Document Detail

Graft-versus-host disease prophylaxis with everolimus and tacrolimus is associated with a high incidence of sinusoidal obstruction syndrome and microangiopathy: results of the EVTAC trial.
MedLine Citation:
PMID:  19135948     Owner:  NLM     Status:  MEDLINE    
A calcineurin inhibitor combined with methotrexate is the standard prophylaxis for graft-versus-host disease (GVHD) after allogeneic hematopoietic stem cell transplantation (HSCT). Everolimus, a derivative of sirolimus, seems to mediate antileukemia effects. We report on a combination of everolimus and tacrolimus in 24 patients (median age, 62 years) with either myelodysplastic syndrome (MDS; n = 17) or acute myeloid leukemia (AML; n = 7) undergoing intensive conditioning followed by HSCT from related (n = 4) or unrelated (n = 20) donors. All patients engrafted, and only 1 patient experienced grade IV mucositis. Nine patients (37%) developed acute grade II-IV GVHD, and 11 of 17 evaluable patients (64%) developed chronic extensive GVHD. Transplantation-associated microangiopathy (TMA) occurred in 7 patients (29%), with 2 cases of acute renal failure. The study was terminated prematurely because an additional 6 patients (25%) developed sinusoidal obstruction syndrome (SOS), which was fatal in 2 cases. With a median follow-up of 26 months, the 2-year overall survival rate was 47%. Although this new combination appears to be effective as a prophylactic regimen for acute GVHD, the incidence of TMA and SOS is considerably higher than seen with other regimens.
Uwe Platzbecker; Malte von Bonin; Eray Goekkurt; Jörgen Radke; Marc Binder; Alexander Kiani; Jan Stoehlmacher; Johannes Schetelig; Christian Thiede; Gerhard Ehninger; Martin Bornhäuser
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Publication Detail:
Type:  Clinical Trial, Phase II; Journal Article    
Journal Detail:
Title:  Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation     Volume:  15     ISSN:  1523-6536     ISO Abbreviation:  Biol. Blood Marrow Transplant.     Publication Date:  2009 Jan 
Date Detail:
Created Date:  2009-01-12     Completed Date:  2009-02-27     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9600628     Medline TA:  Biol Blood Marrow Transplant     Country:  United States    
Other Details:
Languages:  eng     Pagination:  101-8     Citation Subset:  IM    
Medizinische Klinik und Poliklinik I, Universitätsklinikum Carl Gustav Carus, Dresden, Germany.
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MeSH Terms
Anemia, Hemolytic / chemically induced*
Graft vs Host Disease / drug therapy,  prevention & control*
Hematopoietic Stem Cell Transplantation / adverse effects,  methods*,  mortality
Hepatic Veno-Occlusive Disease / chemically induced*
Leukemia, Myeloid, Acute / complications,  therapy
Middle Aged
Myelodysplastic Syndromes / complications,  therapy
Sirolimus / adverse effects,  analogs & derivatives*
Survival Rate
Tacrolimus / adverse effects*
Transplantation, Homologous
Reg. No./Substance:
109581-93-3/Tacrolimus; 159351-69-6/everolimus; 53123-88-9/Sirolimus

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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