Steroid treatment of acute graft-versus-host disease grade I: A randomized trial

Patrizia Chiusolo, Simona Sica, Andrea Bacigalupo, Giuseppe Milone, Alessandra Cupri, Antonio Severino, Franca Fagioli, Massimo Berger, Stella Santarone, Sonia Mammoliti, Roberto Sorasio, Daniela Massi, Maria Teresa Van Lint, Anna Maria Raiola, Francesca Gualandi, Carmine Selleri, Maria Pia Sormani, Alessio Signori, Antonio Risitano, Francesca Bonifazi

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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 (
Original languageEnglish
Pages (from-to)2125-2133
Number of pages9
JournalHaematologica
Volume102
DOIs
Publication statusPublished - 2017

Keywords

  • Hematology

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