A practical guide to therapeutic drug monitoring in busulfan: recommendations from the Pharmacist Committee of the European Society for Blood and Marrow Transplantation (EBMT)

Ciurea SO, Andersson BS. Busulfan in hematopoietic stem cell transplantation. Biol Blood Marrow Transpl. 2009;15:523–36.

Article  CAS  Google Scholar 

Santos GW, Tutschka PJ, Brookmeyer R, Saral R, Beschorner WE, Bias WB, et al. Marrow transplantation for acute nonlymphocytic leukemia after treatment with busulfan and cyclophosphamide. N Engl J Med. 1983;309:1347–53.

Article  CAS  PubMed  Google Scholar 

Socié G, Clift RA, Biaise D, Devergie A, Ringden O, Martin PJ, et al. Busulfan plus cyclophosphamide compared with total-body irradiation plus cyclophosphamide before marrow transplantation for myeloid leukemia: long-term follow-up of 4 randomized studies. Blood. 2001;98:3569–74.

Article  PubMed  Google Scholar 

Bashir Q, Thall PF, Milton DR, Fox PS, Kawedia JD, Kebriaei P, et al. Conditioning with busulfan plus melphalan versus melphalan alone before autologous haemopoietic cell transplantation for multiple myeloma: an open-label, randomised, phase 3 trial. Lancet Haematol. 2019;6:e266–e275.

Article  PubMed  PubMed Central  Google Scholar 

Kharfan-Dabaja MA, Labopin M, Bazarbachi A, Hamladji RM, Blaise D, Socié G, et al. Comparing i.v. BU dose intensity between two regimens (FB2 vs FB4) for allogeneic HCT for AML in CR1: a report from the Acute Leukemia Working Party of EBMT. Bone Marrow Transpl. 2014;49:1170–5.

Article  CAS  Google Scholar 

Kröger N, Holler E, Kobbe G, Bornhäuser M, Schwerdtfeger R, Baurmann H, et al. Allogeneic stem cell transplantation after reduced-intensity conditioning in patients with myelofibrosis: A prospective, multicenter study of the Chronic LeukemiaWorking Party of the European Group for Blood and Marrow Transplantation. Blood. 2009;114:5264–70.

Article  PubMed  Google Scholar 

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 Transpl. 2008;14:672–84.

Article  CAS  Google Scholar 

Myers AL, Kawedia JD, Champlin RE, Kramer MA, Nieto Y, Ghose R, et al. Clarifying busulfan metabolism and drug interactions to support new therapeutic drug monitoring strategies: a comprehensive review. Expert Opin Drug Metab Toxicol. 2017;13:901–23.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Marsit H, Philippe M, Neely M, Rushing T, Bertrand Y, Ducher M, et al. Intra-individual pharmacokinetic variability of intravenous busulfan in hematopoietic stem cell-transplanted children. Clin Pharmacokinet. 2020;59:1049–61.

Article  CAS  PubMed  Google Scholar 

McCune JS, Holmberg LA. Busulfan in hematopoietic stem cell transplant setting. Expert Opin Drug Metab Toxicol. 2009;5:957–69.

Article  CAS  PubMed  Google Scholar 

Palmer J, McCune JS, Perales M, Marks D, Bubalo J, Mohty M, et al. Personalizing busulfan-based conditioning: considerations from the American Society for Blood and Marrow Transplantation Practice Guidelines Committee. Biol Blood Marrow Transpl. 2016;22:1915–25.

Article  CAS  Google Scholar 

Andersson BS, Thall PF, Valdez BC, Milton DR, Al-Atrash G, Chen J, et al. Fludarabine with pharmacokinetically guided IV busulfan is superior to fixed-dose delivery in pretransplant conditioning of AML/MDS patients. Bone Marrow Transpl. 2017;52:580–7.

Article  CAS  Google Scholar 

Bartelink IH, Lalmohamed A, van Reij EML, Dvorak CC, Savic RM, Zwaveling J, et al. Association of busulfan exposure with survival and toxicity after haemopoietic cell transplantation in children and young adults: a multicentre, retrospective cohort analysis. Lancet Haematol. 2016;3:e526–e536.

Article  PubMed  PubMed Central  Google Scholar 

Klyuchnikov E, Langebrake C, Badbaran A, Dadkhah A, Massoud R, Freiberger P, et al. Individualized busulfan dosing improves outcomes compared to fixed-dose administration in pre-transplant minimal residual disease-positive acute myeloid leukemia patients with intermediate-risk undergoing allogeneic stem cell transplantation in CR. Eur J Haematol. 2023;110:188–97.

Article  CAS  PubMed  Google Scholar 

Pidala J, Kim J, Anasetti C, Kharfan-Dabaja MA, Nishihori T, Field T, et al. Pharmacokinetic targeting of intravenous busulfan reduces conditioning regimen related toxicity following allogeneic hematopoietic cell transplantation for acute myelogenous leukemia. J Hematol Oncol. 2010;3:7–15.

Article  Google Scholar 

Feng X, Wu Y, Zhang J, Li J, Zhu G, Fan D, et al. Busulfan systemic exposure and its relationship with efficacy and safety in hematopoietic stem cell transplantation in children: a meta-analysis. BMC Pediatr. 2020;20:1–11.

Article  Google Scholar 

Ruutu T, van der Werf S, van Biezen A, Backman JT, Peczynski C, Kröger N, et al. Use of busulfan in conditioning for allogeneic hematopoietic stem cell transplantation in adults: a survey by the transplant complications working party of the EBMT. Bone Marrow Transpl. 2019;54:2013–9.

Article  CAS  Google Scholar 

Essmann S, Dadkhah A, Janson D, Wolschke C, Ayuk F, Kröger NM, et al. Iron chelation with deferasirox increases busulfan AUC during conditioning chemotherapy prior to allogeneic stem cell transplantation. Transpl Cell Ther. 2022;28:115.e1–115.e5.

Article  CAS  Google Scholar 

Langebrake C, Admiraal R, van Maarseveen E, Bonnin A, Bauters T, Bauters T, et al. Consensus recommendations for the role and competencies of the EBMT clinical pharmacist and clinical pharmacologist involved in hematopoietic stem cell transplantation. Bone Marrow Transpl. 2020;55:62–69.

Article  Google Scholar 

Langenhorst JB, Boss J, van Kesteren C, Lalmohamed A, Kuball J, Egberts ACG, et al. A semi-mechanistic model based on glutathione depletion to describe intra-individual reduction in busulfan clearance. Br J Clin Pharm. 2020;86:1499–509.

Article  CAS  Google Scholar 

Hassan M, Öberg G, Ehrsson H, Ehrnebo M, Wallin I, Smedmyr B, et al. Pharmacokinetic and metabolic studies of high-dose busulphan in adults. Eur J Clin Pharm. 1989;36:525–30.

Article  CAS  Google Scholar 

Hassan M, Ehrsson H, Smedmyr B, Tötterman T, Wallin I, Oberg G, et al. Cerebrospinal fluid and plasma concentrations of busulfan during high-dose therapy. Bone Marrow Transpl. 1989;4:113–4.

CAS  Google Scholar 

Vassal G, Deroussent A, Hartmann O, Challine D, Benhamou E, Valteau-Couanet D, et al. Dose-dependent neurotoxicity of high-dose busulfan in children: a clinical and pharmacological study. Cancer Res. 1990;50:6203–7.

CAS  PubMed  Google Scholar 

Akiyama K, Kume T, Fukaya M, Shiki I, Enami T, Tatara R, et al. Comparison of levetiracetam with phenytoin for the prevention of intravenous busulfan-induced seizures in hematopoietic cell transplantation recipients. Cancer Chemother Pharm. 2018;82:717–21.

Article  CAS  Google Scholar 

Czerwinski M, Gibbs P, Slattery T. Busulfan conjugation by glutathione s-transferase alpha, mu and pi. Drug Metab Dispos. 1996;24:1015–9.

CAS  PubMed  Google Scholar 

Gibbs JP, Liacouras CA, Baldassano RN, Slattery JT. Up-regulation of glutathione S-transferase activity in enterocytes of young children. Drug Metab Dispos. 1999;27:1466–9.

CAS  PubMed  Google Scholar 

El-Serafi I, Terelius Y, Abedi-Valugerdi M, Naughton S, Saghafian M, Moshfegh A, et al. Flavin-containing monooxygenase 3 (FMO3) role in busulphan metabolic pathway. PLoS ONE. 2017;12:1–17.

Article  Google Scholar 

Uppugunduri CRS, Rezgui MA, Diaz PH, Tyagi AK, Rousseau J, Daali Y, et al. The association of cytochrome P450 genetic polymorphisms with sulfolane formation and the efficacy of a busulfan-based conditioning regimen in pediatric patients undergoing hematopoietic stem cell transplantation. Pharmacogenomics J. 2014;14:263–71.

Article  CAS  PubMed  Google Scholar 

Ansari M, Curtis PHD, Uppugunduri CRS, Rezgui MA, Nava T, Mlakar V, et al. GSTA1 diplotypes affect busulfan clearance and toxicity in children undergoing allogeneic hematopoietic stem cell transplantation: a multicenter study. Oncotarget. 2017;8:90852–67.

Article  PubMed  PubMed Central  Google Scholar 

Shukla P, Goswami S, Keizer RJ, Winger BA, Kharbanda S, Dvorak CC, et al. Assessment of a model-informed precision dosing platform use in routine clinical care for personalized busulfan therapy in the pediatric Hematopoietic Cell Transplantation (HCT) population. Front Pharm. 2020;11:1–8.

Article  Google Scholar 

Ben Hassine K, Seydoux C, Khier S, Daali Y, Medinger M, Halter J, et al. Pharmacokinetic modeling and simulation with pharmacogenetic insights support the relevance of therapeutic drug monitoring for myeloablative busulfan dosing in Adult HSCT. Transpl Cell Ther. 2024;30:332.e1–332.e15.

Article  Google Scholar 

Takahashi T, Jaber MM, Brown SJ, Al-Kofahi M. Population pharmacokinetic model of intravenous busulfan in hematopoietic cell transplantation: systematic review and comparative simulations. Clin Pharmacokinet. 2023;62:955–68.

Article  CAS  PubMed  Google Scholar 

Bognàr TT, Kingma JSJ, Smeijsters EHE, van der Elst KCMK, de Kanter CTMK, Lindemans CAC, et al. Busulfan target exposure attainment in children undergoing allogeneic hematopoietic cell transplantation: a single day versus a multiday therapeutic drug monitoring regimen. Bone Marrow Transpl. 2023;58:762–8.

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