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

Baron, Frédéric;Zachée, Pierre;Maertens, Johan;Kerre, Tessa;Beguin, Yves;et.al.
(2015) Journal of Hematology & Oncology — Vol. 8, n° 1, p. 4 [1-8] (2015)

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Authors
  • Baron, Frédéric
    Author
  • Zachée, Pierre
    Author
  • Maertens, Johan
    Author
  • Kerre, Tessa
    Author
  • Graux, CarlosUCLouvain
    Author
  • Beguin, Yves
    Author
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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. © 2015 Baron et al.; licensee Biomed Central.
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Baron, F., Zachée, P., Maertens, J., Kerre, T., Ory, A., Seidel, L., Graux, C., Lewalle, P., Van Gelder, M., Theunissen, K., Willems, E., Emonds, M.-P., De Becker, A., & Beguin, Y. (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(1), 4 [1-8]. https://doi.org/10.1186/s13045-014-0098-9 (Original work published 2015)