Influence on Busilvex® pharmacokinetics of clonazepam compared to previous phenytoin historical data

Anticancer Research

Volumn 30, Issue 7, 2010, Pages 2977-2984

  Carreras, E ^a   Cahn, J Y ^b   Puozzo, C ^c   Kroger N ^d   Sanz, G ^e   Buzyn, A ^f   Bacigalupo, A ^g   Vernant, J P ^h  

^a Institute of Hematology Oncology   (Spain)

^b GRENOBLE UNIVERSITY HOSPITAL   (France)

^c Hôtel Dieu St Jacques   (France)

^d UNIVERSITY MEDICAL CENTER HAMBURG EPPENDORF   (Germany)

^e HOSPITAL UNIVERSITARIO LA FE   (Spain)

^f HÔPITAL NECKER ENFANTS MALADES   (France)

^g UNIVERSITY OF GENOA   (Italy)

^h PITIÉ SALPÊTRIÈRE HOSPITAL   (France)

Author keywords

Benzodiazepines; Busulfan; Metabolism induction; Pharmacokinetics; Phenytoin; Seizure prophylaxis

Indexed keywords

BUSULFAN; CLONAZEPAM; CYCLOPHOSPHAMIDE; PHENYTOIN; ALKYLATING AGENT; ANTICONVULSIVE AGENT; IMMUNOSUPPRESSIVE AGENT;

ACUTE GRANULOCYTIC LEUKEMIA; ADULT; ARTICLE; BONE MARROW TRANSPLANTATION; CHRONIC MYELOID LEUKEMIA; CLINICAL ARTICLE; CLINICAL ASSESSMENT; CLINICAL TRIAL; CONDITIONING; CONTINUOUS INFUSION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG EXPOSURE; DRUG METABOLISM; FEMALE; HEMATOPOIETIC STEM CELL TRANSPLANTATION; HUMAN; LYMPHOMA; MALE; MYELODYSPLASTIC SYNDROME; PATIENT SAFETY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SEIZURE; UNSPECIFIED SIDE EFFECT; ADOLESCENT; BLOOD; BLOOD DISEASE; DRUG INTERACTION; IMMUNOSUPPRESSIVE TREATMENT; METABOLISM; METHODOLOGY; MIDDLE AGED; MULTICENTER STUDY; PROSPECTIVE STUDY;

ADOLESCENT; ADULT; ALKYLATING AGENTS; ANTICONVULSANTS; BUSULFAN; CLONAZEPAM; CYCLOPHOSPHAMIDE; DRUG INTERACTIONS; FEMALE; HEMATOLOGIC NEOPLASMS; HEMATOPOIETIC STEM CELL TRANSPLANTATION; HUMANS; IMMUNOSUPPRESSIVE AGENTS; MALE; MIDDLE AGED; PHENYTOIN; PROSPECTIVE STUDIES; SEIZURES; TRANSPLANTATION CONDITIONING; YOUNG ADULT;

EID: 77955806660     PISSN: 02507005     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (64)

1. Bortin MM, Horowitz MM and Rimm AA: Increasing utilization of allogeneic bone marrow transplantation. Results of the 1988-1990 Survey. Ann InternMed 116(6): 505-512, 1992.
2. Przepiorka D, Khouri I, Thall P, Mehra R, Lee MS, Ippoliti C, Giralt S, Gajewski J, van Besien K, Andersson B, Korbling M, Deisseroth AB and Champlin R: Thiotepa, busulfan and cyclophosphamide as a preparative regimen for allogeneic transplantation for advanced chronic myelogenous leukemia. Bone Marrow Transplant 23(10): 977-981, 1999.
3. Santos GW: The development of busulfan/cyclophosphamide preparative regimens. Semin Oncol 20(4 Suppl 4): 12-6, 1993.
4. Schwarer AP, Opat SS, Watson AL and Cole-Sinclair MF: Clobazam for seizure prophylaxis during busulfan chemotherapy. Lancet 346(8984): 1238, 1995.
5. Socie G, Clift RA, Blaise D, Devergie A, Ringden O, Martin PJ, Remberger M, Deeg HJ, Ruutu T, Michallet M, Sullivan KM and Chevret S: 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 98(13): 3569-3574, 2001.
6. Thomas ED: Bone marrow transplantation: a review. Semin Hematol 36(4 Suppl 7): 95-103, 1999.
7. Thomas ED and Storb R: The Development of the Scientific Foundation of Hematopoietic Cell Transplantation Based on Animal and Human Studies. Blackwell Science 1999. Thomas ED, Blume KG and Forman SJ.
8. Albrecht M, Tackmann W and Pribilla W: Aplastic Syndrome in Myleran Overdose. Med Klin 66(4): 126-30, 1971 (in German).
9. Asano M, Odell TT Jr, McDonald TP and Upton AC: Radiomimetic agents and X-rays in mice and AET protectiveness. Comparative pathological effects. ArchPathol 75: 250-263, 1963.
10. Brookes P and Lawley PD: The reaction of mono- and difunctional alkylating agents with nucleic acids. Biochem J 80(3): 496-503, 1961.
11. Roberts JJ and Warwick GP: The mode of action of alkylating agents-III: The formation of 3-hydroxytetrahydrothiophene-1:1-dioxide from 1:4-dimethanesulphonyloxybutane (myleran), S-β-1- alanyltetrahydrothiophenium mesylate, tetrahydro-thiophene and tetrahydrothiophene-1:1-dioxide in the rat, rabbit and mouse. Biochem Pharmacol 6(4): 217-220, 1961.
12. Clift RA, Buckner CD, Thomas ED, Bensinger WI, Bowden R, Bryant E, Deeg HJ, Doney KC, Fisher LD and Hansen JA: Marrow transplantation for chronic myeloid leukemia: a randomized study comparing cyclophosphamide and total body irradiation with busulfan and cyclophosphamide. Blood 84(6): 2036-2043, 1994.
13. Clift RA, Radich J, Appelbaum FR, Martin P, Flowers ME, Deeg HJ, Storb R and Thomas ED: Long-term follow-up of a randomized study comparing cyclophosphamide and total body irradiation with busulfan and cyclophosphamide for patients receiving allogenic marrow transplants during chronic phase of chronic myeloid leukemia. Blood 94: 3960-3962, 1999.
14. Ringden O, Ruutu T, Remberger M, Nikoskelainen J, Volin L, Vindelov L, Parkkali T, Lenhoff S, Sallerfors B and Ljungman P: A randomized trial comparing busulfan vs. total-body irradiation in allogeneic marrow transplant recipients with hematological malignancies. Transplant Proc 26(3): 1831-1832, 1994.
15. Tutshka PJ, Copelan EA and Klein JP: Bone marrow transplantation for leukemia following a new busulfan and cyclophosphamide regimen. Blood 70(5): 1382-1388, 1987. (Pubitemid 18026142)
16. Andersson BS, Madden T, Tran HT, Hu WW, Blume KG, Chow DS, Champlin RE and Vaughan WP: 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(5A): 548-554, 2000.
17. Leger F, Nguyen L and Puozzo C: Exposure equivalence between i.v. (0.8 mg/kg) and oral (1 mg/kg) busulfan in adult patients. Eur J Clin Pharmacol 65(9): 903-911, 2009.
18. Nguyen L, Leger F, Lennon S and Puozzo C: Intravenous busulfan in adults prior to haematopoietic stem cell transplantation: a population pharmacokinetic study. Cancer Chemoth Pharmacol 57(2): 191-198, 2006. (Pubitemid 41779838)
19. Grochow LB: Busulfan disposition: the role of therapeutic monitoring in bone marrow transplantation induction regimens. Semin Oncol 20(4 Suppl 4): 18-25, 1993.
20. Grochow LB, Jones RJ, Brundrett RB, Braine HG, Chen TL, Sarai R, Santos GW and Colvin OM: Pharmacokinetics of busulfan: Correlation with veno-occlusive disease in patients undergoing bone marrow transplantation. Cancer Chemother Pharmacol 25(1): 55-61, 1989. (Pubitemid 20000799)
21. Slattery JT, Sanders JE, Buckner CD, Schaffer RL, Lambert KW, Langer FP, Anasetti C, Bensinger WI, Fisher LD and Appelbaum FR: Graft-rejection and toxicity following bone marrow transplantation in relation to busulfan pharmacokinetics. Bone Marrow Transplant 16(1): 31-42, 1995.
22. Copelan EA, Bechtel TP, Avalos BR, Elder PJ, Ezzone SA, Scholl MD and Penza SL: Busulfan levels are influenced by prior treatment and are associated with hepatic veno-occlusive disease and early mortality but not with delayed complications following marrow transplantation. Bone Marrow Transplant 27(11): 1121-1124, 2001.
23. Dix SP, Wingard JR, Mullins RE, Jerkunica I, Davidson TG, Gilmore CE, York RC, Lin LS, Devine SM, Geller RB, Heffner LT, Hillyer CD, Holland HK, Winton EF and Saral R: Association of busulfan area under the curve with veno-occlusive disease following BMT. Bone Marrow Transplant 17(2): 225-230, 1996.
24. Ljungman P, Hassan M, Békássy AN, Ringdén O, Oberg G: High busulfan concentrations are associated with increased transplant-related mortality in allogeneic bone marrow transplant patients. 20(11): 909-913, 1997.
25. Slattery JT, Clift RA, Buckner CD, Radich J, Storer B, Bensinger WI, Soll E, Anasetti C, Bowden R, Bryant E, Chauncey T, Deeg H, Doney KC, Flowers M, Gooley T, Hansen JA, Martin PJ, McDonald GB, Nash R, Petersdorf EW, Sanders JE, Schoch G, Stewart P, Storb R, Sullivan KM, Thomas ED, Witherspoon RP and Appelbaum FR: Marrow transplantation for chronic myeloid leukemia: the influence of plasma busulfan levels on the outcome of transplantation. Blood 89(8): 3055-3060, 1997.
26. Marcus RE, Goldman JM. Convulsions due to high-dose busulphan. Lancet 2: 8417-8418, 1984.
27. Vassal G, Deroussent A, Hartmann O, Challine D, Benhamou E, Valteau-Couanet D, Brugieres L, Kalifa C, Gouyette A and Lemerle J: Dose-dependent neurotoxicity of high-dose busulfan in children: a clinical and pharmacological study. Cancer Res 50(19): 6203-6207, 1990.
28. Hassan M and Ehrsson H: Urinary metabolites of Busulfan in the rat. Drug Metab Dispos 15(3): 399-402, 1987.
29. 14C-Busulfan in isolated perfused rat liver. Eur J Drug Metab Pharmacokinet 12(1): 71-76, 1987. (Pubitemid 17120684)
30. Hassan M, Ehrsson H, Smedmyr B, Totterman T, Wallin I, Oberg G and Simonsson B: Cerebrospinal fluid and plasma concentrations of busulfan during high-dose therapy. Bone Marrow Transplant 4(1): 113-114, 1989.
31. Grigg AP, Shepherd JD and Phillips GL: Busulphan and phenytoin. Ann Intern Med 111(12): 1049-1050, 1989.
32. Canger R: (pharmacological therapy of epilepsy). Recenti Prog Med 90(7-8): 419-424, 1999.
33. Eberly AL, Anderson GD, Bubalo JS and McCune JS: Optimal prevention of seizures induced by high-dose busulfan. Pharmacotherapy 28(12): 1502-1510, 2008.
34. Anderson GD: A mechanistic approach to antiepileptic drug interactions. Ann Pharmacother 32(5): 554-563, 1998. (Pubitemid 28232761)
35. Nation RL, Evans AM and Milne RW: Pharmacokinetic drug interactions with phenytoin (Part I). Clin Pharmacokinet 18(1): 37-60, 1990. (Pubitemid 20040337)
36. (Investigator's Brochure) Intravenous Busulfan (IV Bu)-Busulfex. Pierre Fabre Médicament 2009.
37. Slattery JT and Risler LJ: Therapeutic monitoring of busulfan in hematopoietic stem cell transplantation. Ther Drug Monit 20(5): 543-549, 1998. (Pubitemid 28463447)
38. ICON Development Solutions. Ellicott City, Maryland, USA 2010.
39. National Cancer Institute Common Toxicity Criteria. (CTC v2.0, NCI 1998) 2010.
40. Andersson BS, Thall PF, Madden T, Couriel D, Wang X, Tran HT, Anderlini P, de Lima M, Gajewski J and Champlin RE: 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(9): 477-485, 2002.
41. Andersson BS, Kashyap A, Gian V, Wingard JR, Fernandez H, Cagnoni PJ, Jones RB, Tarantolo S, Hu WW, Blume KG, Forman SJ and Champlin RE: Conditioning therapy with intravenous busulfan and cyclophosphamide (i.v. BuCy2) for hematologic malignancies prior to allogeneic stem cell transplantation: a phase II study. Biol Blood Marrow Transplant 8(3): 145-154, 2002.
42. Buggia I, Zecca M, Alessandrino EP, Locatelli F, Rosti G Bosi A, Pession A, Rotoli B, Majolino I, Dallorso A, Regazzi MB: Itraconazole can increase systemic exposure to busulfan in patients given bone marrow transplantation. Anticancer Res 16(4): 2083-2088, 1996.
43. Glucksberg H, Storb R, Fefer A, Buckner CD, Neiman PE, Clift RA, Lerner KG and Thomas ED: Clinical manifestations of graft-versus-host disease in human recipients of marrow from HL-A-Matched sibling donors. Transplantation 18(4): 295-304, 1974.
44. Nevill TJ, Barnett MJ, Klingemann HG, Reece DE, Shepherd JD and Phillips GL: Regimen-related toxicity of a busulfan-cyclophosphamide conditioning regimen in 70 patients undergoing allogeneic bone marrow transplantation. Clin J Oncol 9(7): 1224-1232, 1991.
45. Ringden O, Remberger M, Ruutu T, Nikoskelainen J, Volin L, Vindelov L, Parkkali T, Lenhoff S, Sallerfors B, Mellander L, Ljungman P and Jacobsen N: Increased risk of chronic graft-versus-host Disease, obstructive bronchiolitis, and alopecia with busulfan versus total body irradiation: Long-term results of a randomized trial in allogeneic marrow recipients with Leukemia. Nordic Bone Marrow Transplantation Group. Blood 93(7): 2196-2201, 1999.
46. Marchand DH, Remmel RP, Abdel-Monem MM: Biliary excretion of a glutathione conjugate of busulfan and 1.4-diiodobutane in the rat. Drug Metab Dispos 1: 85-92, 1988.
47. Nadkarni M, Trams EG and Smith PK: Preliminary studies on the distribution and fate of TEM, TEPA, and myleran in the human. Cancer Res 19: 713-8, 1959.
48. Buckner CD*,Rudolph RH, Fefer A, Clift RA, Epstein RB, Funk DD, Neiman PE, Slichter SJ, Storb R, Thomas ED: High-dose cyclophosphamide therapy for malignant disease. Toxicity, tumor response, and the effects of stored autologous marrow. Cancer 29(2): 357-365, 1972.
49. Nation RL, Evans AM and Milne RW: Pharmacokinetic drug interactions with phenytoin (Part II). Clin Pharmacokinet 18(2): 131-50, 1990.
50. Chan KW, Mullen CA, Worth LL, Choroszy M, Koontz S, Tran H and Slopis J: Lorazepam for seizure prophylaxis during high-dose busulfan administration. Bone Marrow Transplant 29(12): 963-965, 2002.
51. Hassan M, Oberg G, Björkholm M, Wallin I and Lindgren M: Influence of prophylactic anticonvulsant therapy on high-dose busulphan kinetics. Cancer Chemother Pharmacol 33: 181-186, 1993. (Pubitemid 23361064)
52. Fitzsimmons WE, Ghalie R and Kaizer H: Anticonvulsants and busulfan. Ann Intern Med 112(7): 552-553, 1990.
53. Fitzsimmons WE, Ghalie R and Kaizer H: The effect of hepatic enzyme inducers on busulfan neurotoxicity and myelotoxicity. Cancer Chemother Pharmacol 27(3): 226-228, 1990.
54. Sandstrom M, Karlsson MO, Ljungman P, Hassan Z, Jonsson EN, Nilsson C, Ringden O, Oberg G, Bekassy A and Hassan M: Population pharmacokinetic analysis resulting in a tool for dose individualization of busulphan in bone marrow transplantation recipients. Bone Marrow Transplant 28(7): 657-664, 2001. (Pubitemid 33014599)
55. Embree L, Heggie JR, Knight G et al: Effect of phenytoin on busulfan pharmacokinetics. Pharmaceutical Res (14) 1997.
56. Carreras E, Bertz H, Arcese W, Vernant JP, Tomas JF, Hagglund H, Bandini G, Esperou H, Russell J, de la Rubia J, Di Girolamo G, Demuynck H, Hartmann O, Clausen J, Ruutu T, Leblond V, Iriondo A, Bosi A, Ben Bassat I, Koza V, Gratwohl A and Apperley JF: Incidence and outcome of hepatic veno-occlusive disease after blood or marrow transplantation: a prospective cohort study of the european group for blood and marrow transplantation. European Group for Blood and Marrow Transplantation Chronic Leukemia working party. Blood 92(10): 3599-3604, 1998.
57. Jones RJ, Lee KS, Beschorner WE, Vogel VG, Grochow LB, Braine HG, Vogelsang GB, Sensenbrenner LL, Santos GW and Sarai R: Veno-occlusive disease of the liver following bone marrow transplantation. Transplantation 44(6): 778-783, 1987. (Pubitemid 18034278)
58. Lee JH, Lee KH, Lee JH, Kim S, Seol M, Park CJ, Chi HS, Kang W, Kim ST, Kim WK and Lee JS: Plasminogen activator inhibitor-1 is an independent diagnostic marker as well as severity predictor of hepatic veno-occlusive disease after allogeneic bone marrow transplantation in adults conditioned with busulphan and cyclophosphamide. Br J Haematol 118(4): 1087-1094, 2002. (Pubitemid 35025974)
59. Shulman HM and Hinterberger W: Hepatic veno-occlusive disease-liver toxicity syndrome after bone marrow transplantation. Bone Marrow Transplant 10(3): 197-214, 1992.
60. Bearman SI: Avoiding hepatic veno-occlusive disease: What do we know and where are we going? Bone Marrow Transplant 27(11): 1113-1120, 2001.
61. Bearman SI: The syndrome of hepatic veno-occlusive disease after marrow transplantation. Blood 85(11): 3005-3020, 1995.
62. Bearman SI, Anderson GL, Mori M, Hinds MS, Shulman HM and McDonald GB: Venoocclusive disease of the liver: Development of a model for predicting fatal outcome after marrow transplantation. Clin J Oncol 11(9): 1729-1736, 1993. (Pubitemid 23277325)
63. Bearman SI, Appelbaum FR, Buckner CD, Petersen FB, Fisher LD, Clift RA and Thomas ED: Regimen-related toxicity in patients undergoing bone marrow transplantation. Clin J Oncol 6(10): 1562-1568, 1988. (Pubitemid 19092391)
64. McDonald GB, Hinds MS, Fisher LD, Schoch HG, Wolford JL, Banaji M, Hardin BJ, Shulman HM and Clift RA: Venoocclusive disease of the liver and multiorgan failure after bone marrow transplantation: a cohort study of 355 patients. Ann Intern Med 118(4): 255-267, 1993. (Pubitemid 23046384)