Impact of Postgrafting Immunosuppressive Regimens on Nonrelapse Mortality and Survival after Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplant Using the Fludarabine and Low-Dose Total-Body Irradiation 200-cGy

Biology of Blood and Marrow Transplantation

Volumn 13, Issue 7, 2007, Pages 790-805

  Koh, Liang Piu ^a,b   Chen, Chien Shing ^b,e   Tai, Bee Choo ^c   Hwang, William Y K ^a   Tan, Lip Kun ^b   Ng, Hong Yen ^a   Linn, Yeh Ching ^a   Koh, Mickey B C ^a   Goh, Yeow Tee ^a   Tan, Belinda ^b   Lim, Shan ^b   Lee, Yee Mei ^b   Tan, Kar Wai ^a   Liu, Te Chih ^b   Ng, Heng Joo ^a   Loh, Yvonne S M ^a   Mow, Benjamin M F ^b   Tan, Daryl C L ^a   Tan, Patrick H C ^d  

^a SINGAPORE GENERAL HOSPITAL   (Singapore)

^b NATIONAL UNIVERSITY HOSPITAL   (Singapore)

^c NATIONAL UNIVERSITY OF SINGAPORE   (Singapore)

^d MOUNT ELIZABETH MEDICAL CENTRE   (Singapore)

^e Dept Medicine Endocrinol Diabet   (Singapore)

Author keywords

Allogeneic transplant; Fludarabine; GVHD prophylaxis; Low dose TBI; Methotrexate; Nonmyleloablative

Indexed keywords

ACICLOVIR; CORTICOSTEROID; COTRIMOXAZOLE; CYCLOSPORIN; DACLIZUMAB; DASATINIB; FLUCONAZOLE; FLUDARABINE; FOSCARNET; GANCICLOVIR; IMATINIB; IMMUNOGLOBULIN; ITRACONAZOLE; METHOTREXATE; MYCOPHENOLIC ACID 2 MORPHOLINOETHYL ESTER; OKT 3; PREDNISOLONE; RAPAMYCIN; RECOMBINANT GRANULOCYTE COLONY STIMULATING FACTOR;

ACUTE GRAFT VERSUS HOST DISEASE; ADOLESCENT; ADULT; ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION; ALOPECIA; ARTICLE; BILIRUBIN BLOOD LEVEL; BLOOD TRANSFUSION; BONE MARROW SUPPRESSION; CHRONIC GRAFT VERSUS HOST DISEASE; CHRONIC MYELOID LEUKEMIA; CONTROLLED STUDY; CREATININE BLOOD LEVEL; CYTOMEGALOVIRUS INFECTION; DISEASE FREE SURVIVAL; DRUG EFFICACY; FEMALE; GRAFT FAILURE; GRAFT VERSUS HOST REACTION; HEMATOLOGIC DISEASE; HERPES SIMPLEX; HLA MATCHING; HUMAN; IMMUNOSUPPRESSIVE TREATMENT; INCIDENCE; MAJOR CLINICAL STUDY; MALE; MUCOSA INFLAMMATION; MYCOSIS; NAUSEA; NEUTROPENIA; NEUTROPHIL COUNT; NONMYELOABLATIVE STEM CELL TRANSPLANTATION; OVERALL SURVIVAL; PERIPHERAL BLOOD STEM CELL TRANSPLANTATION; PNEUMOCYSTOSIS; PROBABILITY; RADIATION DOSE; RECURRENCE RISK; SIDE EFFECT; THROMBOCYTE TRANSFUSION; THROMBOCYTOPENIA; VEIN OCCLUSION; WHOLE BODY RADIATION;

ADOLESCENT; ADULT; ANTINEOPLASTIC AGENTS; DISEASE-FREE SURVIVAL; FEMALE; HEMATOLOGIC NEOPLASMS; HEMATOPOIETIC STEM CELL TRANSPLANTATION; HUMANS; IMMUNOSUPPRESSION; IMMUNOSUPPRESSIVE AGENTS; MALE; MIDDLE AGED; PERIPHERAL BLOOD STEM CELL TRANSPLANTATION; RETROSPECTIVE STUDIES; SURVIVAL RATE; TRANSPLANTATION CONDITIONING; TRANSPLANTATION, HOMOLOGOUS; VIDARABINE; WHOLE-BODY IRRADIATION;

EID: 34250191090     PISSN: 10838791     EISSN: 15236536     Source Type: Journal    
DOI: 10.1016/j.bbmt.2007.03.002     Document Type: Article

References (72)

1. Giralt S., Thall P.F., Khouri I., et al. Melphalan and purine analog-containing preparative regimens: reduced-intensity conditioning for patients with hematologic malignancies undergoing allogeneic progenitor cell transplantation. Blood 97 (2001) 631-637
2. Slavin S., Nagler A., Naparstek E., et al. Nonmyeloablative 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 91 (1998) 756-763
3. McSweeney P.A., Niederwieser D., Shizuru J.A., et al. Hematopoietic cell transplantation in older patients with hematologic malignancies: replacing high-dose cytotoxic therapy with graft-versus-tumor effects. Blood 97 (2001) 3390-3400
4. Niederwieser D., Maris M., Shizuru J.A., et al. Low-dose total body irradiation (TBI) and fludarabine followed by hematopoietic cell transplantation (HCT) from HLA-matched or mismatched unrelated donors and postgrafting immunosuppression with cyclosporine and mycophenolate mofetil (MMF) can induce durable complete chimerism and sustained remissions in patients with hematological diseases. Blood 101 (2003) 1620-1629
5. Maris M.B., Sandmaier B.M., Storer B.E., et al. Allogeneic hematopoietic cell transplantation after fludarabine and 2 Gy total body irradiation for relapsed and refractory mantle cell lymphoma. Blood 104 (2004) 3535-3542
6. Mielcarek M., Martin P.J., Leisenring W., et al. Graft-versus-host disease after nonmyeloablative versus conventional hematopoietic stem cell transplantation. Blood 102 (2003) 756-762
7. Mielcarek M., Burroughs L., Leisenring W., et al. Prognostic relevance of "early-onset" graft-versus-host disease following non-myeloablative haematopoietic cell transplantation. Br J Haematol 129 (2005) 381-391
8. Baron F., Maris M.B., Sandmaier B.M., et al. Graft-versus-tumor effects after allogeneic hematopoietic cell transplantation with nonmyeloablative conditioning. J Clin Oncol 23 (2005) 1993-2003
9. Kottaridis P.D., Milligan D., Chopra R., et al. In vivo CAMPATH-IH prevents graft-versus-host disease following nonmyeloablative stem cell transplantation. Blood 96 (2000) 2419-2425
10. Morris E., Thomson K., Craddock C., et al. Outcomes after alemtuzumab-containing reduced-intensity allogeneic transplantation regimen for relapsed and refractory non-Hodgkin lymphoma. Blood 104 (2004) 3865-3871
11. Ho A.Y., Pagliuca A., Kenyon M., et al. Reduced intensity allogeneic hematopoietic stem cell transplantation for myelodysplastic syndrome and acute myeloid leukemia with multilineage dysplasia using fludarabine, busulphan, and alemtuzumab (FBC) conditioning. Blood 104 (2004) 1616-1623
12. Peggs K.S., Hunter A., Chopra R., et al. Clinical evidence of a graft versus Hodgkin's lymphoma effect after reduced intensity allogeneic transplantation. Lancet 365 (2005) 1934-1941
13. Faulkner R., Craddock C., Byrne J., et al. BEAM-alemtuzumab reduced intensity allogeneic stem cell transplantation for lymphoproliferative diseases: GVHD, toxicity, and survival in 65 patients. Blood 103 (2004) 428-434
14. Weiden P.L., Flournoy N., Thomas E.D., et al. Antileukemic effect of graft-versus-host disease in human recipients of allogeneic-marrow grafts. N Engl J Med 300 (1979) 1068-1073
15. Horowitz M.M., Gale R.P., Sondel P.M., et al. Graft-versus-leukemia reactions after bone marrow transplantation. Blood 75 (1990) 555-562
16. Weiden P.L., Sullivan K.M., Flournoy N., Storb R., and Thomas E.D. Antileukemic effect of chronic graft-versus-host disease: contribution to improved survival after allogeneic marrow transplantation. N Engl J Med 304 (1981) 1529-1533
17. Slavin S., Weiss L., Morecki S., and Weigensberg M. Eradication of murine leukemia with histoincompatible marrow grafts in mice conditioned with total lymphoid irradiation. Cancer Immunother 11 (1981) 155-158
18. Storb R., Yu C., Wagner J.L., et al. Stable mixed hematopoietic chimerism in DLA-identical littermate dogs given sublethal total body irradiation before and pharmacological immunosuppression after marrow transplantation. Blood 89 (1997) 3048-3054
19. Giralt S., Estey E., Albitar M., et al. Engraftment of allogeneic hematopoietic progenitor cells with purine analog-containing chemotherapy: harnessing graft versus leukemia without myeloablative therapy. Blood 89 (1997) 4531-4536
20. Kroger N., Shaw B., Iacobelli S., et al. Comparison between antithymocyte globulin and alemtuzumab and the possible impact of KIR-ligand mismatch after dose reduced conditioning and unrelated stem cell transplantation in patients with multiple myeloma. Br J Haematol 129 (2005) 631-643
21. Crawley C., Lalancette M., Szydlo R., et al. Outcomes for reduced intensity allogeneic transplantation for multiple myeloma; an analysis of prognostic factors from the Chronic Leukemia Working Party of the EBMT. Blood 105 (2005) 4532-4539
22. Perez-Simon J.A., Kottaridis P.D., Martino R., et al. Nonmyeloablative transplantation with or without alemtuzumab: comparison between 2 prospective studies in patients with lymphoproliferative disorders. Blood 100 (2002) 3121-3127
23. Crawley C., Szydlo R., Lalancette M., et al. Outcomes of reduced-intensity transplantation for chronic myeloid leukemia: an analysis of prognostic factors from the Chronic Leukemia Working Party of the EBMT. Blood 106 (2005) 2969-2976
24. Ramsay N.K.C., Kersey J.H., Robison L.L., et al. A randomized study of the prevention of acute graft-versus-host disease. N Engl J Med 306 (1982) 392-397
25. 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 73 (1989) 1729-1734
26. Storb R., Deeg H.J., Pepe M., et al. Graft-versus-host disease prevention by methotrexate combined with cyclosporin compared to methotrexate alone in patients given marrow grafts for severe aplastic anaemia: long-term follow-up of a controlled trial. Br J Haematol 72 (1989) 567-572
27. Storb R., Deeg H.J., 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 20 314 (1986) 729-735
28. Chao N.J., Schmidt G.M., Niland J.C., et al. Cyclosporine, methotrexate, and prednisone compared with cyclosporine and prednisone for prophylaxis of acute graft-versus-host disease. N Engl J Med 329 (1993) 1225-1230
29. Deeg H.J., Lin D., Leisenring W., et al. Cyclosporine or cyclosporine plus methylprednisolone for prophylaxis of graft-versus-host disease: a prospective, randomized trial. Blood 89 (1997) 3880-3887
30. 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 92 (1998) 2303-2314
31. Ruutu T., Volin L., Parkkali T., et al. Cyclosporine, methotrexate, and methylprednisolone compared with cyclosporine and methotrexate for the prevention of graft-versus-host disease in bone marrow transplantation from HLA-identical sibling donor: a prospective randomized study. Blood 96 (2000) 2391-2398
32. Locatelli F., Bruno B., Zecca M., et al. Cyclosporin A and short-term methotrexate versus cyclosporin A as graft versus host disease prophylaxis in patients with severe aplastic anemia given allogeneic bone marrow transplantation from an HLA-identical sibling: results of a GITMO/EBMT randomized trial. Blood 96 (2000) 1690-1697
33. 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 96 (2000) 2062-2068
34. Srinivasan R., Geller N., Chakrabarti S., et al. Evaluation of three different cyclosporine-based graft versus host disease (GVHD) prophylaxis regimens following nonmyeloablative hematopoietic stem cell transplantation (NST) [abstract 1236]. Blood 104 Supp 1 (2004) 349a
35. Chao N.J., Snyder D.S., 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 6 (2000) 254-261
36. Sandmaier B.M., Maris M., Maloney D.G., et al. Low-dose total body irradiation (TBI)conditioning for hematopoietic cell transplantation (HCT) from HLA-matched related (MRD) and unrelated (URD) donors for patients with hematologic malignancies: a 5 year experience [abstract 264]. Blood 102 Suppl 1 (2003) 78a-79a
37. Ugozzoli L., Yam P., Petz L.D., et al. Amplification by the polymerase chain reaction of hypervariable regions of the human genome for evaluation of chimerism after bone marrow transplantation. Blood 77 (1991) 1607-1615
38. Przepiorka D., Weisdorf D., Martin P., et al. Consensus conference on acute GVHD grading. Bone Marrow Transplant 15 (1995) 825-828
39. Sullivan K.M., Agura E., Anasetti C., et al. Chronic graft-versus-host disease and other late complications of bone marrow transplantation. Semin Hematol 28 (1991) 250-259
40. Common terminology criteria for adverse events. Available at: http://ctep.cancer.gov/reporting/ctc.html.
41. Klein J.P., Rizzo J.D., Zhang M.J., and Keiding N. Statistical methods for the analysis and presentation of the results of bone marrow transplants. Part I: unadjusted analysis. Bone Marrow Transplant 28 (2001) 909-915
42. Klein J.P., Rizzo J.D., Zhang M.J., and Keiding N. Statistical methods for the analysis and presentation of the results of bone marrow transplants. Part 2: Regression modeling. Bone Marrow Transplant 28 (2001) 1001-1011
43. Tai B.C., Machin D., White I., Gebski V., and European Osteosarcoma Intergroup. Competing risks analysis of patients with osteosarcoma: a comparison of four different approaches. Stat Med 20 (2001) 661-684
44. Craddock C., Szydlo R.M., Klein J.P., et al. Estimating leukemia-free survival after allografting for chronic myeloid leukemia: a new method that takes into account patients who relapse and are restored to complete remission. Blood 96 (2000) 86-90
45. Kaplan E.L., and Meier P. Nonparametric estimation from incomplete observations. J Am Stat Assoc 53 (1958) 457-481
46. Mantel N. Evaluation of survival data and two new rank order statistics arising in its consideration. Cancer Chemother Rep 50 (1966) 163-170
47. Junghanss C., Boeckh M., Carter R.A., et al. Incidence and outcome of cytomegalovirus infections following nonmyeloablative compared with myeloablative allogeneic stem cell transplantation, a matched control study. Blood 99 (2002) 1978-1985
48. Nash R.A., Pepe M.S., Storb R., et al. Acute graft-versus-host disease: analysis of risk factors after allogeneic marrow transplantation and prophylaxis with cyclosporine and methotrexate. Blood 80 (1992) 1838-1845
49. Storb R., Prentice R.L., Buckner C.D., et al. Graft-versus-host disease and survival in patients with aplastic anemia treated by marrow grafts from HLA-identical siblings. Beneficial effect of a protective environment. N Engl J Med 308 (1983) 302-307
50. Oh H., Loberiza Jr. F.R., Zhang M.J., et al. Comparison of graft-versus-host-disease and survival after HLA-identical sibling bone marrow transplantation in ethnic populations. Blood 105 (2005) 1408-1416
51. Lin M.T., Storer B., Martin P.J., et al. Relation of an interleukin-10 promoter polymorphism to graft-versus-host disease and survival after hematopoietic-cell transplantation. N Engl J Med 349 (2003) 2201-2210
52. de Lima M., Anagnostopoulos A., Munsell M., et al. Nonablative versus reduced-intensity conditioning regimens in the treatment of acute myeloid leukemia and high-risk myelodysplastic syndrome: dose is relevant for long-term disease control after allogeneic hematopoietic stem cell transplantation. Blood 104 (2004) 865-872
53. Hegenbart U., Niederwieser D., Sandmaier B.M., et al. Treatment for acute myelogenous leukemia by low-dose, total-body, irradiation-based conditioning and hematopoietic cell transplantation from related and unrelated donors. J Clin Oncol 24 (2006) 444-453
54. Bethge W.A., Storer B.E., Maris M.B., et al. Relapse or progression after hematopoietic cell transplantation using nonmyeloablative conditioning: effect of interventions on outcome. Exp Hematol 31 (2003) 974-980
55. van Besien K., Artz A., Smith S., et al. Fludarabine, melphalan, and alemtuzumab conditioning in adults with standard-risk advanced acute myeloid leukemia and myelodysplastic syndrome. J Clin Oncol 23 (2005) 5728-5738
56. Alyea E.P., Kim H.T., Ho V., et al. Comparative outcome of nonmyeloablative and myeloablative allogeneic hematopoietic cell transplantation for patients older than 50 years of age. Blood 105 (2005) 1810-1814
57. Maris M.B., Niederwieser D., Sandmaier B.M., et al. HLA-matched unrelated donor hematopoietic cell transplantation after nonmyeloablative conditioning for patients with hematologic malignancies. Blood 102 (2003) 2021-2030
58. Sloand E., Childs R.W., Solomon S., et al. The graft-versus-leukemia effect of nonmyeloablative stem cell allografts may not be sufficient to cure chronic myelogenous leukemia. Bone Marrow Transplant 32 (2003) 897-901
59. Michallet M., Bilger K., Garban F., et al. Allogeneic hematopoietic stem-cell transplantation after nonmyeloablative preparative regimens: impact of pretransplantation and posttransplantation factors on outcome. J Clin Oncol 19 (2001) 3340-3349
60. Robinson S.P., Goldstone A.H., Mackinnon S., et al. Chemoresistant or aggressive lymphoma predicts for a poor outcome following reduced-intensity allogeneic progenitor cell transplantation: an analysis from the Lymphoma Working Party of the European Group for Blood and Bone Marrow Transplantation. Blood 100 (2002) 4310-4316
61. Koh L.P., Koh M.B., Ng H.Y., et al. Allogeneic hematopoietic stem cell transplantation for patients with severe aplastic anemia following nonmyeloablative conditioning using 200-cGy total body irradiation and fludarabine. Biol Blood Marrow Transplant 12 (2006) 887-890
62. Ferrara J.L., and Reddy P. Pathophysiology of graft-versus-host disease. Semin Hematol 43 (2006) 3-10
63. Hill G.R., and Ferrara J.L. The primacy of the gastrointestinal tract as a target organ of acute graft-versus-host disease: rationale for the use of cytokine shields in allogeneic bone marrow transplantation. Blood 95 (2000) 2754-2759
64. Ho V.T., Weller E., Lee S.J., Alyea E.P., Antin J.H., and Soiffer R.J. Prognostic factors for early severe pulmonary complications after hematopoietic stem cell transplantation. Biol Blood Marrow Transplant 7 (2001) 223-229
65. Cutler C., Kim H.T., 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 10 (2004) 328-336
66. Bolwell B., Sobecks R., Pohlman B., et al. A prospective randomized trial comparing cyclosporine and short course methotrexate with cyclosporine and mycophenolate mofetil for GVHD prophylaxis in myeloablative allogeneic bone marrow transplantation. Bone Marrow Transplant 34 (2004) 621-625
67. Copelan E.A., Penza S.L., Theil K.S., et al. The influence of early transplantation, age, GVHD prevention regimen, and other factors on outcome of allogeneic transplantation for CML following BuCy. Bone Marrow Transplant 26 (2000) 1037-1043
68. Kumar S., Chen M.G., Gastineau D.A., et al. Prophylaxis of graft-versus-host disease with cyclosporine-prednisone is associated with increased risk of chronic graft-versus-host disease. Bone Marrow Transplant 27 (2001) 1133-1140
69. Ross M., Schmidt G.M., Niland J.C., et al. Cyclosporine, methotrexate, and prednisone compared with cyclosporine and prednisone for prevention of acute graft-vs-host disease: effect on chronic graft-vs.-host disease and long-term survival. Biol Blood Marrow Transplant 5 (1999) 285-291
70. 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 23 (2005) 5074-5087
71. Burroughs L., Mielcarek M., Leisenring W., et al. Extending postgrafting cyclosporine decreases the risk of severe graft-versus-host disease after nonmyeloablative hematopoietic cell transplantation. Transplantation 81 (2006) 818-825
72. Nieto Y., Patton N., Hawkins T., et al. Tacrolimus and mycophenolate mofetil after nonmyeloablative matched-sibling donor allogeneic stem-cell transplantations conditioned with fludarabine and low-dose total body irradiation. Biol Blood Marrow Transplant 12 (2006) 217-225