The combination of sirolimus plus tacrolimus improves outcome after reduced-intensity conditioning, unrelated donor hematopoietic stem cell transplantation compared with cyclosporine plus mycofenolate

Haematologica

Volumn 98, Issue 4, 2013, Pages 526-532

  Perez Simón, Jose Antonio ^a,b   Martino, Rodrigo ^c   Parody, Rocío ^a   Cabrero, Mónica ^b   Lopez Corral, Lucía ^b   Valcarcel, David ^c   Martinez, Carmen ^d   Solano, Carlos ^e   Vazquez, Lourdes ^b   Márquez Malaver, Francisco J ^a   Sierra, Jordi ^c   Caballero, Dolores ^b  

^a CSIC   (Spain)

^b HOSPITAL UNIVERSITARIO DE SALAMANCA   (Spain)

^c HOSPITAL DE LA SANTA CREU I SANT PAU   (Spain)

^d HOSPITAL CLÍNIC   (Spain)

^e HOSPITAL CLÍNICO UNIVERSITARIO   (Spain)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIVIRUS AGENT; BUSULFAN; CYCLOSPORIN; FLUCONAZOLE; FLUDARABINE; GRANULOCYTE COLONY STIMULATING FACTOR; HEPARIN; MYCOPHENOLIC ACID 2 MORPHOLINOETHYL ESTER; PHENYTOIN; RAPAMYCIN; TACROLIMUS;

ADULT; ARTICLE; COMPARATIVE STUDY; CONTINUOUS INFUSION; DRUG BLOOD LEVEL; DRUG DOSE REDUCTION; DRUG WITHDRAWAL; EVENT FREE SURVIVAL; FEMALE; GASTROINTESTINAL TOXICITY; GRAFT VERSUS HOST REACTION; HEMATOPOIETIC STEM CELL TRANSPLANTATION; HUMAN; IMMUNOASSAY; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NEUROTOXICITY; OVERALL SURVIVAL; PROSPECTIVE STUDY; THROMBOTIC THROMBOCYTOPENIC PURPURA; VIRUS REACTIVATION;

ADULT; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; COMBINED MODALITY THERAPY; CYCLOSPORINE; DISEASE-FREE SURVIVAL; FEMALE; GASTROINTESTINAL DISEASES; GRAFT VS HOST DISEASE; HEMATOLOGIC NEOPLASMS; HEMATOPOIETIC STEM CELL TRANSPLANTATION; HUMANS; INFECTION; MALE; MIDDLE AGED; MYCOPHENOLIC ACID; PROSPECTIVE STUDIES; SIROLIMUS; SURVIVAL RATE; TACROLIMUS; TIME FACTORS; TRANSPLANTATION CONDITIONING; TRANSPLANTATION, HOMOLOGOUS; TREATMENT OUTCOME; UNRELATED DONORS; YOUNG ADULT;

EID: 84875680385     PISSN: 03906078     EISSN: 15928721     Source Type: Journal    
DOI: 10.3324/haematol.2012.065599     Document Type: Article

References (38)

1. Storb R, Deeg HJ, Whitehead J, Appelbaum F, Beatty P, Bensinger W, et al. Methotrexate and cyclosporine compared with cyclo-sporine alone for prophylaxis of acute graft versus host disease after marrow transplantation for leukemia. N Engl J Med. 1986; 314(12):729-35.
2. Slavin S, Nagler A, Naparstek E, Kapelushnik Y, Aker M, Cividalli G, et al. Non-myeloablative stem cell transplantation and cell therapy as an alternative to conventional bone marrow transplantation with lethal cytoreduction for the treatment of malignant and nonmalignant hematologic diseases. Blood. 1998;91(3):756-63.
3. Perez-Simon JA, Martino R, Caballero D, Valcarcel D, Rebollo N, Caballero D, et al. Reduced-intensity conditioning allogeneic transplantation from unrelated donors: evaluation of mycofenolate mofetil plus cyclosporin A as graft-versus-host disease prophylaxis. Biol Blood Marrow Transplant. 2008;14(6):664-71.
4. Nash RA, Antin JH, Karanes C, Fay JW, Avalos BR, Yeager AM, 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(6):2062-8.
5. Deeg HJ, Flowers ME, Leisenring W, Appelbaum FR, Martin PJ, Storb RF. Cyclosporine (CSP) or CSP plus methylprednisolone for graft-versus-host disease prophylaxis in patients with high-risk lymphohemopoietic malignancies: long-term follow-up of a randomized trial. Blood. 2000;96(3):1194-5.
6. Cutler C, Kim HT, Hochberg E, Ho V, Alyea E, Lee SJ, et al. Sirolimus and tacrolimus without methotrexate as graft-versus-host disease prophylaxis after matched related donor peripheral blood stem cell transplantation. Biol Blood Marrow Transplant. 2004;10(5):328-36.
7. Ratanatharathorn V, Nash R. A, Przepiorka D, Devine SM, Klein JL, Weisdorf 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(7):2303-14.
8. Ho VT, Aldridge J, Kim HT, Cutler, C, Koreth, J, Armand, P, 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(7):844-50.
9. Rotta M, Storer BE, Sahebi F, Shizuru JA, Bruno B, Lange T, et al. Long-term outcome of patients with multiple myeloma after autologous hematopoietic cell transplantation and nonmyeloablative allografting. Blood. 2009;113(14):3383-91.
10. Rodriguez R, Parker P, Nademanee A, Smith D, O'Donnell M R, Stein A, et al. Cyclosporine and mycofenolate mofetil prophylaxis with fludarabine and melphalan conditioning for unrelated donor transplantation: a prospective study of 22 patients with hematologic malignancies. Bone Marrow Transplant. 2004;33(11):1123-9.
11. Nash RA, Johnston L, Parker P, McCune JS, Storer B, Slattery JT, et al. A phase I/II study of mycofenolate mofetil in combination with cyclosporine for prophylaxis of acute graft-versus-host disease after myeloablative conditioning and allogeneic hematopoietic cell transplantation. Biol Blood Marrow Transplant. 2005;11(7):495-505.
12. Gyurkocza B, Storb R, Storer BE, Chauncey TR, Lange T, Shizuru JA, et al. Non-myeloablative allogeneic hematopoietic cell transplantation in patients with acute myeloid leukemia. J Clin Oncol. 2010;28 (17):2859-67.
13. Giralt S. Update on non-myeloablative stem cell transplantation for hematologic malignancies. Int J Hematol. 2002;76(Suppl 1):368-75.
14. Rodriguez R, Nakamura R, Palmer JM, Parker P, Shayani S, Nademanee A, et al. A phase II pilot study of tacrolimus/sirolimus GVHD prophylaxis for sibling donor hematopoietic stem cell transplantation using 3 conditioning regimens. Blood. 2010;115(5):1098-105.
15. Cutler C, Antin JH. Sirolimus for GVHD prophylaxis in allogeneic stem cell transplantation. Bone Marrow Transplant. 2004;34(6):471-6.
16. Claxton DF, Ehmann C, Rybka W. Control of advanced and refractory acute myelogenous leukaemia with sirolimus-based nonmyeloablative allogeneic stem cell transplantation. Br J Haematol. 2005;130(2):256-64.
17. Antin JH, Kim HT, Cutler C, Ho VT, Lee SJ, Miklos DB, et al. Sirolimus, tacrolimus, and low-dose methotrexate for graft-versus-host disease prophylaxis in mismatched related donor or unrelated donor transplantation. Blood. 2003;102(5):1601-5.
18. Alyea EP, Li S, Kim HT, Cutler C, Ho V, Soiffer RJ, et al. Sirolimus, tacrolimus, and low-dose methotrexate as graft-versus-host disease prophylaxis in related and unrelated donor reduced-intensity conditioning allogeneic peripheral blood stem cell transplantation. Biol Blood Marrow Transplant. 2008;14(8):920-6.
19. Furlong T, Kiem HP, Appelbaum FR, Carpenter PA, Deeg HJ, Doney K, et al. Sirolimus in combination with cyclosporine or tacrolimus plus methotrexate for prevention of graft-versus-host disease following hematopoietic cell transplantation from unrelated donors. Biol Blood Marrow Transplant. 2008;14(5):531-7.
20. Martino R, Caballero MD, Canals C, Simon JA, Solano C, Urbano-Ispizua A, et al. Allogeneic peripheral blood stem cell transplantation with reduced-intensity conditioning: results of a prospective multicentre study. Br J Haematol. 2001;115(3):653-9.
21. Perez-Simon JA, Diez-Campelo M, Martino R, Sureda A, Caballero D, Cañizo C, et al. Impact of CD34+ cell dose on the outcome of patients undergoing reduced-intensityconditioning allogeneic peripheral blood stem cell transplantation. Blood. 2003;102 (3):1108-13.
22. Valcarcel D, Martino R, Caballero D, Martin J, Ferra C, Nieto JB, et al. Sustained remissions of high-risk acute myeloid leukemia and myelodysplastic syndrome after reduced-intensity conditioning allogeneic hematopoietic transplantation: chronic graft-versus-host disease is the strongest factor improving survival. J Clin Oncol. 2008; 26(4):577-84.
23. Przepiorka D, Weisdorf D, Martin P, Klingemann HG, Beatty P, Hows J, et al. 1994 Consensus Conference on Acute GVHD Grading. Bone Marrow Transplant. 1995;15(6):825-8.
24. Sullivan KM. Chronic graft-versus-host disease. Cancer Treat Res. 1990;50:79-98.
25. Batts ED, Lazarus HM. Diagnosis and treatment of transplantation-associated thrombotic microangiopathy: real progress or are we still waiting? Bone Marrow Transplant. 2007;40(8):709-19.
26. Wang R, Lagakos SW, Gray RJ. Testing and interval estimation for two-sample survival comparisons with small sample sizes and unequal censoring. Biostatistics. 2010;11(4): 676-92.
27. Sorror ML, Leisenring W, Deeg HJ, Martin PJ, Storb R. Twenty-year follow-up of a controlled trial comparing a combination of methotrexate plus cyclosporine with cyclosporine alone for prophylaxis of graftversus-host disease in patients administered HLA-identical marrow grafts for leukemia. Biol Blood Marrow Transplant. 2005;11 (10):814-25.
28. Storb R, Antin JH, Cutler C. Should methotrexate plus calcineurin inhibitors be considered standard of care for prophylaxis of acute graft-versus-host disease? Biol Blood Marrow Transplant. 2010;16(1 Suppl):S18-27.
29. Cutler C, Stevenson K, Kim HT, Richardson P, Ho VT, Linden E, et al. Sirolimus is associated with veno-occlusive disease of the liver after myeloablative allogeneic stem cell transplantation. Blood. 2008;112(12):4425-31.
30. Cutler C, Henry NL, Magee C, Li S, Kim HT, Alyea E, et al. Sirolimus and thrombotic microangiopathy after allogeneic hemato-poietic stem cell transplantation. Biol Blood Marrow Transplant. 2005;11(7):551-7.
31. Cutler C, Antin JH. Sirolimus immunosuppression for graft-versus-host disease prophylaxis and therapy: an update. Curr Opin Hematol. 2010;17(6):500-4.
32. Cutler C, Li S, Ho VT, Koreth J, Alyea E, Soiffer RJ, 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(7): 3108-14.
33. Rezvani AR, Norasetthada L, Gooley T, Sorror M, Bouvier ME, Sahebi F, et al. Nonmyeloablative allogeneic haematopoietic cell transplantation for relapsed diffuse large B-cell lymphoma: a multicentre experience. Br J Haematol. 2008;143(3):395-403.
34. Rezvani AR, Storer B, Maris M, Sorror ML, Agura E, Maziarz RT, et al. Nonmy-eloablative allogeneic hematopoietic cell transplantation in relapsed, refractory, and transformed indolent non-Hodgkin's lymphoma. J Clin Oncol. 2008;26(2):211-7.
35. Flowers ME, Traina F, Storer B, Maris M, Bethge WA, Carpenter P, et al. Serious graftversus-host disease after hematopoietic cell transplantation following nonmyeloablative conditioning. Bone Marrow Transplant. 2005;35(3):277-82.
36. Sorror M, Storer B, Sandmaier B, Maris M, Shizuru J, Maziarz R, et al. Five-year followup of patients with advanced chronic lymphocytic leukemia treated with allogeneic hematopoietic cell transplantation after nonmyeloablative conditioning. Clin Oncol. 2012;26(30):4912-20.
37. Marty FM, Bryar J, Browne SK, Schwarzberg T, Ho VT, Bassett IV, et al. Sirolimus-based graft-versus-host disease prophylaxis protects against cytomegalovirus reactivation after allogeneic hematopoietic stem cell transplantation: a cohort analysis. Blood. 2007;110(2):490-500.
38. Armand P, Gannamaneni S, Kim HT, Cutler CS, Ho VT, Koreth J, et al. Improved survival in lymphoma patients receiving sirolimus for graft-versus-host disease prophylaxis after allogeneic hematopoietic stem-cell transplantation with reduced-intensity conditioning. J Clin Oncol. 2008;26(35):5767-74.