Intravenous Busulfan-Based Myeloablative Conditioning Regimens Prior to Hematopoietic Cell Transplantation for Hematologic Malignancies

Biology of Blood and Marrow Transplantation

Volumn 22, Issue 8, 2016, Pages 1424-1430

  Pasquini, Marcelo C ^a   Le Rademacher, Jennifer ^a   Zhu, Xiaochun ^a   Artz, Andrew ^b   DiPersio, John ^c   Fernandez, Hugo F ^d   Mineishi, Shin ^e   Kamishohara, Masaru ^f   Mehta, Jayesh ^g   Nakamura, Yuki ^f   Ratanatharathorn, Voravit ^h,i   Sobecks, Ronald ^j   Burkart, Jeanne ^a   Bredeson, Christopher ^k  

^a MEDICAL COLLEGE OF WISCONSIN   (United States)

^b UNIVERSITY OF CHICAGO   (United States)

^c BARNES JEWISH HOSPITAL   (United States)

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

^e UNIVERSITY OF ALABAMA AT BIRMINGHAM   (United States)

^f OTSUKA PHARMACEUTICAL CO LTD   (Japan)

^g NORTHWESTERN MEMORIAL HOSPITAL   (United States)

^h WAYNE STATE UNIVERSITY   (United States)

ⁱ JP McCarthy Cord Stem Cell Bank ^*  (United States)

^j LERNER RESEARCH INSTITUTE   (United States)

^k OTTAWA HOSPITAL RESEARCH INSTITUTE   (Canada)

more..

Author keywords

Busulfan; Fludarabine; Myeloablative

Indexed keywords

BUSULFAN; CYCLOPHOSPHAMIDE; FLUDARABINE; METHOTREXATE; TACROLIMUS; ANTINEOPLASTIC AGENT; MYELOABLATIVE AGENT; VIDARABINE;

ACUTE GRAFT VERSUS HOST DISEASE; ACUTE MYELOBLASTIC LEUKEMIA; ADOLESCENT; ADULT; ARTICLE; CHILD; CHRONIC GRAFT VERSUS HOST DISEASE; CHRONIC MYELOID LEUKEMIA; CLINICAL ASSESSMENT; COHORT ANALYSIS; CONTROLLED STUDY; DISEASE FREE SURVIVAL; FEMALE; FOLLOW UP; GRAFT RECIPIENT; HEMATOPOIETIC STEM CELL TRANSPLANTATION; HUMAN; IDIOPATHIC DISEASE; INCIDENCE; MAJOR CLINICAL STUDY; MALE; MORTALITY; MULTICENTER STUDY; MYELOABLATIVE CONDITIONING; MYELODYSPLASTIC SYNDROME; OUTCOME ASSESSMENT; OVERALL SURVIVAL; PNEUMONIA; PROSPECTIVE STUDY; RELAPSE; SEIZURE; VEIN OCCLUSION; WHOLE BODY RADIATION; ALLOTRANSPLANTATION; ANALOGS AND DERIVATIVES; CLINICAL TRIAL; DRUG ADMINISTRATION; HEMATOLOGIC DISEASE; INFANT; LIVER VEIN OBSTRUCTION; MIDDLE AGED; PRESCHOOL CHILD; PROCEDURES; TRANSPLANTATION CONDITIONING; TREATMENT OUTCOME; YOUNG ADULT;

ADOLESCENT; ADULT; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BUSULFAN; CHILD; CHILD, PRESCHOOL; CYCLOPHOSPHAMIDE; DRUG ADMINISTRATION SCHEDULE; FEMALE; HEMATOLOGIC NEOPLASMS; HEMATOPOIETIC STEM CELL TRANSPLANTATION; HEPATIC VENO-OCCLUSIVE DISEASE; HUMANS; INFANT; MALE; MIDDLE AGED; MYELOABLATIVE AGONISTS; PNEUMONIA; PROSPECTIVE STUDIES; SEIZURES; TRANSPLANTATION CONDITIONING; TRANSPLANTATION, HOMOLOGOUS; TREATMENT OUTCOME; VIDARABINE; YOUNG ADULT;

EID: 84981328222     PISSN: 10838791     EISSN: 15236536     Source Type: Journal    
DOI: 10.1016/j.bbmt.2016.04.013     Document Type: Article

References (34)

1. 1 Bhagwatwar, H.P., Phadungpojna, S., Chow, D.S., Andersson, B.S., Formulation and stability of busulfan for intravenous administration in high-dose chemotherapy. Cancer Chemother Pharmacol 37 (1996), 401–408.
2. 2 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.
3. 3 Tutschka, P.J., Copelan, E.A., Klein, J.P., Bone marrow transplantation for leukemia following a new busulfan and cyclophosphamide regimen. Blood 70 (1987), 1382–1388.
4. 4 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.
5. 5 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.
6. 6 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.
7. 7 Madden, T., de Lima, M., Thapar, N., et al. Pharmacokinetics of once-daily intravenous busulfan as part of pretransplantation preparative regimens: a comparison with an every 6-hour dosing schedule. Biol Blood Marrow Transplant 13 (2007), 56–64.
8. 8 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.
9. 9 Andersson, B.S., de Lima, M., Thall, P.F., 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 14 (2008), 672–684.
10. 10 Bartelink, I.H., van Reij, E.M.L., Gerhardt, C.E., et al. Fludarabine and exposure-targeted busulfan compares favorably with busulfan/cyclophosphamide-based regimens in pediatric hematopoietic cell transplantation: maintaining efficacy with less toxicity. Biol Blood Marrow Transplant 20 (2014), 345–353.
11. 11 Chae, Y.S., Sohn, S.K., Kim, J.G., et al. New myeloablative conditioning regimen with fludarabine and busulfan for allogeneic stem cell transplantation: comparison with BuCy2. Bone Marrow Transplant 40 (2007), 541–547.
12. 12 Bredeson, C.N., Zhang, M.J., Agovi, M.A., 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 14 (2008), 993–1003.
13. 13 Lee, J.H., Joo, Y.D., Kim, H., et al. Randomized trial of myeloablative conditioning regimens: busulfan plus cyclophosphamide versus busulfan plus fludarabine. J Clin Oncol 31 (2013), 701–709.
14. 14 Liu, D.H., Xu, L.P., Zhang, X.H., et al. Substitution of cyclophosphamide in the modified BuCy regimen with fludarabine is associated with increased incidence of severe pneumonia: a prospective, randomized study. Int J Hematol 98 (2013), 708–715.
15. 15 Rambaldi, A., Grass, A., Masciulli, A., et al. Busulfan plus cycophosphamide versus bulsulfan plus fludarabine as a perparative regimen for allogeneic hematopoietic stem-cell transplantation in patients with acute myeloid leukemia: an open-label, multicentre, ransomised, phase 3 trial. Lancet Oncol 15 (2015), 1525–1536.
16. 16 Bredeson, C., LeRademacher, J., Kato, K., et al. Prospective cohort study comparing intravenous busulfan to total body irradiation in hematopoietic cell transplantation. Blood 122 (2013), 3871–3878.
17. 17 Pasquini, M., Wang, Z., Horowitz, M.M., Gale, R.P., 2013 report from the Center for International Blood and Marrow Transplant Research (CIBMTR): current uses and outcomes of hematopoietic cell transplants for blood and bone marrow disorders. Clin Transpl, 2013, 187–197.
18. 18 Bacigalupo, A., Ballen, K., Rizzo, D., et al. Defining the intensity of conditioning regimens: working definitions. Biol Blood Marrow Transplant 15 (2009), 1628–1633.
19. 19 Giralt, S., Ballen, K., Rizzo, R., et al. Reduced-intensity conditioning regimen workshop: defining the dose spectrum. Report of a workshop convened by the Center for International Blood and Marrow Transplant Research. Biol Blood Marrow Transplant 15 (2009), 367–369.
20. 20 Klein, J.P., Moeschberger, M.L., Survival analysis: techniques for censored and truncated data. 2003, Springer-Verlag, New York.
21. 21 Copelan, E.A., 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.
22. 22 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.
23. 23 Hassan, M., Ljungman, P., Bolme, P., et al. Busulfan bioavailability. Blood 84 (1994), 2144–2150.
24. 24 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.
25. 25 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.
26. 26 Sato, M., Kako, S., Matsumoto, K., et al. Pharmacokinetics study of once-daily intravenous busulfan in conditioning regimens for hematopoietic stem cell transplantation. Int J Hematol 101 (2015), 497–504.
27. 27 Clemmons, A.B., Evans, S., DeRemer, D.L., Awan, F.T., Busulfan dosing (Q6 or Q24) with adjusted or actual body weight, does it matter?. J Oncol Pharm Pract 21 (2015), 425–432.
28. 28 Gandhi, V., Plunkett, W., Cellular and clinical pharmacology of fludarabine. Clin Pharmacokinet 41 (2002), 93–103.
29. 29 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.
30. 30 Bornhauser, M., Storer, B., Slattery, J.T., et al. Conditioning with fludarabine and targeted busulfan for transplantation of allogeneic hematopoietic stem cells. Blood 102 (2003), 820–826.
31. 31 Perkins, J.B., Kim, J., Anasetti, C., et al. Maximally tolerated busulfan systemic exposure in combination with fludarabine as conditioning before allogeneic hematopoietic cell transplantation. Biol Blood Marrow Transplant 18 (2012), 1099–1107.
32. 32 Mohty, M., Malard, F., Blaise, D., et al. Reduced-toxicity conditioning with fludarabine, once-daily intravenous busulfan, and antithymocyte globulins prior to allogeneic stem cell transplantation: results of a multicenter prospective phase 2 trial. Cancer 121 (2015), 562–569.
33. 33 Russell, J.A., Kangarloo, S.B., Williamson, T., et al. Establishing a target exposure for once-daily intravenous busulfan given with fludarabine and thymoglobulin before allogeneic transplantation. Biol Blood Marrow Transplant 19 (2013), 1381–1386.
34. 34 Hassan, M., Andersson, B.S., Role of pharmacogenetics in busulfan/cyclophosphamide conditioning therapy prior to hematopoietic stem cell transplantation. Pharmacogenomics 14 (2013), 75–87.