Long-term safety profile of mitoxantrone in a French cohort of 802 multiple sclerosis patients: A 5-year prospective study

Multiple Sclerosis Journal

Volumn 17, Issue 7, 2011, Pages 867-875

  Le Page, E ^a,b,c   Leray, E ^a,b   Edan, G ^a,b  

^a PONTCHAILLOU UNIVERSITY HOSPITAL   (France)

^b UNIVERSITÉ DE RENNES 1   (France)

^c RENNES UNIVERSITY HOSPITAL   (France)

Author keywords

disease modifying therapies; mitoxantrone; multiple sclerosis; tolerance

Indexed keywords

MITOXANTRONE;

ADULT; AMENORRHEA; ARTICLE; CONGESTIVE HEART FAILURE; DRUG SAFETY; ECHOCARDIOGRAPHY; FEMALE; FOLLOW UP; FRANCE; HEART LEFT VENTRICLE EJECTION FRACTION; HUMAN; LONG TERM CARE; MAJOR CLINICAL STUDY; MULTIPLE SCLEROSIS; PROSPECTIVE STUDY; TREATMENT DURATION;

EID: 79959520067     PISSN: 13524585     EISSN: 14770970     Source Type: Journal    
DOI: 10.1177/1352458511398371     Document Type: Article

References (36)

1. Vollmer T, Stewart T, Baxter N. Mitoxantrone and cytotoxic drugs' mechanisms of action. Neurology. 2010 ; 74: 41-46
2. Edan G, Miller D, Clanet M, et al. Therapeutic effect of mitoxantrone combined with methylprednisolone in multiple sclerosis: a randomised multicenter study of active disease using MRI and clinical criteria. J Neurol Neurosurg Psychiatry. 1997 ; 62: 112-118 (Pubitemid 27090928)
3. Hartung HP, Gonsette R, Konig N, et al. Mitoxantrone in progressive multiple sclerosis: a placebo-controlled, double-blind, randomised, multicentre trial. Lancet. 2002 ; 360: 2018-2025 (Pubitemid 36026580)
4. Wilson EB. Probable inference, the law of succession, and statistical inference. J Am Stat Assoc. 1927 ; 22: 209-212
5. Feuillet L, Guedj E, Eusebio A, et al. Acute heart failure in a patient treated by mitoxantrone for multiple sclerosis. Rev Neurol. 2003 ; 159: 1169-1172 (Pubitemid 38133563)
6. Brassat D, Recher C, Waubant E, et al. Therapy-related acute myeloblastic leukemia after mitoxantrone treatment in a patient with MS. Neurology. 2002 ; 59: 954-955
7. Ghalie RG, Mauch E, Edan G, et al. A study of therapy-related acute leukaemia after mitoxantrone therapy for multiple sclerosis. Mult Scler. 2002 ; 8: 441-445
8. Capobianco M, Malucchi S, Ulisciani S, et al. Acute myeloid leukemia induced by mitoxantrone treatment for aggressive multiple sclerosis. Neurol Sci. 2008 ; 29: 185-187 (Pubitemid 352003657)
9. Ramkumar B, Chadha MK, Barcos M, Sait SN, Heyman MR, Baer MR. Acute promyelocytic leukemia after mitoxantrone therapy for multiple sclerosis. Cancer Genet Cytogenet. 2008 ; 182: 126-129 (Pubitemid 351491326)
10. Sumrall A, Dreiling B. Therapy-related acute nonlymphoblastic leukemia following mitoxantrone therapy in a patient with multiple sclerosis. J Miss State Med Assoc. 2007 ; 48: 206-207
11. Cartwright MS, Jeffery DR, Lewis ZT, et al. Mitoxantrone for multiple sclerosis causing acute lymphoblastic leukaemia. Neurology. 2007 ; 68: 1630-1631 (Pubitemid 46717990)
12. Ledda A, Caocci G, Spinicci G, Cocco E, Mamusa E, La Nasa G. Two new cases of acute promyelocytic leukemia following mitoxantrone treatment in patients with multiple sclerosis. Leukemia. 2006 ; 20: 2217-2218 (Pubitemid 44782862)
13. Nollet S, Berger E, Deconinck E, Baldauf E, Rumbach L. Acute leukaemia in two multiple sclerosis patients treated with mitoxantrone. Rev Neurol (Paris). 2006 ; 162: 157-159
14. Arruda WO, Montú MB, de Oliveira Mde S, Ramina R. Acute myeloid leukaemia induced by mitoxantrone: case report. Arq Neuropsiquiatr. 2005 ; 63: 327-329 (Pubitemid 40834733)
15. Voltz R, Starck M, Zingler V, Strupp M and Kolb HJ. Mitoxantrone therapy in multiple sclerosis and acute leukaemia: a case report out of 644 treated patients. Mult Scler 2004; 10: 472-474. (Pubitemid 39117348)
16. Tanasescu R, Debouverie M, Pittion S, Anxionnat R, Vespignani H. Acute myeloid leukaemia induced by mitoxantrone in a multiple sclerosis patient. J Neurol. 2004 ; 251: 762-763 (Pubitemid 38824028)
17. Novoselac AV, Reddy S, Sanmugarajah J. Acute promyelocytic leukemia in a patient with multiple sclerosis following treatment with mitoxantrone. Leukemia. 2004 ; 18: 1561-1562 (Pubitemid 39264087)
18. Delisse B, de Seze J, Mackowiak A, et al. Therapy related acute myeloblastic leukaemia after mitoxantrone treatment in a patient with multiple sclerosis. Mult Scler. 2004 ; 10: 92-92
19. Cattaneo C, Almici C, Borlenghi E, Motta M and Rossi G. A case of acute promyelocytic leukaemia following mitoxantrone treatment of multiple sclerosis. Leukemia 2003; 17: 985-986. (Pubitemid 36626331)
20. Heesen C, Bruegmann M, Gbdamosi J, Koch E, Mönch A, Buhmann C. Therapy-related acute myelogenous leukaemia (t-AML) in a patient with multiple sclerosis treated with mitoxantrone. Mult Scler. 2003 ; 9: 213-214 (Pubitemid 36426997)
21. Jaster JH, Niell HB, Dohan FC, Smith TW. Therapy-related acute myeloblastic leukemia after mitoxantrone treatment in a patient with MS. Neurology. 60: 1399-1400
22. Vicari AM, Ciceri F, Folli F, et al. Acute promyelocytic leukemia following mitoxantrone as single agent for the treatment of multiple sclerosis. Leukemia. 1998 ; 12: 441-442 (Pubitemid 28138231)
23. Pielen A, Goffette S, Van Pesch V, Gille M, Sindic CJ. Mitoxantrone-related acute leukemia in two MS patients. Acta Neurol Belg. 2008 ; 108: 99-102
24. Bosca I, Pascual AM, Casanova B, Coret F, Sanz MA. Four new cases of therapy-related acute promyelocytic leukemia after mitoxantrone. Neurology. 2008 ; 71: 457-458
25. Ellis R, Boggild M. Therapy-related acute leukaemia with mitoxantrone: what is the risk and can we minimise it?. Mult Scler. 2009 ; 15: 505-508
26. Marriott JJ, Miyasaki JM, Gronseth G, O'Connor PW. Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Evidence Report: The efficacy and safety of mitoxantrone (Novantrone) in the treatment of multiple sclerosis: Report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology. 2010 ; 74: 1463-1470
27. Martinelli V, Bergamaschti R, Bellantonio P, et al. Incidence rate of acute myeloid leukemia and related mortality in Italian MS patients treated with mitoxantrone. Mult Scler. 2010 ; 16: S160 - S160
28. Rivera V, Weinstock-Guttman B, Beagan J, Al-Sabbagh A, Bennett R, Dangond F. Final results from Registry to Evaluate Novantrone Effects in Worsening Multiple sclerosis study (RENEW). Mult Scler. 2009 ; 15: S254 - S254
29. Knight JA, Skol AD, Shinde A, et al. Genome-wide association study to identify novel loci associated with therapy-related myeloid leukemia susceptibility. Blood. 2009 ; 113: 5575-5582
30. Ghalie RG, Edan G, Laurent M, et al. Cardiac adverse effects associated with mitoxantrone (Novantrone) therapy in patients with MS. Neurology. 2002 ; 59: 909-913
31. Gofette S, Van Pesch V, Vanoverschelde JL, Morandini E, Syndic C. Severe delayed heart failure in three multiple sclerosis previously treated with mitoxantrone. J. Neurol. 2005 ; 252: 1217-1222 (Pubitemid 41443622)
32. A survey on the quality of care among patients with heart failure in Europe. Eur. Heart J. 2003 ; 24: 422-474
33. Kingwell E, Koch M, Leung B, et al. Cardiotoxicity and other adverseevents associated with mitoxantrone treatment for MS. Neurology 2010; 74: 1822-1826.
34. Blumenfeld Z, Dann E, Avivi I, Epelbaum R, Rowe JM. Fertility after treatment for Hodgkin's disease. Ann Oncol. 2002 ; 13: 138-1347
35. Walshe JM, Denduluri N, Swain SM. Amenorrhea in premenopausal woman after adjuvant chemotherapy for breast cancer. J Clin Oncol. 2006 ; 24: 5769-5779 (Pubitemid 46646480)
36. Cocco E, Sardu C, Gallo P, et al. Frequency and risk factors of mitoxantrone-induced amenorrhea in multiple sclerosis: the FEMIMS study. Mult Scler. 2008 ; 14: 1225-1233