FK506 in combination with methotrexate for the prevention of graft-versus-host disease after marrow transplantation from matched unrelated donors.



Blood, 1996; 88 (9) doi:

Authors: Nash R A, Piñeiro L A, Storb R, Deeg H J, Fitzsimmons W E et al.(9)

Affiliation: Fred Hutchinson Cancer Research Center, United States

Sample size: 25

Abstract: The safety and potential efficacy of FK506 in combination with a short course of methotrexate (MTX) for the prevention of acute graft-versus-host disease (GVHD) after marrow transplantation from HLA-matched unrelated donors was evaluated in a single-arm Phase II study conducted at two centers. Forty-three patients, 15 to 54 (median 41) years of age, were transplanted for hematologic malignancies. Thirty-seven of 43 evaluable patients had evidence of sustained marrow engraftment. Five patients died before day 17 after transplantation. The median time to an absolute neutrophil count of > 0.5 x 10(5)/L was 21 (range, 14 to 30) days. Nephrotoxicity (serum creatinine concentration > 2 mg/dL or doubling of baseline) occurred in 32 patients (74% cumulative incidence during the first 100 days after transplant). Other adverse effects included hypertension (n = 27), hyperglycemia (n = 27), neurotoxicity (n = 9) and thrombotic thrombocytopenic purpura (n = 2). Severe veno-occlusive disease of the liver occurred in 9 (21%) of the 43 patients. Eighteen patients (42%) developed grades II to IV acute GVHD and five (12%) developed grades III to IV acute GVHD. Twelve of 25 evaluable patients developed extensive chronic GVHD within 1 year of marrow transplantation resulting in an estimate of the probability of developing this complication of 48%. The cumulative incidence of transplant-related mortality during the first 100 days was 37%. Kaplan-Meier estimates of disease-free survival at 2 years for good-risk, poor-risk, and all patients were 65%, 4%, and 32%, respectively. FK506 in combination with a short course of MTX appears active in preventing acute GVHD after marrow transplantation from unrelated donors. Further studies comparing the combination of FK506 and MTX with cyclosporine and MTX for the prevention of acute GVHD are warranted.












Cited by:
Choi Sung W, Stiff Patrick, et al. 2012. "TNF-inhibition with etanercept for graft-versus-host disease prevention in high-risk HCT: lower TNFR1 levels correlate with better outcomes." Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation
Horan John T, Logan Brent R, et al. 2011. "Reducing the risk for transplantation-related mortality after allogeneic hematopoietic cell transplantation: how much progress has been made?" Journal of clinical oncology : official journal of the American Society of Clinical Oncology
Doney Kristine, Gooley Ted A, et al. 2011. "Allogeneic hematopoietic cell transplantation with full-intensity conditioning for adult acute lymphoblastic leukemia: results from a single center, 1998-2006." Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation
Lin Yu-Feng, Lairson David R, et al. 2010. "The costs and cost-effectiveness of allogeneic peripheral blood stem cell transplantation versus bone marrow transplantation in pediatric patients with acute leukemia." Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation
Garcia-Vidal Carol, Upton Arlo, et al. 2008. "Epidemiology of invasive mold infections in allogeneic stem cell transplant recipients: biological risk factors for infection according to time after transplantation." Clinical infectious diseases : an official publication of the Infectious Diseases Society of America


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