Dose Intensification of Busulfan in the Preparative Regimen is Associated with Improved Survival: A Phase I/II Controlled, Randomized Study

Biology of Blood and Marrow Transplantation

Volumn 19, Issue 3, 2013, Pages 474-480

  Parmar, Simrit ^a   Rondon, Gabriela ^a   de Lima, Marcos ^a   Thall, Peter ^a   Bassett, Ronald ^a   Anderlini, Paolo ^a   Kebriaei, Partow ^a   Khouri, Issa ^a   Ganesan, Prasanth ^a   Champlin, Richard ^a   Giralt, Sergio ^b  

^a UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER   (United States)

^b MEMORIAL SLOAN KETTERING CANCER CENTER   (United States)

Author keywords

Intravenous busulfan; Reduced intensity transplant; Relapsed refractory leukemia

Indexed keywords

BUSULFAN; FLUDARABINE;

AGED; ARTICLE; CONTROLLED STUDY; DRUG DOSE INTENSIFICATION; ENGRAFTMENT; FEMALE; FOLLOW UP; HUMAN; MALE; MORTALITY; OUTCOME ASSESSMENT; OVERALL SURVIVAL; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; POST TREATMENT SURVIVAL; PROGNOSIS; RANDOMIZED CONTROLLED TRIAL; RECURRENCE FREE SURVIVAL; RELAPSE; TREATMENT DURATION; TREATMENT RESPONSE;

ADMINISTRATION, ORAL; AGED; BUSULFAN; DRUG ADMINISTRATION SCHEDULE; FEMALE; GRAFT VS HOST DISEASE; HEMATOLOGIC NEOPLASMS; HEMATOPOIETIC STEM CELL TRANSPLANTATION; HISTOCOMPATIBILITY TESTING; HUMANS; IMMUNOSUPPRESSIVE AGENTS; INJECTIONS, INTRAVENOUS; MALE; MIDDLE AGED; MYELOABLATIVE AGONISTS; SURVIVAL ANALYSIS; TRANSPLANTATION CONDITIONING; TRANSPLANTATION, HOMOLOGOUS; VIDARABINE;

EID: 84873603965     PISSN: 10838791     EISSN: 15236536     Source Type: Journal    
DOI: 10.1016/j.bbmt.2012.12.001     Document Type: Article

References (32)

1. Aoudjhane M., Labopin M., Gorin N.C., 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.
2. Luger S.M., Ringden O., Zhang M.J., et al. Similar outcomes using myeloablative vs reduced-intensity allogeneic transplant preparative regimens for AML or MDS. Bone Marrow Transplant 2012, 47:203-211.
3. Ringden O., Labopin M., Ehninger G., et al. Reduced intensity conditioning compared with myeloablative conditioning using unrelated donor transplants in patients with acute myeloid leukemia. J Clin Oncol 2009, 27:4570-4577.
4. 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 2004, 104:857-864.
5. Wallen H., Gooley T.A., Deeg H.J., et al. Ablative allogeneic hematopoietic cell transplantation in adults 60 years of age and older. J Clin Oncol 2005, 23:3439-3446.
6. 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 2002, 8:145-154.
7. 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 1998, 91:756-763.
8. 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 2002, 8:493-500.
9. Alatrash G., de Lima M., Hamerschlak N., et al. Myeloablative reduced-toxicity i.v. busulfan-fludarabine and allogeneic hematopoietic stem cell transplant for patients with acute myeloid leukemia or myelodysplastic syndrome in the sixth through eighth decades of life. Biol Blood Marrow Transplant 2011, 17:1490-1496.
10. 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 2004, 104:865-872.
11. Martino R., Iacobelli S., Brand R., et al. Retrospective comparison of reduced-intensity conditioning and conventional high-dose conditioning for allogeneic hematopoietic stem cell transplantation using HLA-identical sibling donors in myelodysplastic syndromes. Blood 2006, 108:836-846.
12. Levine J.E., Uberti J.P., Ayash L., et al. Lowered-intensity preparative regimen for allogeneic stem cell transplantation delays acute graft-versus-host disease but does not improve outcome for advanced hematologic malignancy. Biol Blood Marrow Transplant 2003, 9:189-197.
13. 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 2005, 105:1810-1814.
14. Shimoni A., Hardan I., Shem-Tov N., 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.
15. Cahu X., Mohty M., Faucher C., et al. Outcome after reduced-intensity conditioning allogeneic SCT for AML in first complete remission: comparison of two regimens. Bone Marrow Transplant 2008, 42:689-691.
16. Hamadani M., Mohty M., Kharfan-Dabaja M.A. Reduced-intensity conditioning allogeneic hematopoietic cell transplantation in adults with acute myeloid leukemia. Cancer Control 2011, 18:237-245.
17. Przepiorka D., Weisdorf D., Martin P., et al. 1994 Consensus Conference on Acute GVHD Grading. Bone Marrow Transplant 1995, 15:825-828.
18. O'Quigley J., Pepe M., Fisher L. Continual reassessment method: a practical design for phase 1 clinical trials in cancer. Biometrics 1990, 46:33-48.
19. Goodman S.N., Zahurak M.L., Piantadosi S. Some practical improvements in the continual reassessment method for phase I studies. Stat Med 1995, 14:1149-1161.
20. Thall P.F., Simon R.M., Estey G.E. New statistical strategy for monitoring safety and efficacy in single-arm clinical trials. J Clin Oncol 1996, 14:296-303.
21. Gelman A.C.J., Stern H.S., Rubin D.B. Bayesian data analysis 1995, Chapman & Hall, New York, NY.
22. Schwarz Estimating the dimension of a model. Ann Stat 1978, 6:461-464.
23. Lunn D., Spiegelhalter D., Thomas A., Best N. The BUGS project: Evolution, critique and future directions (with discussion). Statistics in Medicine 2009, 28:3049-3082.
24. Prentice R.L., Kalbfleisch J.D., Peterson A.V., et al. The analysis of failure times in the presence of competing risks. Biometrics 1978, 34:541-554.
25. Fine J.P., Gray R.J. A proportional hazards model for the subdistribution of a competing risk. Journal of the American Statistical Association 1999, 94:496-509.
26. Parmar S., Andersson B.S., Couriel D., et al. Prophylaxis of graft-versus-host disease in unrelated donor transplantation with pentostatin, tacrolimus, and mini-methotrexate: a phase I/II controlled, adaptively randomized study. J Clin Oncol 2011, 29:294-302.
27. Leopold L.H., Willemze R. The treatment of acute myeloid leukemia in first relapse: a comprehensive review of the literature. Leuk Lymph 2002, 43:1715-1727.
28. Giles F., O'Brien S., Cortes J., et al. Outcome of patients with acute myelogenous leukemia after second salvage therapy. Cancer 2005, 104:547-554.
29. Sorror M.L., Maris M.B., Storb R., et al. Hematopoietic cell transplantation (HCT)-specific comorbidity index: a new tool for risk assessment before allogeneic HCT. Blood 2005, 106:2912-2919.
30. de Lima M., Giralt S., Thall P.F., et al. Maintenance therapy with low-dose azacitidine after allogeneic hematopoietic stem cell transplantation for recurrent acute myelogenous leukemia or myelodysplastic syndrome: a dose and schedule finding study. Cancer 2010, 116:5420-5431.
31. Jabbour E., Giralt S., Kantarjian H., et al. Low-dose azacitidine after allogeneic stem cell transplantation for acute leukemia. Cancer 2009, 115:1899-1905.
32. Marsh R.A., Vaughn G., Kim M.O., et al. Reduced-intensity conditioning significantly improves survival of patients with hemophagocytic lymphohistiocytosis undergoing allogeneic hematopoietic cell transplantation. Blood 2010, 116:5824-5831.