Tacrolimus/sirolimus vs tacrolimus/methotrexate as GVHD prophylaxis after matched, related donor allogeneic HCT

Blood

Volumn 124, Issue 8, 2014, Pages 1372-1377

  Cutler, Corey ^a   Logan, Brent ^b   Nakamura, Ryotaro ^c   Johnston, Laura ^d   Choi, Sung ^e   Porter, David ^f   Hogan, William J ^g   Pasquini, Marcelo ^b   MacMillan, Margaret L ^h   Hsu, Jack W ⁱ   Waller, Edmund K ^j   Grupp, Stephan ^k   McCarthy, Philip ^l   Wu, Juan ^m   Hu, Zhen Huan ^b   Carter, Shelly L ^m   Horowitz, Mary M ^b   Antin, Joseph H ^a  

^a HARVARD MEDICAL SCHOOL   (United States)

^b MEDICAL COLLEGE OF WISCONSIN   (United States)

^c CITY OF HOPE NATIONAL MEDICAL CENTER   (United States)

^d STANFORD UNIVERSITY   (United States)

^e UNIVERSITY OF MICHIGAN   (United States)

^f UNIVERSITY OF PENNSYLVANIA   (United States)

^g MAYO CLINIC   (United States)

^h UNIVERSITY OF MINNESOTA MEDICAL SCHOOL   (United States)

ⁱ UNIVERSITY OF FLORIDA   (United States)

^j EMORY UNIVERSITY   (United States)

^k CHILDREN S HOSPITAL OF PHILADELPHIA   (United States)

^l ROSWELL PARK CANCER INSTITUTE   (United States)

^m EMMES CORPORATION   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ALANINE AMINOTRANSFERASE; ASPARTATE AMINOTRANSFERASE; BILIRUBIN GLUCURONIDE; CHOLESTEROL; CREATININE; HEMOGLOBIN; METHOTREXATE; RAPAMYCIN; TACROLIMUS; TRIACYLGLYCEROL;

ADULT; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; BILIRUBIN BLOOD LEVEL; CHOLESTEROL BLOOD LEVEL; CREATININE BLOOD LEVEL; CREATININE CLEARANCE; CYTOMEGALOVIRUS INFECTION; DISEASE FREE SURVIVAL; ENDOTHELIUM INJURY; FEMALE; GRAFT VERSUS HOST REACTION; HUMAN; MAJOR CLINICAL STUDY; MALE; MORTALITY; MUCOSA INFLAMMATION; MULTICENTER STUDY; NEUTROPHIL; OPEN STUDY; OROPHARYNGEAL MUCOSITIS; OVERALL SURVIVAL; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RECURRENCE FREE SURVIVAL; SURVIVAL RATE; SURVIVAL TIME; SYNDROME; THROMBOCYTE; THROMBOTIC THROMBOCYTOPENIC PURPURA; TRIACYLGLYCEROL BLOOD LEVEL;

ADOLESCENT; ADULT; ALLOGRAFTS; DISEASE-FREE SURVIVAL; FEMALE; FOLLOW-UP STUDIES; GRAFT VS HOST DISEASE; HEMATOPOIETIC STEM CELL TRANSPLANTATION; HUMANS; IMMUNOSUPPRESSIVE AGENTS; MALE; METHOTREXATE; MIDDLE AGED; SIROLIMUS; STOMATITIS; SURVIVAL RATE; TACROLIMUS; TIME FACTORS;

EID: 84907357105     PISSN: 00064971     EISSN: 15280020     Source Type: Journal    
DOI: 10.1182/blood-2014-04-567164     Document Type: Article

References (34)

1. Gooley TA, Chien JW, Pergam SA, et al. Reduced mortality after allogeneic hematopoietic-cell transplantation. N Engl J Med. 2010;363(22):2091-2101.
2. Saber W, Cutler CS, Nakamura R, et al. Impact of donor source on hematopoietic cell transplantation outcomes for patients with myelodysplastic syndromes (MDS). Blood. 2013;122(11):1974-1982.
3. Saber W, Opie S, Rizzo JD, Zhang MJ, Horowitz MM, Schriber J. Outcomes after matched unrelated donor versus identical sibling hematopoietic cell transplantation in adults with acute myelogenous leukemia. Blood. 2012;119(17):3908-3916.
4. Storb R, Deeg HJ, Farewell V, et al. Marrow transplantation for severe aplastic anemia: methotrexate alone compared with a combination of methotrexate and cyclosporine for prevention of acute graft-versus-host disease. Blood. 1986;68(1):119-125. (Pubitemid 16041720)
5. Storb R, Deeg HJ, Whitehead J, et al. Methotrexate and cyclosporine compared with cyclosporine alone for prophylaxis of acute graft versus host disease after marrow transplantation for leukemia. N Engl J Med. 1986;314(12):729-735. (Pubitemid 16124386)
6. Perkins J, Field T, Kim J, et al. A randomized phase II trial comparing tacrolimus and mycophenolate mofetil to tacrolimus and methotrexate for acute graft-versus-host disease prophylaxis. Biol Blood Marrow Transplant. 2010;16(7):937-947.
7. Antin JH, Weisdorf D, Neuberg D, et al. Interleukin-1 blockade does not prevent acute graft-versus-host disease: results of a randomized, double-blind, placebo-controlled trial of interleukin-1 receptor antagonist in allogeneic bone marrow transplantation. Blood. 2002;100(10):3479-3482.
8. Chao NJ, Snyder DS, Jain M, et al. Equivalence of 2 effective graft-versus-host disease prophylaxis regimens: results of a prospective double-blind randomized trial. Biol Blood Marrow Transplant. 2000;6(3):254-261.
9. Cutler C, Antin JH. Sirolimus for GVHD prophylaxis in allogeneic stem cell transplantation. Bone Marrow Transplant. 2004;34(6):471-476. (Pubitemid 39264035)
10. Cutler C, Kim HT, Hochberg E, 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):328-336. (Pubitemid 38519571)
11. Cutler C, Li S, Ho VT, 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):3108-3114. (Pubitemid 46482114)
12. Rodriguez R, Nakamura R, Palmer JM, 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):1098-1105.
13. Pidala J, Kim J, Jim H, et al. A randomized phase II study to evaluate tacrolimus in combination with sirolimus or methotrexate after allogeneic hematopoietic cell transplantation. Haematologica. 2012;97(12):1882-1889.
14. Cutler C, Henry NL, Magee C, et al. Sirolimus and thrombotic microangiopathy after allogeneic hematopoietic stem cell transplantation. Biol Blood Marrow Transplant. 2005;11(7):551-557. (Pubitemid 40862452)
15. Cutler C, Stevenson K, Kim HT, et al. Sirolimus is associated with veno-occlusive disease of the liver after myeloablative allogeneic stem cell transplantation. Blood. 2008;112(12):4425-4431.
16. Shayani S, Palmer J, Stiller T, et al. Thrombotic microangiopathy associated with sirolimus level after allogeneic hematopoietic cell transplantation with tacrolimus/sirolimus-based graft-versus-host disease prophylaxis. Biol Blood Marrow Transplant. 2013;19(2):298-304.
17. Alyea EP, Li S, Kim HT, 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):920-926. (Pubitemid 351985030)
18. Nakamura R, Palmer JM, O'Donnell MR, et al. Reduced intensity allogeneic hematopoietic stem cell transplantation for MDS using tacrolimus/sirolimus-based GVHD prophylaxis. Leuk Res. 2012;36(9):1152-1156.
19. Cutler C, Stevenson K, Kim HT, et al. Double umbilical cord blood transplantation with reduced intensity conditioning and sirolimus-based GVHD prophylaxis. Bone Marrow Transplant. 2011;46(5):659-667.
20. Cutler C, Li S, Kim HT, et al. Mucositis after allogeneic hematopoietic stem cell transplantation: a cohort study of methotrexate- and non-methotrexate-containing graft-versus-host disease prophylaxis regimens. Biol Blood Marrow Transplant. 2005;11(5):383-388. (Pubitemid 40542931)
21. Ho VT, Weller E, Lee SJ, Alyea EP, Antin JH, Soiffer RJ. Prognostic factors for early severe pulmonary complications after hematopoietic stem cell transplantation. Biol Blood Marrow Transplant. 2001;7(4):223-229. (Pubitemid 32433249)
22. Antin JH, Ferrara JL. Cytokine dysregulation and acute graft-versus-host disease. Blood. 1992;80(12):2964-2968. (Pubitemid 23004498)
23. Przepiorka D, Weisdorf D, Martin P, et al. 1994 Consensus Conference on acute GVHD grading. Bone Marrow Transplant. 1995;15(6):825-828.
24. Shulman HM, Sullivan KM, Weiden PL, et al. Chronic graft-versus-host syndrome in man. A long-term clinicopathologic study of 20 Seattle patients. Am J Med. 1980;69(2):204-217. (Pubitemid 10036817)
25. Sonis ST, Eilers JP, Epstein JB, et al; Mucositis Study Group. Validation of a new scoring system for the assessment of clinical trial research of oral mucositis induced by radiation or chemotherapy. Cancer. 1999;85(10):2103-2113. (Pubitemid 29215547)
26. Armand P, Kim H, Sainvil M-M, et al. The addition of sirolimus to the GVHD prophylaxis regimen in reduced intensity allogeneic stem cell transplantation for lymphoma: a multicenter randomized trial [abstract]. Blood (ASH Annual Meeting Abstracts). 2013;122(21). Abstract 704.
27. Pulsipher MA, Langholz B, Wall DA, et al. The addition of sirolimus to tacrolimus/methotrexate GVHD prophylaxis in children with ALL: a phase 3 Children's Oncology Group/Pediatric Blood and Marrow Transplant Consortium trial. Blood. 2014;123(13):2017-2025.
28. Stem Cell Trialists' Collaborative Group. Allogeneic peripheral blood stem-cell compared with bone marrow transplantation in the management of hematologic malignancies: an individual patient data meta-analysis of nine randomized trials. J Clin Oncol. 2005;23(22):5074-5087.
29. Bellm LA, Cunningham G, Durnell L, et al. Defining clinically meaningful outcomes in the evaluation of new treatments for oral mucositis: oral mucositis patient provider advisory board. Cancer Invest. 2002;20(5-6):793-800. (Pubitemid 37210053)
30. Cutler C, Li S, Kim HT, et al. Oral mucositis incidence and severity after methotrexate and non-methotrexate containing GVHD prophylaxis regimens [abstract]. Blood (ASH Annual Meeting Abstracts). 2004;104(11). Abstract 351. PMID: 15846292.
31. Przepiorka D, Ippoliti C, Khouri I, et al. Tacrolimus and minidose methotrexate for prevention of acute graft-versus-host disease after matched unrelated donor marrow transplantation. Blood. 1996;88(11):4383-4389. (Pubitemid 26399187)
32. Luznik L, Chen A, Kaup M, et al. Posttransplantation high-dose cyclophosphamide (Cy) is effective single agent GVHD prophylaxis that permits prompt immune reconstitution after myeloablative HLA matched related and unrelated bone marrow transplantation (BMT) [abstract]. Blood (ASH Annual Meeting Abstracts). 2006;108(11). Abstract 2891. PMID: 20124511.
33. Ram R, Yeshurun M, Vidal L, Shpilberg O, Gafter-Gvili A. Mycophenolate mofetil vs. methotrexate for the prevention of graft-versus-host-disease - systematic review and meta-analysis. Leuk Res. 2014;38(3):352-360.
34. Cutler C, Kim HT, Ayanian S, et al. Prediction of veno-occlusive disease using biomarkers of endothelial injury. Biol Blood Marrow Transplant. 2010;16(8):1180-1185.