Patients with acute graft-versus-host disease (GvHD) grade I were randomized to an observation arm (n=85) or to a treatment arm (n=86) consisting of 6-methylprednisolone 1 mg/kg/day, after stratification for age and donor type. The primary end point was development of grade II-IV GvHD. The cumulative incidence of grade II-IV GvHD was 50% in the observation arm and 33% in the treatment arm (P=0.005). However, grade III-IV GvHD was comparable (13% vs. 10%, respectively; P=0.6), and this was true for sibling and alternative donor transplants. Moderate/severe chronic GvHD was also comparable (17% vs. 9%). In multivariate analysis, an early interval between transplant and randomization (
Bacigalupo, A., Milone, G., Cupri, A., Salvemini, S. A., Fagioli, F., Berger, M., Santarone, S., Chiusolo, P., Sica, S., Mammoliti, S., Sorasio, R., Massi, D., Van Lint, M. T., Raiola, A. M., Gualandi, F., Selleri, C., Sormani, M. P., Signori, A., Risitano, A., Bonifazi, F., Steroid treatment of acute graft-versus-host disease grade I: A randomized trial, <<HAEMATOLOGICA>>, 2017; 102 (12): 2125-2133. [doi:10.3324/haematol.2017.171157] [http://hdl.handle.net/10807/122797]
Steroid treatment of acute graft-versus-host disease grade I: A randomized trial
Bacigalupo, Andrea
;Chiusolo, Patrizia;Sica, Simona;
2017
Abstract
Patients with acute graft-versus-host disease (GvHD) grade I were randomized to an observation arm (n=85) or to a treatment arm (n=86) consisting of 6-methylprednisolone 1 mg/kg/day, after stratification for age and donor type. The primary end point was development of grade II-IV GvHD. The cumulative incidence of grade II-IV GvHD was 50% in the observation arm and 33% in the treatment arm (P=0.005). However, grade III-IV GvHD was comparable (13% vs. 10%, respectively; P=0.6), and this was true for sibling and alternative donor transplants. Moderate/severe chronic GvHD was also comparable (17% vs. 9%). In multivariate analysis, an early interval between transplant and randomization (
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