Journal
BIOLOGY OF BLOOD AND MARROW TRANSPLANTATION
Volume 14, Issue 5, Pages 531-537Publisher
ELSEVIER SCIENCE INC
DOI: 10.1016/j.bbmt.2008.02.009
Keywords
sirolimus; graft-versus-host disease; hematopoietic cell transplantation
Categories
Funding
- NCI NIH HHS [P01 CA018029-32, P01 CA018029, P30 CA015704, P30 CA015704-34, CA 15704, CA18029] Funding Source: Medline
- NHLBI NIH HHS [P01 HL036444-27, HL36444, P01 HL036444] Funding Source: Medline
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In 2 consecutive prospective clinical trials, we evaluated the efficacy of sirolimus together with a calcineurin inhibitor (cyclosporine or tacrolimus) and low-dose methotrexate for prevention of graft-versus-host disease (GVHD) after unrelated hematopoietic cell transplantation (HCT). Nine patients received sirolimus with cyclosporine, and 17 received sirolimus with tacrolimus. The incidence of grade II-IV GVHD was 77%, with the median onset at day 7 after HCT. Because of toxicity, administration of sirolimus was discontinued earlier than planned in 11 patients, but after the onset of GVHD. Three patients developed renal failure requiring hemodialysis. Accrual in both studies was terminated because of lack of efficacy. In these studies, the addition of sirolimus to regimens containing a calcineurin inhibitor and methotrexate appeared to cause toxicity and provided no detectable improvement in preventing GVHD. (C) 2008 American Society for Blood and Marrow Transplantation.
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