BACKGROUND: The optimal intensity of reduced-intensity conditioning (RIC) before allogeneic hematopoietic stem cell transplantation (allo-HSCT) remains uncertain. METHODS: In this centrally randomized phase 2 study, the authors compared 2 different strategies of RIC. In total, 139 patients (median age, 54 years; range, 21-65 years) with hematologic malignancies underwent allo-HSCT from a human leukocyte antigen-identical sibling after conditioning combiningfludarabine with either busulfan and rabbit antithymocyte-globulin (BU-rATG) (n = 69) or total body irradiation (TBI) (n = 70). Postgraft immunosuppression consisted of cyclosporin A in all patients with the addition of mycophenolate-mophetil after TBI. RESULTS: The median follow-up was 54 months (range, 26-88 months). One-year overall survival rate was identical in both groups. Four patients experienced graft-failure after TBI. The incidence of grade 2 through 4 acute graft-versus-host-disease was greater after BU-rATG than after TBI (47% vs 27%; P = .01), whereas no difference was observed with chronic graft-versus-host-disease. The BU-rATG group had a higher objective response rate (65% vs 46%; P = .05) and a lower relapse rate (27% vs 54%; P < .01). However, the nonrelapse mortality rate was higher after BU-rATG than after TBI (38% vs 22%; P = .027). At 5 years, the overall and progression-free survival rates were 41% and 29%, respectively, and did not differ statistically between groups. A detrimental effect on some parameters of quality of life was more pronounced after BU-rATG, but recovery was identical in both groups. The mean total cost per patient, including the cost to treat disease progression post-transplantation, did not differ statistically between groups. CONCLUSIONS: Five years after transplantation, the BU-rATG regimen was associated with greater disease control. However, because of the higher nonrelapse mortality rate, this did not translate into better overall or progression-free survival.
RCT Entities:
BACKGROUND: The optimal intensity of reduced-intensity conditioning (RIC) before allogeneic hematopoietic stem cell transplantation (allo-HSCT) remains uncertain. METHODS: In this centrally randomized phase 2 study, the authors compared 2 different strategies of RIC. In total, 139 patients (median age, 54 years; range, 21-65 years) with hematologic malignancies underwent allo-HSCT from a human leukocyte antigen-identical sibling after conditioning combining fludarabine with either busulfan and rabbit antithymocyte-globulin (BU-rATG) (n = 69) or total body irradiation (TBI) (n = 70). Postgraft immunosuppression consisted of cyclosporin A in all patients with the addition of mycophenolate-mophetil after TBI. RESULTS: The median follow-up was 54 months (range, 26-88 months). One-year overall survival rate was identical in both groups. Four patients experienced graft-failure after TBI. The incidence of grade 2 through 4 acute graft-versus-host-disease was greater after BU-rATG than after TBI (47% vs 27%; P = .01), whereas no difference was observed with chronic graft-versus-host-disease. The BU-rATG group had a higher objective response rate (65% vs 46%; P = .05) and a lower relapse rate (27% vs 54%; P < .01). However, the nonrelapse mortality rate was higher after BU-rATG than after TBI (38% vs 22%; P = .027). At 5 years, the overall and progression-free survival rates were 41% and 29%, respectively, and did not differ statistically between groups. A detrimental effect on some parameters of quality of life was more pronounced after BU-rATG, but recovery was identical in both groups. The mean total cost per patient, including the cost to treat disease progression post-transplantation, did not differ statistically between groups. CONCLUSIONS: Five years after transplantation, the BU-rATG regimen was associated with greater disease control. However, because of the higher nonrelapse mortality rate, this did not translate into better overall or progression-free survival.
Authors: B K Hamilton; L Rybicki; J Dabney; L McLellan; H Haddad; L Foster; D Abounader; M Kalaycio; R Sobecks; R Dean; H Duong; B T Hill; B J Bolwell; E A Copelan Journal: Bone Marrow Transplant Date: 2014-07-28 Impact factor: 5.483
Authors: L Castagna; R Crocchiolo; S Furst; J El-cheikh; B Esterni; A Granata; A Stoppa; R Boubdallah; D Coso; N Vey; A Charbonnier; C Lemarie; C Faucher; C Chabannon; D Blaise Journal: Bone Marrow Transplant Date: 2014-07-07 Impact factor: 5.483
Authors: M A Kharfan-Dabaja; N El-Jurdi; E Ayala; A S Kanate; B N Savani; M Hamadani Journal: Bone Marrow Transplant Date: 2017-04-03 Impact factor: 5.483
Authors: L Pascal; M Mohty; A Ruggeri; L Tucunduva; N Milpied; P Chevallier; R Tabrizi; M Labalette; E Gluckman; M Labopin; I Yakoub-Agha Journal: Bone Marrow Transplant Date: 2014-10-20 Impact factor: 5.483
Authors: G S Hobbs; N Kaur; P Hilden; D Ponce; C Cho; H R Castro-Malaspina; S Giralt; J D Goldberg; A A Jakubowski; E B Papadopoulos; C Sauter; G Koehne; J Yahalom; S Delvin; J N Barker; M-A Perales Journal: Bone Marrow Transplant Date: 2016-03-14 Impact factor: 5.483
Authors: Frédéric Baron; Pierre Zachée; Johan Maertens; Tessa Kerre; Aurélie Ory; Laurence Seidel; Carlos Graux; Philippe Lewalle; Michel Van Gelder; Koen Theunissen; Evelyne Willems; Marie-Paule Emonds; Ann De Becker; Yves Beguin Journal: J Hematol Oncol Date: 2015-02-06 Impact factor: 17.388