Switch to
| Predicate | Object |
|---|---|
| rdf:type | |
| lifeskim:mentions | |
| pubmed:issue |
7
|
| pubmed:dateCreated |
1998-10-19
|
| pubmed:abstractText |
Ninety-five patients undergoing an allogeneic bone marrow transplant (BMT) and developing acute graft-versus-host disease (aGvHD) were randomized to receive low-dose intravenous 6-methylprednisolone (6MPred; 2 mg/kg /d; n = 47) or high-dose 6MPred (10 mg/kg/d; n = 48) for 5 days, with subsequent tapering doses. On day 5 patients not responding or progressing on low-dose 6MPred could be switched to high-dose 6MPred. All patients, aged 1 to 55 years, were recipients of unmanipulated BMT from HLA identical sibling donors. Patients were stratified at randomization for age (</>/= 20 years), disease (acute leukemia, chronic myeloid leukemia [CML], nonneoplastic disease), disease status (early/advanced), and GvHD prophylaxis (cyclosporin/cyclosporin + methotrexate). Primary endpoints were response to treatment and evolution of aGvHD to grade III-IV. Secondary endpoints were cytomegalovirus (CMV) infections, transplant-related mortality (TRM), and relapse. The median interval between BMT and treatment was 12 days (6 to 43). Results in the two groups (2 v 10 mg/kg) were as follows: response of aGvHD 68% versus 71% (P = .9), evolution to aGvHD grade III-IV 17% versus 20% (P = . 6), CMV infections 55% versus 60% (P = .7), 3-year actuarial TRM 28% versus 32% (P = .7), relapse 17% versus 7% (P = .1). The actuarial survival at 3 years was 63% versus 62% (P = .9) with a median follow up of 580 and 778 days. On day 5 of therapy, 26 patients assigned to low-dose (2 mg/kg) 6MPred were switched to a higher dose of 6MPred because of no response or progression. Their actuarial TRM was 46%, which is significantly higher than TRM of patients who responded on 2 mg/kg and continued with tapering doses (TRM = 16%, P = .007). In conclusion, early treatment of acute GvHD with 6MPred 10 mg/kg/d does not improve the response rate as compared with 2 mg/kg/d, nor does it prevent evolution to aGvHD grade III-IV. CMV infections, TRM, and survival were also comparable. A group of patients at high risk of TRM can be identified after 5 days of treatment with 6MPred 2 mg/kg and could be eligible for alternative forms of therapy.
|
| pubmed:language |
eng
|
| pubmed:journal | |
| pubmed:citationSubset |
AIM
|
| pubmed:chemical | |
| pubmed:status |
MEDLINE
|
| pubmed:month |
Oct
|
| pubmed:issn |
0006-4971
|
| pubmed:author |
pubmed-author:AlessandrinoPP,
pubmed-author:ArceseWW,
pubmed-author:BacigalupoAA,
pubmed-author:BosiAA,
pubmed-author:DiniGG,
pubmed-author:FaldaMM,
pubmed-author:GiorgianiGG,
pubmed-author:IoriA PAP,
pubmed-author:LocasciulliAA,
pubmed-author:LocatelliFF,
pubmed-author:MajolinoII,
pubmed-author:MinieroRR,
pubmed-author:RotoliBB,
pubmed-author:SciméRR,
pubmed-author:UderzoCC,
pubmed-author:Van LintM TMT
|
| pubmed:issnType |
Print
|
| pubmed:day |
1
|
| pubmed:volume |
92
|
| pubmed:owner |
NLM
|
| pubmed:authorsComplete |
Y
|
| pubmed:pagination |
2288-93
|
| pubmed:dateRevised |
2006-11-15
|
| pubmed:meshHeading |
pubmed-meshheading:9746766-Actuarial Analysis,
pubmed-meshheading:9746766-Acute Disease,
pubmed-meshheading:9746766-Adolescent,
pubmed-meshheading:9746766-Adult,
pubmed-meshheading:9746766-Bone Marrow Transplantation,
pubmed-meshheading:9746766-Cause of Death,
pubmed-meshheading:9746766-Child,
pubmed-meshheading:9746766-Child, Preschool,
pubmed-meshheading:9746766-Cytomegalovirus Infections,
pubmed-meshheading:9746766-Dose-Response Relationship, Drug,
pubmed-meshheading:9746766-Female,
pubmed-meshheading:9746766-Graft vs Host Disease,
pubmed-meshheading:9746766-Hematologic Neoplasms,
pubmed-meshheading:9746766-Histocompatibility,
pubmed-meshheading:9746766-Humans,
pubmed-meshheading:9746766-Hyperglycemia,
pubmed-meshheading:9746766-Hypertension,
pubmed-meshheading:9746766-Immunosuppressive Agents,
pubmed-meshheading:9746766-Infant,
pubmed-meshheading:9746766-Infection,
pubmed-meshheading:9746766-Italy,
pubmed-meshheading:9746766-Male,
pubmed-meshheading:9746766-Methylprednisolone,
pubmed-meshheading:9746766-Middle Aged,
pubmed-meshheading:9746766-Nuclear Family,
pubmed-meshheading:9746766-Prospective Studies,
pubmed-meshheading:9746766-Recurrence,
pubmed-meshheading:9746766-Survival Analysis,
pubmed-meshheading:9746766-Tissue Donors,
pubmed-meshheading:9746766-Transplantation, Homologous,
pubmed-meshheading:9746766-Transplantation Conditioning,
pubmed-meshheading:9746766-Treatment Outcome
|
| pubmed:year |
1998
|
| pubmed:articleTitle |
Early treatment of acute graft-versus-host disease with high- or low-dose 6-methylprednisolone: a multicenter randomized trial from the Italian Group for Bone Marrow Transplantation.
|
| pubmed:affiliation |
Divisione Ematologial, Ospedale San Martino, Genova; Clinica Pediatrica, Milano, Italy.
|
| pubmed:publicationType |
Journal Article,
Clinical Trial,
Comparative Study,
Randomized Controlled Trial,
Research Support, Non-U.S. Gov't,
Multicenter Study
|