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Tacrolimus/sirolimus vs tacrolimus/methotrexate as GVHD prophylaxis after matched, related donor allogeneic HCT.

TitleTacrolimus/sirolimus vs tacrolimus/methotrexate as GVHD prophylaxis after matched, related donor allogeneic HCT.
Publication TypeJournal Article
Year of Publication2014
AuthorsCutler, 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, Z-H, Carter, SL, Horowitz, MM, Antin, JH
JournalBlood
Volume124
Issue8
Pagination1372-7
Date Published2014 Aug 21
ISSN1528-0020
KeywordsAdolescent, Adult, Allografts, Disease-Free Survival, Female, Follow-Up Studies, Graft vs Host Disease, Hematopoietic Stem Cell Transplantation, Humans, Immunosuppressive Agents, Male, Methotrexate, Middle Aged, 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%, P = .38). Grades 2-4 GVHD was similar in the Tac/Sir and Tac/Mtx arms (26% vs 34%, P = .48). Neutrophil and platelet engraftment were more rapid in the Tac/Sir arm (14 vs 16 days, P

DOI10.1182/blood-2014-04-567164
Alternate JournalBlood
PubMed ID24982504
PubMed Central IDPMC4141519
Grant ListU10 HL069294 / HL / NHLBI NIH HHS / United States
UG1 HL069286 / HL / NHLBI NIH HHS / United States
U10 HL069290 / HL / NHLBI NIH HHS / United States
U10 HL069278 / HL / NHLBI NIH HHS / United States
U10 HL069301 / HL / NHLBI NIH HHS / United States
U10 HL069330 / HL / NHLBI NIH HHS / United States
U10 HL069291 / HL / NHLBI NIH HHS / United States
U10 HL109137 / HL / NHLBI NIH HHS / United States
U01 HL069294 / HL / NHLBI NIH HHS / United States
U10 HL109322 / HL / NHLBI NIH HHS / United States
P01 CA049605 / CA / NCI NIH HHS / United States
U24 CA076518 / CA / NCI NIH HHS / United States
U10 HL069286 / HL / NHLBI NIH HHS / United States
U01HL069294 / HL / NHLBI NIH HHS / United States
UG1 HL069278 / HL / NHLBI NIH HHS / United States
U10 HL069249 / HL / NHLBI NIH HHS / United States
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