Switch to
| Predicate | Object |
|---|---|
| rdf:type | |
| lifeskim:mentions | |
| pubmed:issue |
7
|
| pubmed:dateCreated |
1998-10-19
|
| pubmed:abstractText |
We report the results of a phase III open-label, randomized, multicenter trial comparing tacrolimus/methotrexate to cyclosporine/methotrexate for graft-versus-host disease (GVHD) prophylaxis after HLA-identical sibling marrow transplantation in patients with hematologic malignancy. The primary objective of this study was to compare the incidence of moderate to severe (grade II-IV) acute GVHD. Secondary objectives were to compare the relapse rate, disease-free survival, overall survival, and the incidence of chronic GVHD. Patients were stratified according to age (<40 v >/=40) and for male recipients of a marrow graft from an alloimmunized female. There was a significantly greater proportion of patients with advanced disease randomized to tacrolimus arm (P = . 02). The incidence of grade II-IV acute GVHD was significantly lower in patients who received tacrolimus than patients in the cyclosporine group (31.9% and 44.4%, respectively; P = .01). The incidence of grade III-IV acute GVHD was similar, 17.1% in cyclosporine group and 13.3% in the tacrolimus group. There was no difference in the incidence of chronic GVHD between the tacrolimus and the cyclosporine group (55.9% and 49.4%, respectively; P = .8). However, there was a significantly higher proportion of patients in the cyclosporine group who had clinical extensive chronic GVHD (P = . 03). The relapse rates of the two groups were similar. The patients in the cyclosporine arm had a significantly better 2-year disease-free survival and overall survival than patients in the tacrolimus arm, 50.4% versus 40.5% (P = .01) and 57.2% versus 46.9% (P = .02), respectively. The significant difference in the overall and disease-free survival was largely the result of the patients with advanced disease, 24.8% with tacrolimus versus 41.7% with cyclosporine (P = .006) and 20.4% with tacrolimus versus 28% with cyclosporine (P = .007), respectively. There was a higher frequency of deaths from regimen-related toxicity in patients with advanced disease who received tacrolimus. There was no difference in the disease-free and overall survival in patients with nonadvanced disease. These results show the superiority of tacrolimus/methotrexate over cyclosporine/methotrexate in the prevention of grade II-IV acute GVHD with no difference in disease-free or overall survival in patients with nonadvanced disease. The survival disadvantage in advanced disease patients receiving tacrolimus warrants further investigation.
|
| pubmed:language |
eng
|
| pubmed:journal | |
| pubmed:citationSubset |
AIM
|
| pubmed:chemical | |
| pubmed:status |
MEDLINE
|
| pubmed:month |
Oct
|
| pubmed:issn |
0006-4971
|
| pubmed:author |
pubmed-author:AntinJ HJH,
pubmed-author:AvalosBB,
pubmed-author:BuellD NDN,
pubmed-author:ChristiansenN PNP,
pubmed-author:DevineS MSM,
pubmed-author:FayJ WJW,
pubmed-author:FitzsimmonsW EWE,
pubmed-author:HerzigR HRH,
pubmed-author:KaranesCC,
pubmed-author:KleinJ LJL,
pubmed-author:LitzowM RMR,
pubmed-author:LongoW LWL,
pubmed-author:MaherR MRM,
pubmed-author:NademaneeAA,
pubmed-author:NashR ARA,
pubmed-author:PetersenF BFB,
pubmed-author:PrzepiorkaDD,
pubmed-author:RatanatharathornVV,
pubmed-author:StorbRR,
pubmed-author:WeisdorfDD,
pubmed-author:WingardJ RJR,
pubmed-author:WolffS NSN,
pubmed-author:van der JagtRR
|
| pubmed:issnType |
Print
|
| pubmed:day |
1
|
| pubmed:volume |
92
|
| pubmed:owner |
NLM
|
| pubmed:authorsComplete |
Y
|
| pubmed:pagination |
2303-14
|
| pubmed:dateRevised |
2006-11-15
|
| pubmed:meshHeading |
pubmed-meshheading:9746768-Adolescent,
pubmed-meshheading:9746768-Adult,
pubmed-meshheading:9746768-Bone Marrow Transplantation,
pubmed-meshheading:9746768-Child,
pubmed-meshheading:9746768-Cyclosporine,
pubmed-meshheading:9746768-Disease-Free Survival,
pubmed-meshheading:9746768-Drug Therapy, Combination,
pubmed-meshheading:9746768-Female,
pubmed-meshheading:9746768-Graft vs Host Disease,
pubmed-meshheading:9746768-Hematologic Neoplasms,
pubmed-meshheading:9746768-Histocompatibility,
pubmed-meshheading:9746768-Humans,
pubmed-meshheading:9746768-Hyperglycemia,
pubmed-meshheading:9746768-Hypertension,
pubmed-meshheading:9746768-Immunosuppressive Agents,
pubmed-meshheading:9746768-Incidence,
pubmed-meshheading:9746768-Male,
pubmed-meshheading:9746768-Methotrexate,
pubmed-meshheading:9746768-Middle Aged,
pubmed-meshheading:9746768-Nuclear Family,
pubmed-meshheading:9746768-Recurrence,
pubmed-meshheading:9746768-Survival Analysis,
pubmed-meshheading:9746768-Tacrolimus,
pubmed-meshheading:9746768-Tissue Donors,
pubmed-meshheading:9746768-Transplantation, Homologous,
pubmed-meshheading:9746768-Treatment Outcome
|
| pubmed:year |
1998
|
| pubmed:articleTitle |
Phase III study comparing methotrexate and tacrolimus (prograf, FK506) with methotrexate and cyclosporine for graft-versus-host disease prophylaxis after HLA-identical sibling bone marrow transplantation.
|
| pubmed:affiliation |
University of Michigan, Ann Arbor; Fred Hutchinson Cancer Research Center, Seattle, WA, USA. vratanat@umich.edu
|
| pubmed:publicationType |
Journal Article,
Clinical Trial,
Comparative Study,
Randomized Controlled Trial,
Research Support, Non-U.S. Gov't,
Clinical Trial, Phase III
|