Tacrolimus/Sirolimus vs Tacrolimus/Methotrexate as GVHD Prophylaxis After Matched, Related Donor Allogeneic HCT

Publication Type
Journal Article
Year of Publication
2014
Authors
Cutler, C; Logan, B; Nakamura, R; Johnston, L; Choi, S; Porter, D; Hogan, WJ; Pasquini, M; MacMillan, ML; Hsu, JW; Waller, EK; Grupp, S; McCarthy, P; Wu, J; Hu, ZH; Carter, SL; Horowitz, MM; Antin, JH
Secondary
Blood
Volume
124
Start Page
1372
Pagination
1372-1377
Date Published
08/2014
Keywords
Allografts; Disease-Free Survival; Follow-Up Studies; Graft vs Host Disease; Hematopoietic Stem Cell Transplantation; Humans; Immunosuppressive Agents; Methotrexate; sirolimus; Stomatitis; Survival Rate; Tacrolimus; Time Factors
Abstract
{Grades 2-4 acute graft-versus-host disease (GVHD) occurs in approximately 35% of matched, related donor (MRD) allogeneic hematopoietic cell transplantation (HCT) recipients. We sought to determine if the combination of tacrolimus and sirolimus (Tac/Sir) was more effective than tacrolimus and methotrexate (Tac/Mtx) in preventing acute GVHD and early mortality after allogeneic MRD HCT in a phase 3, multicenter trial. The primary end point of the trial was to compare 114-day grades 2-4 acute GVHD-free survival using an intention-to-treat analysis of 304 randomized subjects. There was no difference in the probability of day 114 grades 2-4 acute GVHD-free survival (67% vs 62%
URL
http://www.ncbi.nlm.nih.gov/pubmed/24982504