Randomized Comparison of Four-Times-Daily versus Once-Daily Intravenous Busulfan in Conditioning Therapy for Hematopoietic Cell Transplantation

Biology of Blood and Marrow Transplantation

Volumn 13, Issue 9, 2007, Pages 1095-1105

  Ryu, Seong Gil ^a   Lee, Je Hwan ^a   Choi, Seong Jun ^a   Lee, Jung Hee ^a   Lee, Young Shin ^a   Seol, Miee ^a   Hur, Eun Hye ^a   Lee, Soo Han ^a   Bae, Kyun Seop ^a   Noh, Gyu Jeong ^a   Lee, Moo Song ^a   Yun, Sung Cheol ^a   Han, Sang Beom ^b   Lee, Kyoo Hyung ^a  

^a University of Ulsan College of Medicine   (South Korea)

^b Chung Ang University   (South Korea)

Author keywords

Conditioning therapy; Hematopoietic cell transplantation; Intravenous busulfan; Once daily administration; Pharmacokinetics

Indexed keywords

ACICLOVIR; ALEMTUZUMAB; BUSULFAN; CIPROFLOXACIN; CYCLOPHOSPHAMIDE; CYCLOSPORIN; FLUDARABINE; GRANULOCYTE COLONY STIMULATING FACTOR; HEPARIN; IMMUNOGLOBULIN; LYMPHOCYTE ANTIBODY; MESNA; METHOTREXATE; PHENYTOIN; THYMOCYTE ANTIBODY;

ACUTE GRAFT VERSUS HOST DISEASE; ACUTE LYMPHOBLASTIC LEUKEMIA; ACUTE NONLYMPHOCYTIC LEUKEMIA; ADOLESCENT; ADULT; AREA UNDER THE CURVE; ARTICLE; BLEEDING; BLEEDING DISORDER; BLOOD CLOTTING DISORDER; BRAIN HEMORRHAGE; CARDIOTOXICITY; CHRONIC MYELOID LEUKEMIA; CLINICAL TRIAL; COMBINATION CHEMOTHERAPY; COMPARATIVE STUDY; CONSCIOUSNESS DISORDER; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DISSEMINATED INTRAVASCULAR CLOTTING; DRUG CLEARANCE; DRUG DOSE COMPARISON; DRUG ELIMINATION; DRUG HALF LIFE; DRUG WITHDRAWAL; EPISTAXIS; FEBRILE NEUTROPENIA; FEMALE; GASTROINTESTINAL HEMORRHAGE; GASTROINTESTINAL TOXICITY; HEART ARRHYTHMIA; HEMATOPOIETIC STEM CELL TRANSPLANTATION; HEMATURIA; HEMORRHAGIC CYSTITIS; HUMAN; HYDRATION; HYPERCALCEMIA; HYPERGLYCEMIA; HYPERKALEMIA; HYPERMAGNESEMIA; HYPERNATREMIA; HYPERTENSION; HYPOGLYCEMIA; HYPOKALEMIA; HYPOMAGNESEMIA; HYPONATREMIA; HYPOPHOSPHATEMIA; IMMUNOSUPPRESSIVE TREATMENT; INCIDENCE; INFECTION; KIDNEY FAILURE; LIVER TOXICITY; LIVER VENOOCCLUSIVE DISEASE; LOADING DRUG DOSE; LUNG TOXICITY; MAJOR CLINICAL STUDY; MALE; METABOLIC DISORDER; MONOTHERAPY; MORTALITY; NAUSEA AND VOMITING; NEPHROTOXICITY; NEUROTOXICITY; NEUTROPENIA; OVERALL SURVIVAL; PROTHROMBIN TIME; SEIZURE; SIDE EFFECT; STEM CELL MOBILIZATION; STOMATITIS; THROMBOTIC THROMBOCYTOPENIC PURPURA; TREATMENT RESPONSE; VIRUS INFECTION;

ADOLESCENT; ADULT; BUSULFAN; DRUG ADMINISTRATION SCHEDULE; FEMALE; GRAFT SURVIVAL; GRAFT VS HOST DISEASE; HEMATOPOIETIC STEM CELL TRANSPLANTATION; HEPATIC VENO-OCCLUSIVE DISEASE; HUMANS; MALE; MIDDLE AGED; PHARMACOKINETICS; SURVIVAL RATE; TRANSPLANTATION CONDITIONING;

EID: 34547683653     PISSN: 10838791     EISSN: 15236536     Source Type: Journal    
DOI: 10.1016/j.bbmt.2007.06.005     Document Type: Article

References (46)

1. Santos G.W., Tutschka P.J., Brookmeyer R., et al. Marrow transplantation for acute nonlymphocytic leukemia after treatment with busulfan and cyclophosphamide. N Engl J Med 309 (1983) 1347-1353
2. Tutschka P.J., Copelan E.A., and Klein J.P. Bone marrow transplantation for leukemia following a new busulfan and cyclophosphamide regimen. Blood 70 (1987) 1382-1388
3. Copelan E.A., and Deeg H.J. Conditioning for allogeneic marrow transplantation in patients with lymphohematopoietic malignancies without the use of total body irradiation. Blood 80 (1992) 1648-1658
4. Blaise D., Maraninchi D., Archimbaud E., et al. Allogeneic bone marrow transplantation for acute myeloid leukemia in first remission: a randomized trial of a busulfan-Cytoxan versus Cytoxan-total body irradiation as preparative regimen: a report from the Group d'Etudes de la Greffe de Moelle Osseuse. Blood 79 (1992) 2578-2582
5. Blume K.G., Kopecky K.J., Henslee-Downey J.P., et al. A prospective randomized comparison of total body irradiation-etoposide versus busulfan-cyclophosphamide as preparatory regimens for bone marrow transplantation in patients with leukemia who were not in first remission: a Southwest Oncology Group study. Blood 81 (1993) 2187-2193
6. Clift R.A., Buckner C.D., Thomas E.D., et al. Marrow transplantation for chronic myeloid leukemia: a randomized study comparing cyclophosphamide and total body irradiation with busulfan and cyclophosphamide. Blood 84 (1994) 2036-2043
7. Ringden O., Ruutu T., Remberger M., et al. A randomized trial comparing busulfan with total body irradiation as conditioning in allogeneic marrow transplant recipients with leukemia: a report from the Nordic Bone Marrow Transplantation Group. Blood 83 (1994) 2723-2730
8. Devergie A., Blaise D., Attal M., et al. Allogeneic bone marrow transplantation for chronic myeloid leukemia in first chronic phase: a randomized trial of busulfan-cytoxan versus cytoxan-total body irradiation as preparative regimen: a report from the French Society of Bone Marrow Graft (SFGM). Blood 85 (1995) 2263-2268
9. Hassan M., Ljungman P., Bolme P., et al. Busulfan bioavailability. Blood 84 (1994) 2144-2150
10. Schuler U., Schroer S., Kuhnle A., et al. Busulfan pharmacokinetics in bone marrow transplant patients: is drug monitoring warranted?. Bone Marrow Transplant 14 (1994) 759-765
11. Grochow L.B., Jones R.J., Brundrett R.B., et al. Pharmacokinetics of busulfan: correlation with veno-occlusive disease in patients undergoing bone marrow transplantation. Cancer Chemother Pharmacol 25 (1989) 55-61
12. Dix S.P., Wingard J.R., Mullins R.E., et al. Association of busulfan area under the curve with veno-occlusive disease following BMT. Bone Marrow Transplant 17 (1996) 225-230
13. Slattery J.T., Clift R.A., Buckner C.D., et al. Marrow transplantation for chronic myeloid leukemia: the influence of plasma busulfan levels on the outcome of transplantation. Blood 89 (1997) 3055-3060
14. Slattery J.T., Sanders J.E., Buckner C.D., et al. Graft-rejection and toxicity following bone marrow transplantation in relation to busulfan pharmacokinetics. Bone Marrow Transplant 16 (1995) 31-42
15. Peters W.P., Henner W.D., Grochow L.B., et al. Clinical and pharmacologic effects of high dose single agent busulfan with autologous bone marrow support in the treatment of solid tumors. Cancer Res 47 (1987) 6402-6406
16. Bhagwatwar H.P., Phadungpojna S., Chow D.S., and Andersson B.S. Formulation and stability of busulfan for intravenous administration in high-dose chemotherapy. Cancer Chemother Pharmacol 37 (1996) 401-408
17. Hassan Z., Ljungman P., Ringden O., et al. Pharmacokinetics of liposomal busulphan in man. Bone Marrow Transplant 27 (2001) 479-485
18. Olavarria E., Hassan M., Eades A., et al. A phase I/II study of multiple-dose intravenous busulfan as myeloablation prior to stem cell transplantation. Leukemia 14 (2000) 1954-1959
19. Andersson B.S., Madden T., Tran H.T., et al. Acute safety and pharmacokinetics of intravenous busulfan when used with oral busulfan and cyclophosphamide as pretransplantation conditioning therapy: a phase I study. Biol Blood Marrow Transplant 6 (2000) 548-554
20. Andersson B.S., Kashyap A., Gian V., et al. Conditioning therapy with intravenous busulfan and cyclophosphamide (IV BuCy2) for hematologic malignancies prior to allogeneic stem cell transplantation: a phase II study. Biol Blood Marrow Transplant 8 (2002) 145-154
21. Fernandez H.F., Tran H.T., Albrecht F., Lennon S., Caldera H., and Goodman M.S. Evaluation of safety and pharmacokinetics of administering intravenous busulfan in a twice-daily or daily schedule to patients with advanced hematologic malignant disease undergoing stem cell transplantation. Biol Blood Marrow Transplant 8 (2002) 486-492
22. Andersson B.S., Gajewski J., Donato M., et al. Allogeneic stem cell transplantation (BMT) for AML and MDS following i.v. busulfan and cyclophosphamide (i.v. BuCy). Bone Marrow Transplant 25 Suppl 2 (2000) S35-S38
23. Deeg H.J., Schuler U.S., Shulman H., et al. Myeloablation by intravenous busulfan and hematopoietic reconstitution with autologous marrow in a canine model. Biol Blood Marrow Transplant 5 (1999) 316-321
24. Shaw P.J., Scharping C.E., Brian R.J., and Earl J.W. Busulfan pharmacokinetics using a single daily high-dose regimen in children with acute leukemia. Blood 84 (1994) 2357-2362
25. De Lima M., Couriel D., Thall P.F., et al. Once daily intravenous busulfan and fludarabine: clinical and pharmacokinetic results of a myeloablative, reduced toxicity conditioning regimen for allogeneic stem cell transplantation in AML and MDS. Blood 104 (2004) 857-864
26. Russell J.A., Tran H.T., Quinlan D., 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 8 (2002) 468-476
27. Choi S.J., Lee K.H., Lee J.H., et al. Prognostic value of hematopoietic chimerism in patients with acute leukemia after allogeneic bone marrow transplantation: a prospective study. Bone Marrow Transplant 26 (2000) 327-332
28. Tutschka P.J., Beschorner W.E., Hess A.D., and Santos G.W. Cyclosporin-A to prevent graft-versus-host disease: a pilot study in 22 patients receiving allogeneic marrow transplants. Blood 61 (1983) 318-325
29. Przepiorka D., Khouri I., Ippoliti C., et al. Tacrolimus and minidose methotrexate for prevention of acute graft-versus-host disease after HLA-mismatched marrow or blood stem cell transplantation. Bone Marrow Transplant 24 (1999) 763-768
30. McDonald G.B., Hinds M.S., Fisher L.D., et al. Veno-occlusive disease of the liver and multiorgan failure after bone marrow transplantation: a cohort study of 355 patients. Ann Intern Med 118 (1993) 255-267
31. Bearman S.I. The syndrome of hepatic veno-occlusive disease after marrow transplantation. Blood 85 (1995) 3005-3020
32. Gleaves C.A., Smith T.F., Shuster E.A., and Pearson G.R. Comparison of standard tube and shell vial cell culture techniques for the detection of cytomegalovirus in clinical specimens. J Clin Microbiol 21 (1985) 217-221
33. Pancholi P., Wu F., and Della-Latta P. Rapid detection of cytomegalovirus infection in transplant patients. Expert Rev Mol Diagn 4 (2004) 231-242
34. St George K., and Rinaldo Jr. C.R. Comparison of cytomegalovirus antigenemia and culture assays in patients on and off antiviral therapy. J Med Virol 59 (1999) 91-97
35. Vaughan W.P., Carey D., Perry S., Westfall A.O., and Salzman D.E. A limited sampling strategy for pharmacokinetic directed therapy with intravenous busulfan. Biol Blood Marrow Transplant 8 (2002) 619-624
36. Gray R.J. A class of K-sample tests for comparing the cumulative incidence of a completing risk. Ann Stat 16 (1988) 1141-1154
37. Kashyap A., Wingard J., Cagnoni P., et al. Intravenous versus oral busulfan as part of a busulfan/cyclophosphamide preparative regimen for allogeneic hematopoietic stem cell transplantation: decreased incidence of hepatic venoocclusive disease (HVOD), HVOD-related mortality, and overall 100-day mortality. Biol Blood Marrow Transplant 8 (2002) 493-500
38. Kim S.E., Lee J.H., Choi S.J., Lee J.H., Ryu S.G., and Lee K.H. Morbidity and non-relapse mortality after allogeneic bone marrow transplantation in adult leukemia patients conditioned with busulfan plus cyclophosphamide: a retrospective comparison of oral versus intravenous busulfan. Haematologica 90 (2005) 285-286
39. Lee J.H., Choi S.J., Lee J.H., et al. Decreased incidence of hepatic veno-occlusive disease and fewer hemostatic derangements associated with intravenous busulfan vs oral busulfan in adults conditioned with busulfan + cyclophosphamide for allogeneic bone marrow transplantation. Ann Hematol 84 (2005) 321-330
40. Vassal G., Deroussent A., Hartmann O., et al. Dose-dependent neurotoxicity of high-dose busulfan in children: a clinical and pharmacological study. Cancer Res 50 (1990) 6203-6207
41. McCune J.S., Gooley T., Gibbs J.P., et al. Busulfan concentration and graft rejection in pediatric patients undergoing hematopoietic stem cell transplantation. Bone Marrow Transplant 30 (2002) 167-173
42. Ljungman P., Hassan M., Bekassy A.N., Ringden O., and Oberg G. High busulfan concentrations are associated with increased transplant-related mortality in allogeneic bone marrow transplant patients. Bone Marrow Transplant 20 (1997) 909-913
43. Deeg H.J., Storer B., Slattery J.T., et al. Conditioning with targeted busulfan and cyclophosphamide for hemopoietic stem cell transplantation from related and unrelated donors in patients with myelodysplastic syndrome. Blood 100 (2002) 1201-1207
44. Tran H., Petropoulos D., Worth L., et al. Pharmacokinetics and individualized dose adjustment of intravenous busulfan in children with advanced hematologic malignancies undergoing allogeneic stem cell transplantation. Biol Blood Marrow Transplant 10 (2004) 805-812
45. Andersson B.S., Thall P.F., Madden T., et al. Busulfan systemic exposure relative to regimen-related toxicity and acute graft-versus-host disease: defining a therapeutic window for i.v. BuCy2 in chronic myelogenous leukemia. Biol Blood Marrow Transplant 8 (2002) 477-485
46. Kusama M., Kubota T., Matsukura Y., et al. Influence of glutathione S-transferase A1 polymorphism on the pharmacokinetics of busulfan. Clin Chim Acta 368 (2006) 93-98