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Titolo:
FK506 (TACROLIMUS) MONOTHERAPY FOR PREVENTION OF GRAFT-VERSUS-HOST DISEASE AFTER HISTOCOMPATIBLE SIBLING ALLOGENEIC BONE-MARROW TRANSPLANTATION
Autore:
FAY JW; WINGARD JR; ANTIN JH; COLLINS RH; PINEIRO LA; BLAZAR BR; SARAL R; BIERER BE; PRZEPIORKA D; FITZSIMMONS WE; MAHER RM; WEISDORF DJ;
Indirizzi:
BAYLOR UNIV,MED CTR,CHARLES A SAMMONS CANC CTR,3500 GASTON AVE,SAMMONS TOWER,SUITE 605 DALLAS TX 75146 UNIV MINNESOTA MINNEAPOLIS MN 55455 EMORY UNIV ATLANTA GA 30322 HARVARD UNIV,BRIGHAM & WOMENS HOSP BOSTON MA 02115 MD ANDERSON HOSP HOUSTON TX 00000 FUJISAWA USA DEERFIELD IL 00000
Titolo Testata:
Blood
fascicolo: 8, volume: 87, anno: 1996,
pagine: 3514 - 3519
SICI:
0006-4971(1996)87:8<3514:F(MFPO>2.0.ZU;2-H
Fonte:
ISI
Lingua:
ENG
Soggetto:
HEMOLYTIC-UREMIC SYNDROME; TOTAL-BODY IRRADIATION; FK-506; CYCLOSPORINE; METHOTREXATE; PROPHYLAXIS; LEUKEMIA; TRIAL; ASSAY; RATS;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Science Citation Index Expanded
Citazioni:
48
Recensione:
Indirizzi per estratti:
Citazione:
J.W. Fay et al., "FK506 (TACROLIMUS) MONOTHERAPY FOR PREVENTION OF GRAFT-VERSUS-HOST DISEASE AFTER HISTOCOMPATIBLE SIBLING ALLOGENEIC BONE-MARROW TRANSPLANTATION", Blood, 87(8), 1996, pp. 3514-3519

Abstract

FK506 (Tacrolimus) is an immunosuppressive drug that blocks the activation of antigen-specific T lymphocytes, a major component in the pathogenesis of graft-versus-host disease (GVHD). This study was designed to obtain first estimates of the safety and efficacy of FK506 monotherapy in the prevention of GVHD following HLA-identical sibling marrow transplantation. Additionally, a subset of patients was studied to define the pharmacokinetic profile of FK506. Twenty-seven adult patients with leukemia or myelodysplasia received FK506 starting the day before transplant at a dose of 0.04 mg/kg/d by continuous intravenous infusion. When clinically possible, FK506 was given orally in two divided doses starting at five times the daily intravenous dose. FK506 doses wereadjusted to target a steady state or trough blood level between 10 to30 ng/mL. These patients were followed for 6 months posttransplant. All patients had sustained marrow engraftment. Frequently noted adverseevents included reversible renal dysfunction, diarrhea, fever, nausea, vomiting, and headache. Most patients required FK506 dose reductionsassociated with elevated serum creatinine. Two (7%) patients relapsed, one of whom died of the disease within the 6-month study period. A second patient died due to pulmonary mucor. Whole blood pharmacokineticparameters indicated a half-life of 18.2 +/- 12.1 hours; volume of distribution of 1.67 +/- 1.02 L/kg; clearance of 71 +/- 34 mL/h/kg; and bioavailability of 32 +/- 24%. Eleven of 27 (41%) patients developed grade II to IV acute GVHD, including 10 grade II and one grade III. Sixof 24 (25%) evaluable patients developed chronic GVHD. These data indicate that FK506 monotherapy has activity in preventing GVHD. Further studies of FK506 with lower doses to improve tolerability and in combination with other immunosuppressants to augment efficacy are warranted. (C) 1996 by The American Society of Hematology.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 05/07/20 alle ore 21:35:25