results of a phase II multicenter randomized study comparing non-myeloablative allo-HCT from HLA-identical siblings (n = 54) or from 10/10 HLA-matched unrelated donors (n = 40) with either fludarabine plus 2 Gy total body irradiation (Flu-TBI arm; n = 49) or 8 Gy TLI + anti-thymocyte globulin (TLI-ATG arm; n = 45) conditioning. Results: The 180-day cumulative incidences of grade II-IV acute GVHD (primary endpoint) were 12.2% versus 8.9% in Flu-TBI and TLI-ATG patients, respectively (P = 0.5). Two-year cumulative incidences of moderate/severe chronic GVHD were 40.8% versus 17.8% in Flu-TBI and TLI-ATG patients, respectively (P = 0.017). Five Flu-TBI patients and 10 TLI-ATG patients received pre-emptive DLI for low donor chimerism levels, while 1 Flu-TBI patient and 5 TLI-ATG patients (including 2 patients given prior pre-emptive DLIs) received a second HCT for poor graft function, graft rejection, or disease progression. Four-year cumulative incidences of relapse/progression were 22% and 50% in Flu-TBI and TLI-ATG patients, respectively (P = 0.017). Four-year cumulative incidences of nonrelapse mortality were 24% and 13% in Flu-TBI and TLI-ATG patients, respectively (P = 0.5). Finally, 4-year overall (OS) and progression-free survivals (PFS) were 53% and 54%, respectively, in the Flu-TBI arm, versus 54% (P = 0.9) and 37% (P = 0.12), respectively, in the TLI-ATG arm. Conclusions: In comparison to patients included in the Flu-TBI arm, patients included in the TLI-ATG arm had lower incidence of chronic GVHD, higher incidence of relapse and similar OS.
Keywords
ATG, TLI, TBI, Non-myeloablative conditioning, allo-HCT, GVHD, Graft-versus-leukemia effects, VERSUS-HOST-DISEASE, TOTAL LYMPHOID IRRADIATION, LEUKEMIA WORKING PARTY, MYCOPHENOLATE-MOFETIL, MARROW-TRANSPLANTATION, ANTITHYMOCYTE GLOBULIN, MALIGNANT DISEASES, EUROPEAN GROUP, OLDER PATIENTS, RELAPSE RISK

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Chicago
Baron, Frédéric, Pierre Zachée, Johan Maertens, Tessa Kerre, Aurélie Ory, Laurence Seidel, Carlos Graux, et al. 2015. “Non-myeloablative Allogeneic Hematopoietic Cell Transplantation Following Fludarabine Plus 2 Gy TBI or ATG Plus 8 Gy TLI: a Phase II Randomized Study from the Belgian Hematological Society.” Journal of Hematology & Oncology 8.
APA
Baron, F., Zachée, P., Maertens, J., Kerre, T., Ory, A., Seidel, L., Graux, C., et al. (2015). Non-myeloablative allogeneic hematopoietic cell transplantation following fludarabine plus 2 Gy TBI or ATG plus 8 Gy TLI: a phase II randomized study from the Belgian Hematological Society. JOURNAL OF HEMATOLOGY & ONCOLOGY, 8.
Vancouver
1.
Baron F, Zachée P, Maertens J, Kerre T, Ory A, Seidel L, et al. Non-myeloablative allogeneic hematopoietic cell transplantation following fludarabine plus 2 Gy TBI or ATG plus 8 Gy TLI: a phase II randomized study from the Belgian Hematological Society. JOURNAL OF HEMATOLOGY & ONCOLOGY. 2015;8.
MLA
Baron, Frédéric et al. “Non-myeloablative Allogeneic Hematopoietic Cell Transplantation Following Fludarabine Plus 2 Gy TBI or ATG Plus 8 Gy TLI: a Phase II Randomized Study from the Belgian Hematological Society.” JOURNAL OF HEMATOLOGY & ONCOLOGY 8 (2015): n. pag. Print.
@article{5968509,
  abstract     = {Background: Few studies thus far have compared head-to-head different non-myelooablative conditioning regimens for allogeneic hematopoietic cell transplantation (allo-HCT). 
Methods: Here, we report the results of a phase II multicenter randomized study comparing non-myeloablative allo-HCT from HLA-identical siblings (n = 54) or from 10/10 HLA-matched unrelated donors (n = 40) with either fludarabine plus 2 Gy total body irradiation (Flu-TBI arm; n = 49) or 8 Gy TLI + anti-thymocyte globulin (TLI-ATG arm; n = 45) conditioning. 
Results: The 180-day cumulative incidences of grade II-IV acute GVHD (primary endpoint) were 12.2% versus 8.9% in Flu-TBI and TLI-ATG patients, respectively (P = 0.5). Two-year cumulative incidences of moderate/severe chronic GVHD were 40.8% versus 17.8% in Flu-TBI and TLI-ATG patients, respectively (P = 0.017). Five Flu-TBI patients and 10 TLI-ATG patients received pre-emptive DLI for low donor chimerism levels, while 1 Flu-TBI patient and 5 TLI-ATG patients (including 2 patients given prior pre-emptive DLIs) received a second HCT for poor graft function, graft rejection, or disease progression. Four-year cumulative incidences of relapse/progression were 22% and 50% in Flu-TBI and TLI-ATG patients, respectively (P = 0.017). Four-year cumulative incidences of nonrelapse mortality were 24% and 13% in Flu-TBI and TLI-ATG patients, respectively (P = 0.5). Finally, 4-year overall (OS) and progression-free survivals (PFS) were 53% and 54%, respectively, in the Flu-TBI arm, versus 54% (P = 0.9) and 37% (P = 0.12), respectively, in the TLI-ATG arm. 
Conclusions: In comparison to patients included in the Flu-TBI arm, patients included in the TLI-ATG arm had lower incidence of chronic GVHD, higher incidence of relapse and similar OS.},
  articleno    = {4},
  author       = {Baron, Frédéric and Zachée, Pierre and Maertens, Johan and Kerre, Tessa and Ory, Aurélie and Seidel, Laurence and Graux, Carlos and Lewalle, Philippe and Van Gelder, Michel and Theunissen, Koen and Willems, Evelyne and Emonds, Marie-Paule and De Becker, Ann and Beguin, Yves},
  issn         = {1756-8722},
  journal      = {JOURNAL OF HEMATOLOGY & ONCOLOGY},
  keywords     = {ATG,TLI,TBI,Non-myeloablative conditioning,allo-HCT,GVHD,Graft-versus-leukemia effects,VERSUS-HOST-DISEASE,TOTAL LYMPHOID IRRADIATION,LEUKEMIA WORKING PARTY,MYCOPHENOLATE-MOFETIL,MARROW-TRANSPLANTATION,ANTITHYMOCYTE GLOBULIN,MALIGNANT DISEASES,EUROPEAN GROUP,OLDER PATIENTS,RELAPSE RISK},
  language     = {eng},
  pages        = {8},
  title        = {Non-myeloablative allogeneic hematopoietic cell transplantation following fludarabine plus 2 Gy TBI or ATG plus 8 Gy TLI: a phase II randomized study from the Belgian Hematological Society},
  url          = {http://dx.doi.org/10.1186/s13045-014-0098-9},
  volume       = {8},
  year         = {2015},
}

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