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

Aug-14

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:
<p>{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%</p>

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