Tacrolimus/Sirolimus vs Tacrolimus/Methotrexate as GVHD Prophylaxis After Matched, Related Donor Allogeneic HCT
08/2014
Journal Article
Authors:
Cutler, C.;
Logan, B.;
Nakamura, R.;
Johnston, L.;
Choi, S.;
Porter, D.;
Hogan, W.J.;
Pasquini, M.;
MacMillan, M.L.;
Hsu, J.W.;
Waller, E.K.;
Grupp, S.;
McCarthy, P.;
Wu, J.;
Hu, Z.H.;
Carter, S.L.;
Horowitz, M.M.;
Antin, J.H.
Secondary:
Blood
Volume:
124
Pagination:
1372-1377
URL:
http://www.ncbi.nlm.nih.gov/pubmed/24982504
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%
