Targeted i.v. BU and fludarabine (t-i.v. BU/Flu) provides effective control of AML in adults with reduced toxicity

Bone Marrow Transplantation

Volumn 46, Issue 5, 2011, Pages 641-649

  Pidala, J ^a,b   Kim, J ^a,b   Anasetti, C ^a,b   Kharfan Dabaja, M A ^a,b   Field, T ^a,b   Perkins, J ^a,b   Ayala, E ^a,b   Perez, L ^a,b   Fernandez, H ^a,b  

^a H LEE MOFFITT CANCER CENTER AND RESEARCH INSTITUTE   (United States)

^b UNIVERSITY OF SOUTH FLORIDA   (United States)

Author keywords

allogeneic hematopoietic cell transplantation; AML; conditioning regimen; fludarabine; targeted BU

Indexed keywords

BUSULFAN; FLUDARABINE; METHOTREXATE; MYCOPHENOLIC ACID 2 MORPHOLINOETHYL ESTER; RAPAMYCIN; TACROLIMUS;

ACUTE GRAFT VERSUS HOST DISEASE; ACUTE GRANULOCYTIC LEUKEMIA; ADULT; AGED; ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION; AREA UNDER THE CURVE; ARTICLE; CANCER SURVIVAL; CHRONIC GRAFT VERSUS HOST DISEASE; DRUG DOSE INCREASE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; ENGRAFTMENT; FOLLOW UP; HIGH RISK PATIENT; HUMAN; LEUKEMIA RELAPSE; LEUKEMIA REMISSION; LIVER VENOOCCLUSIVE DISEASE; MAJOR CLINICAL STUDY; OVERALL SURVIVAL; PNEUMONIA; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; SEIZURE; SIDE EFFECT; TREATMENT FAILURE;

ADULT; AGED; BUSULFAN; GRAFT VS HOST DISEASE; HEMATOPOIETIC STEM CELL TRANSPLANTATION; HUMANS; INJECTIONS, INTRAVENOUS; LEUKEMIA, MYELOID, ACUTE; MIDDLE AGED; MYELOABLATIVE AGONISTS; RECURRENCE; REMISSION INDUCTION; TREATMENT OUTCOME; VIDARABINE;

EID: 79955924246     PISSN: 02683369     EISSN: 14765365     Source Type: Journal    
DOI: 10.1038/bmt.2010.190     Document Type: Article

References (54)

1. Cornelissen JJ, van Putten WL, Verdonck LF, Theobald M, Jacky E, Daenen SM et al. Results of a HOVON/SAKK donor versus no-donor analysis of myeloablative HLA-identical sibling stem cell transplantation in first remission acute myeloid leukemia in young and middle-aged adults: benefits for whom? Blood 2007; 109: 3658-3666. (Pubitemid 46641712)
2. Koreth J, Schlenk R, Kopecky KJ, Honda S, Sierra J, Djulbegovic BJ et al. Allogeneic stem cell transplantation for acute myeloid leukemia in first complete remission: systematic review and meta-analysis of prospective clinical trials. JAMA 2009; 301: 2349-2361.
3. Ringden O, Horowitz MM, Gale RP, Biggs JC, Gajewski J, Rimm AA et al. Outcome after allogeneic bone marrow transplant for leukemia in older adults. JAMA 1993; 270: 57-60. (Pubitemid 23202651)
4. Appelbaum FR. What is the impact of hematopoietic cell transplantation (HCT) for older adults with acute myeloid leukemia (AML)? Best Pract Res Clin Haematol 2008; 21: 667-675.
5. Hegenbart U, Niederwieser D, Sandmaier BM, Maris MB, Shizuru JA, Greinix H 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 2006; 24: 444-453. (Pubitemid 46630463)
6. de Lima M, Anagnostopoulos A, Munsell M, Shahjahan M, Ueno N, Ippoliti C et al. Nonablative versus reducedintensity 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 2004; 104: 865-872. (Pubitemid 38970586)
7. Tauro S, Craddock C, Peggs K, Begum G, Mahendra P, Cook G et al. Allogeneic stem-cell transplantation using a reduced-intensity conditioning regimen has the capacity to produce durable remissions and long-term disease-free survival in patients with high-risk acute myeloid leukemia and myelodysplasia. J Clin Oncol 2005; 23: 9387-9393.
8. van Besien K, Artz A, Smith S, Cao D, Rich S, Godley L et al. Fludarabine, melphalan, and alemtuzumab conditioning in adults with standard-risk advanced acute myeloid leukemia and myelodysplastic syndrome. J Clin Oncol 2005; 23: 5728-5738.
9. Blaise DP, Michel Boiron J, Faucher C, Mohty M, Bay JO, Bardoux VJ et al. Reduced intensity conditioning prior to allogeneic stem cell transplantation for patients with acute myeloblastic leukemia as a first-line treatment. Cancer 2005; 104: 1931-1938. (Pubitemid 41513177)
10. Sayer HG, Kroger M, Beyer J, Kiehl M, Klein SA, Schaefer- Eckart K et al. Reduced intensity conditioning for allogeneic hematopoietic stem cell transplantation in patients with acute myeloid leukemia: disease status by marrow blasts is the strongest prognostic factor. Bone Marrow Transplant 2003; 31: 1089-1095. (Pubitemid 36857366)
11. Shimoni A, Hardan I, Shem-Tov N, Yeshurun M, Yerushalmi R, Avigdor A et al. Allogeneic hematopoietic stem-cell transplantation in AML and MDS using myeloablative versus reduced-intensity conditioning: the role of dose intensity. Leukemia 2006; 20: 322-328. (Pubitemid 43148672)
12. 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: 577-584. (Pubitemid 351264351)
13. de Lima M, Couriel D, Thall PF, Wang X, Madden T, Jones R et al. Once-daily intravenous busulfan and fludarabine: clinical and pharmacokinetic results of a myeloablative, reducedtoxicity conditioning regimen for allogeneic stem cell transplantation in AML and MDS. Blood 2004; 104: 857-864. (Pubitemid 38970585)
14. Bornhauser M, Storer B, Slattery JT, Appelbaum FR, Deeg HJ, Hansen J et al. Conditioning with fludarabine and targeted busulfan for transplantation of allogeneic hematopoietic stem cells. Blood 2003; 102: 820-826. (Pubitemid 36917770)
15. Schmid C, Schleuning M, Ledderose G, Tischer J, Kolb HJ. Sequential regimen of chemotherapy, reduced-intensity conditioning for allogeneic stem-cell transplantation, and prophylactic donor lymphocyte transfusion in high-risk acute myeloid leukemia and myelodysplastic syndrome. J Clin Oncol 2005; 23: 5675-5687.
16. Schmid C, Schleuning M, Hentrich M, Markl GE, Gerbitz A, Tischer J et al. High antileukemic efficacy of an intermediate intensity conditioning regimen for allogeneic stem cell transplantation in patients with high-risk acute myeloid leukemia in first complete remission. Bone Marrow Transplant 2008; 41: 721-727. (Pubitemid 351596039)
17. Schmid C, Schleuning M, Schwerdtfeger R, Hertenstein B, Mischak-Weissinger E, Bunjes D et al. Long-term survival in refractory acute myeloid leukemia after sequential treatment with chemotherapy and reduced-intensity conditioning for allogeneic stem cell transplantation. Blood 2006; 108: 1092-1099. (Pubitemid 44154650)
18. Aoudjhane M, Labopin M, Gorin NC, Shimoni A, Ruutu T, Kolb HJ et al. Comparative outcome of reduced intensity and myeloablative conditioning regimen in HLA identical sibling allogeneic haematopoietic stem cell transplantation for patients older than 50 years of age with acute myeloblastic leukaemia: a retrospective survey from the Acute Leukemia Working Party (ALWP) of the European group for Blood and Marrow Transplantation (EBMT). Leukemia 2005; 19: 2304-2312. (Pubitemid 41748028)
19. Alyea EP, Kim HT, Ho V, Cutler C, Gribben J, DeAngelo DJ et al. Comparative outcome of nonmyeloablative and myeloablative allogeneic hematopoietic cell transplantation for patients older than 50 years of age. Blood 2005; 105: 1810-1814. (Pubitemid 40223707)
20. Feinstein LC, Sandmaier BM, Hegenbart U, McSweeney PA, Maloney DG, Gooley TA et al. Non-myeloablative allografting from human leucocyte antigen-identical sibling donors for treatment of acute myeloid leukaemia in first complete remission. Br J Haematol 2003; 120: 281-288. (Pubitemid 36194179)
21. Hassan M, Ljungman P, Bolme P, Ringden O, Syruckova Z, Bekassy A et al. Busulfan bioavailability. Blood 1994; 84: 2144-2150. (Pubitemid 24296370)
22. Ciurea SO, Andersson BS. Busulfan in hematopoietic stem cell transplantation. Biol Blood Marrow Transplant 2009; 15: 523-536.
23. Dix SP, Wingard JR, Mullins RE, Jerkunica I, Davidson TG, Gilmore CE et al. Association of busulfan area under the curve with veno-occlusive disease following BMT. Bone Marrow Transplant 1996; 17: 225-230. (Pubitemid 26057312)
24. Geddes M, Kangarloo SB, Naveed F, Quinlan D, Chaudhry MA, Stewart D et al. High busulfan exposure is associated with worse outcomes in a daily i.v. busulfan and fludarabine allogeneic transplant regimen. Biol Blood Marrow Transplant 2008; 14: 220-228.
25. McCune JS, Gooley T, Gibbs JP, Sanders JE, Petersdorf EW, Appelbaum FR et al. Busulfan concentration and graft rejection in pediatric patients undergoing hematopoietic stem cell transplantation. Bone Marrow Transplant 2002; 30: 167-173. (Pubitemid 34993856)
26. Slattery JT, Clift RA, Buckner CD, Radich J, Storer B, Bensinger WI et al. Marrow transplantation for chronic myeloid leukemia: the influence of plasma busulfan levels on the outcome of transplantation. Blood 1997; 89: 3055-3060. (Pubitemid 27172594)
27. McDonald GB, Slattery JT, Bouvier ME, Ren S, Batchelder AL, Kalhorn TF et al. Cyclophosphamide metabolism, liver toxicity, and mortality following hematopoietic stem cell transplantation. Blood 2003; 101: 2043-2048. (Pubitemid 36237612)
28. Russell JA, Tran HT, Quinlan D, Chaudhry A, Duggan P, Brown C et al. Once-daily intravenous busulfan given with fludarabine as conditioning for allogeneic stem cell transplantation: study of pharmacokinetics and early clinical outcomes. Biol Blood Marrow Transplant 2002; 8: 468-476. (Pubitemid 35174820)
29. Andersson BS, de Lima M, Thall PF, Wang X, Couriel D, Korbling M et al. Once daily i.v. busulfan and fludarabine (i.v. Bu-Flu) compares favorably with i.v. busulfan and cyclophosphamide (i.v. BuCy2) as pretransplant conditioning therapy in AML/MDS. Biol Blood Marrow Transplant 2008; 14: 672-684. (Pubitemid 351664062)
30. Bredeson CN, Zhang MJ, Agovi MA, Bacigalupo A, Bahlis NJ, Ballen K et al. Outcomes following HSCT using fludarabine, busulfan, and thymoglobulin: a matched comparison to allogeneic transplants conditioned with busulfan and cyclophosphamide. Biol Blood Marrow Transplant 2008; 14: 993-1003.
31. Chae YS, Sohn SK, Kim JG, Cho YY, Moon JH, Shin HJ et al. New myeloablative conditioning regimen with fludarabine and busulfan for allogeneic stem cell transplantation: comparison with BuCy2. Bone Marrow Transplant 2007; 40: 541-547. (Pubitemid 47382124)
32. Slovak ML, Kopecky KJ, Cassileth PA, Harrington DH, Theil KS, Mohamed A et al. Karyotypic analysis predicts outcome of preremission and postremission therapy in adult acute myeloid leukemia: a Southwest Oncology Group/Eastern Cooperative Oncology Group Study. Blood 2000; 96: 4075-4083.
33. 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: 825-828.
34. Filipovich AH, Weisdorf D, Pavletic S, Socie G, Wingard JR, Lee SJ et al. National Institutes of Health consensus development project on criteria for clinical trials in chronic graft-versus-host disease: I. Diagnosis and staging working group report. Biol Blood Marrow Transplant 2005; 11: 945-956. (Pubitemid 41754712)
35. Gray R. A class of K-sample tests for comparing the cumulative incidence of a competing risk. Annals Of Statistics 1988; 16: 1141-1154.
36. Fine J. A proportional hazards model for the subdistribution of a competing risk. JASA 1999; 94: 496-509.
37. Perkins J, Field T, Kim J, Kharfan-Dabaja MA, Fernandez H, Ayala E 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 (e-pub ahead of print 23 January 2010).
38. Litzow MR, Perez WS, Klein JP, Bolwell BJ, Camitta B, Copelan EA et al. Comparison of outcome following allogeneic bone marrow transplantation with cyclophosphamide- total body irradiation versus busulphan-cyclophosphamide conditioning regimens for acute myelogenous leukaemia in first remission. Br J Haematol 2002; 119: 1115-1124. (Pubitemid 35463841)
39. Socie G, Clift RA, Blaise D, Devergie A, Ringden O, Martin PJ et al. Busulfan plus cyclophosphamide compared with totalbody irradiation plus cyclophosphamide before marrow transplantation for myeloid leukemia: long-term follow-up of 4 randomized studies. Blood 2001; 98: 3569-3574.
40. Wallen H, Gooley TA, Deeg HJ, Pagel JM, Press OW, Appelbaum FR et al. Ablative allogeneic hematopoietic cell transplantation in adults 60 years of age and older. J Clin Oncol 2005; 23: 3439-3446.
41. Martin PJ, McDonald GB, Sanders JE, Anasetti C, Appelbaum FR, Deeg HJ et al. Increasingly frequent diagnosis of acute gastrointestinal graft-vs-host disease after allogenic hematopoietic cell transplantation. Biol Blood Marrow Transplant 2004; 10: 320-327. (Pubitemid 38519570)
42. Horowitz MM, Gale RP, Sondel PM, Goldman JM, Kersey J, Kolb HJ et al. Graft-versus-leukemia reactions after bone marrow transplantation. Blood 1990; 75: 555-562. (Pubitemid 20069191)
43. Cassileth PA, Harrington DP, Appelbaum FR, Lazarus HM, Rowe JM, Paietta E et al. Chemotherapy compared with autologous or allogeneic bone marrow transplantation in the management of acute myeloid leukemia in first remission. N Engl J Med 1998; 339: 1649-1656. (Pubitemid 28550689)
44. Burnett AK, Wheatley K, Goldstone AH, Stevens RF, Hann IM, Rees JH et al. The value of allogeneic bone marrow transplant in patients with acute myeloid leukaemia at differing risk of relapse: results of the UK MRC AML 10 trial. Br J Haematol 2002; 118: 385-400. (Pubitemid 34994639)
45. Witherspoon RP, Deeg HJ, Storer B, Anasetti C, Storb R, Appelbaum FR. Hematopoietic stem-cell transplantation for treatment-related leukemia or myelodysplasia. J Clin Oncol 2001; 19: 2134-2141. (Pubitemid 32372322)
46. Weiden PL, Flournoy N, Thomas ED, Prentice R, Fefer A, Buckner CD et al. Antileukemic effect of graft-versus-host disease in human recipients of allogeneic-marrow grafts. N Engl J Med 1979; 300: 1068-1073. (Pubitemid 9198740)
47. Barrios M, Jimenez-Velasco A, Roman-Gomez J, Madrigal ME, Castillejo JA, Torres A et al. Chimerism status is a useful predictor of relapse after allogeneic stem cell transplantation for acute leukemia. Haematologica 2003; 88: 801-810. (Pubitemid 36896140)
48. Huisman C, de Weger RA, de Vries L, Tilanus MG, Verdonck LF. Chimerism analysis within 6 months of allogeneic stem cell transplantation predicts relapse in acute myeloid leukemia. Bone Marrow Transplant 2007; 39: 285-291. (Pubitemid 46322635)
49. Lamba R, Abella E, Kukuruga D, Klein J, Savasan S, Abidi MH et al. Mixed hematopoietic chimerism at day 90 following allogenic myeloablative stem cell transplantation is a predictor of relapse and survival. Leukemia 2004; 18: 1681-1686. (Pubitemid 39386347)
50. Michallet AS, Furst S, Le QH, Dubois V, Praire A, Nicolini F et al. Impact of chimaerism analysis and kinetics on allogeneic haematopoietic stem cell transplantation outcome after conventional and reduced-intensity conditioning regimens. Br J Haematol 2005; 128: 676-689. (Pubitemid 40343238)
51. Baron F, Sandmaier BM. Chimerism and outcomes after allogeneic hematopoietic cell transplantation following nonmyeloablative conditioning. Leukemia 2006; 20: 1690-1700. (Pubitemid 44590958)
52. Clift RA, Buckner CD, Appelbaum FR, Bearman SI, Petersen FB, Fisher LD et al. Allogeneic marrow transplantation in patients with acute myeloid leukemia in first remission: a randomized trial of two irradiation regimens. Blood 1990; 76: 1867-1871.
53. Jabbour E, Giralt S, Kantarjian H, Garcia-Manero G, Jagasia M, Kebriaei P et al. Low-dose azacitidine after allogeneic stem cell transplantation for acute leukemia. Cancer 2009; 115: 1899-1905.
54. Marks DI, Lush R, Cavenagh J, Milligan DW, Schey S, Parker A et al. The toxicity and efficacy of donor lymphocyte infusions given after reduced-intensity conditioning allogeneic stem cell transplantation. Blood 2002; 100: 3108-3114. (Pubitemid 35217056)