Prophylaxis with Sirolimus and Tacrolimus ± Antithymocyte Globulin Reduces the Risk of Acute Graft-versus-Host Disease without an Overall Survival Benefit Following Allogeneic Stem Cell Transplantation

Biology of Blood and Marrow Transplantation

Volumn 17, Issue 6, 2011, Pages 916-922

  Rosenbeck, Lindsay L ^a,b   Kiel, Patrick J ^a,b   Kalsekar, Iftekhar ^c   Vargo, Craig ^a   Baute, John ^b   Sullivan, Cheryl K ^b   Wood, Lisa ^b   Abdelqader, Sahar ^b   Schwartz, Jennifer ^a,b   Srivastava, Shivani ^a,b   Abonour, Rafat ^a,b   Robertson, Michael J ^a,b   Nelson, Robert P ^a,b   Cornetta, Kenneth ^a,b   Fausel, Christopher A ^a,b   Farag, Sherif S ^a,b  

^a INDIANA UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b INDIANA UNIVERSITY SCHOOL OF MEDICINE   (United States)

^c BUTLER UNIVERSITY   (United States)

Author keywords

Graft versus host disease; Sinusoidal obstructive syndrome; Sirolimus; Stem cell transplant; Tacrolimus

Indexed keywords

ACICLOVIR; CIPROFLOXACIN; COTRIMOXAZOLE; CYCLOSPORIN; FLUCONAZOLE; METHOTREXATE; PENTAMIDINE; RAPAMYCIN; RECOMBINANT GRANULOCYTE COLONY STIMULATING FACTOR; TACROLIMUS; THYMOCYTE ANTIBODY;

ADULT; ALLOGENEIC STEM CELL TRANSPLANTATION; ALLOTRANSPLANTATION; ARTICLE; BONE MARROW TRANSPLANTATION; CONTINUOUS INFUSION; FEMALE; GRAFT VERSUS HOST REACTION; HEMATOLOGIC MALIGNANCY; HUMAN; INTERSTITIAL PNEUMONIA; MAJOR CLINICAL STUDY; MALE; OVERALL SURVIVAL; THROMBOTIC THROMBOCYTOPENIC PURPURA;

ADULT; ANTILYMPHOCYTE SERUM; CALCINEURIN; CYCLOSPORINE; FEMALE; GRAFT VS HOST DISEASE; HEMATOLOGIC NEOPLASMS; HEMATOPOIETIC STEM CELL TRANSPLANTATION; HUMANS; IMMUNOSUPPRESSIVE AGENTS; LUNG DISEASES, INTERSTITIAL; MALE; METHOTREXATE; MIDDLE AGED; RETROSPECTIVE STUDIES; RISK FACTORS; SIROLIMUS; SURVIVAL ANALYSIS; TACROLIMUS; THROMBOTIC MICROANGIOPATHIES; TRANSPLANTATION CONDITIONING; TRANSPLANTATION, HOMOLOGOUS; YOUNG ADULT;

EID: 79956053688     PISSN: 10838791     EISSN: 15236536     Source Type: Journal    
DOI: 10.1016/j.bbmt.2010.09.017     Document Type: Article

References (34)

1. Storb R., Deeg H.J., Whitehead J., et al. Methotrexate and cyclosporine compared with cyclosporine alone for prophylaxis of acute graft versus host disease in marrow transplantation in for leukemia. N Engl J Med 1986, 314:729-735.
2. Storb R., Deeg H.J., Pepe M., et al. Methotrexate and cyclosporine versus cyclosporine alone for prophylaxis of graft-versus-host disease in patients given HLA-identical marrow grafts for leukemia: long-term follow up of a controlled trial. Blood 1989, 73:1729-1734.
3. Weisdorf D.J., Anasetti C., Antin J.H., et al. Allogeneic bone marrow transplantation for chronic myelogenous leukemia: comparative analysis of unrelated versus match sibling donor transplantation. Blood 2002, 99:1971-1977.
4. Nash R.A., Antin J.H., Karanes C., et al. Phase 3 study comparing methotrexate and tacrolimus with methotrexate and cyclosporine for prophylaxis of acute graft-versus-host disease after marrow transplantation from unrelated donors. Blood 2000, 96:2062-2068.
5. Ratanatharathorn V., Nash R.A., Przepiorka D., et al. 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. Blood 1998, 92:2303-2314.
6. Sehgal S.N. Rapamune (RAPA, rapamycin, sirolimus): mechanism of action immunosuppressive effect results from blockade of signal transduction and inhibition of cell cycle progression. Clin Biochem 1998, 31:335-340.
7. Powell J.D., Lerner C.G., Schwartz R.H. Inhibition of cell cycle progression by rapamycin induces T cell clonal anergy even in the presence of costimulation. J Immunol 1999, 162:2775-2784.
8. Wekerle T. T-regulatory cells-what relationship with immunosuppressive agents?. Transplant Proc 2008, 40:S13-S16.
9. Powell J.D., Fitzhugh C., Kang E.M., Hsieh M., Schwartz R.H., Tisdale J.F. Low-dose radiation plus rapamycin promotes long-term bone marrow chimerism. Transplantation 2005, 80:1541-1545.
10. Hsieh M.M., Kang E.M., Fitzhugh C.D., et al. Allogeneic hematopoietic stem-cell transplantation for sickle cell disease. N Engl J Med 2009, 361:2309-2317.
11. Wu T., Sozen H., Luo N., et al. Rapamycin and T cell costimulatory blockade as post-transplant treatment promote fully MHC-mismatched allogeneic bone marrow engraftment under irradiation-free conditioning therapy. Bone Marrow Transplant 2002, 29:949-956.
12. Flechner S.M. Reviewing the evidence for de novo immunosuppression with sirolimus. Transplant Proc 2008, 40(10 Suppl):S25-S28.
13. Cutler C., Ho V., Koreth J., et al. Extended follow-up of methotrexate-free immunosuppression using sirolimus and tacrolimus in related and unrelated donor peripheral blood stem cell transplantation. Blood 2007, 109:3108-3114.
14. Cutler C., Antin J.H. Sirolimus for GVHD prophylaxis in allogeneic stem cell transplantation. Bone Marrow Transplant 2004, 34:471-476.
15. Armand P., Gannamaneni S., Kim H., et al. Improved survival in lymphoma patients recieving sirolimus for graft-versus-host disease prophylaxis after allogeneic hematopoietic stem-cell transplantation with reduced-intensity conditioning. J Clin Oncol 2008, 26:5756-5774.
16. Ho V., Aldridge J., Kim H., et al. Comparison of tacrolimus and sirolimus (Tac/Sir) versus tacrolimus, sirolimus, and mini-methotrexate (Tac/Sir/MTX) as acute graft-versus-host disease prophylaxis after reduced-intensity conditioning allogeneic peripheral blood stem cell transplantation. Biol Blood Marrow Transplant 2009, 15:844-850.
17. Cutler C., Henry N.L., Magee C., et al. Sirolimus and thrombotic microangiopathy after allogeneic hematopoietic stem cell transplantation. Biol Blood Marrow Transplant 2005, 11:551-557.
18. Pham P.T., Pham P.C., Danovitch G.M., et al. Sirolimus-associated pulmonary toxicity. Transplantation 2004, 77:1215-1220.
19. Garrean S., Massad M.G., Tshibaka M., Hanhan Z., Caines A.E., Benedetti E. Sirolimus-associated interstitial pneumonitis in solid organ transplant recipients. Clin Transplant 2005, 19:698-703.
20. McDonald G.B., Sharma P., Matthews D.E., Shulman H.M., Thomas E.D. Venocclusive disease of the liver after bone marrow transplantation: diagnosis, incidence, and predisposing factors. Hepatology 1984, 4:116-122.
21. Cutler C., Stevenson K., Kim H.T., et al. Sirolimus is associated with veno-occlusive disease of the liver after myeloablative allogeneic stem cell transplantation. Blood 2008, 112:4425-4431.
22. Boeckh M., Myerson D., Bowden R.A. Early detection and treatment of cytomegalovirus infections in marrow transplant patients: methodological aspects and implications for therapeutic interventions. Bone Marrow Transplant 1994, 14(Suppl 4):S66-S70.
23. Przepiorka D., Weisdorf D., Martin P., et al. 1994 Consensus conference on acute GVHD grading. Bone Marrow Transplant 1995, 15:825-882.
24. Shulman H.M., Sullivan K.M., Weiden P.L., et al. Chronic graft-versus-host syndrome in man: a long term clinicopathologic study of 20 Seattle patients. Am J Med 1980, 69:204-217.
25. Kaplan E., Meier P. Nonparametric estimation from incomplete observations. J Am Stat Assoc 1958, 53:457-481.
26. Mantel N. Evaluation of survival data and two new rank order statistics arising in its consideration. Cancer Chemother Rep 1966, 50:163-170.
27. Cox D.R. Regression models and life-tables. J R Stat Soc B 1972, 34:187-220.
28. Rodriguez R., Nakamura R., Palmer J.M., et al. A phase II pilot study of tacrolimus/sirolimus GVHD prophylaxis for sibling donor hematopoietic stem cell transplant using three conditioning regimens. Blood 2009, 115:1098-1105.
29. Ayuk F., Diyachenko G., Zabelina T., et al. Anti-thymocyte globulin overcomes the negative impact of HLA mismatching in transplantation from unrelated donors. Exp Hematol 2008, 36:1047-1054.
30. Bacigalupo A., Lamparelli T., Barisione G., et al. Thymoglobulin prevents chronic graft-versus-host disease, chronic lung dysfunction, and late transplant-related mortality: long-term follow-up of a randomized trial in patients undergoing unrelated donor transplantation. Biol Blood Marrow Transplant 2006, 12:560-565.
31. Bacigalupo A., Lamparelli T., Bruzzi P., et al. Antithymocyte globulin for graft versus host disease prophylaxis in transplants from unrelated donors: 2 randomized studies from Gruppo Italiano Trapianti Midollo Osseo (GITMO). Blood 2001, 98:2942-2947.
32. Matter C.M., Rozenberg I., Jaschka A., et al. Effects of tacrolimus or sirolimus on proliferation of vascular smooth muscle and endothelial cells. J Cardiovasc Pharmacol 2006, 48:286-292.
33. Miriuka S.G., Rao V., Peterson M., et al. mTOR inhibition induces endothelial progenitor cell death. Am J Transplant 2006, 6:2069-2079.
34. Marks A.R. Rapamycin: signaling in vascular smooth muscle. Transplant Proc 2003, 65:231S-233S.