A Controlled Trial of Mitoxantrone in Multiple Sclerosis: Serial MRI Evaluation at One Year

Bastianello, Stefano; Pozzilli, Carlo; D'Andrea, F; Millefiorini, Enrico; Trojano, María; Morino, Stefania; Gasperini, Claudio; Bozzao, Alessandro; Gallucci, M.; Andreula, C.F.; Bozzao, L.; Gambi, D.; Prencipe, Massimiliano

doi:10.1017/s0317167100041263

Cited by 49 publications

(14 citation statements)

References 23 publications

(16 reference statements)

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…In fact, benefit can be seen in disease progression in patients with secondary progressive MS (SPMS) 1 3 -1 5 . Randomized studies has also showed reduction of relapsing and new lesions incidence using magnetic resonance imaging (MRI) [16][17][18] . Mitoxantrone (MX) acts as an immunosupressive agent which alters B and T lymphocytes responses to central nervous system (CNS) antigens, and through this process it seems to avoid axonal lesion and macrophages mediated demyelination [1][2][3][4][5][6][7][8][9]13,19 .…”

Section: Mitoxantrone Hydrochloride (Novantronementioning

confidence: 99%

Mitoxantrone in secondarily progressive multiple sclerosis: a series of 18 patients

Montú

Arruda

Oliveira

et al. 2005

Arq. Neuro-Psiquiatr.

View full text Add to dashboard Cite

Mitoxantrone hydrochloride (Novantrone®) is an anthracenedione that has been used as one of the latest in a long line of general immunosuppresive agents studied in multiple sclerosis (MS). We reviewed the clinical, laboratory, neuroimaging and echocardiography data of 18 patients from February 2001 to March 2004 out of a total number of 100 patients with definite MS. Fourteen patients were women (77.7%) and four were men. The mean age of the patients was 41.6±10 years old (confidence intervals 95%: 36.4-46.7 years old). The mean duration of disease was 10.5±6.3 years. Fourteen patients had the secondarily progressive form of MS, and four had the relapsing-remitting form. Mitoxantrone is an useful and clinically effective drug in MS and its major limitation is the potencial cardiotoxicity due to cumulative dose (140 mg).

show abstract

Section: Mitoxantrone Hydrochloride (Novantronementioning

confidence: 99%

Mitoxantrone in secondarily progressive multiple sclerosis: a series of 18 patients

Montú

Arruda

Oliveira

et al. 2005

Arq. Neuro-Psiquiatr.

View full text Add to dashboard Cite

show abstract

“…In addition, in a subgroup of patients (13 MTX and 12 placebo) a serial enhanced MRI study was performed at 0, 2, 4, 6 and 12 months from the beginning of the study [1].…”

Section: Safety Evaluationmentioning

confidence: 99%

Randomized placebo-controlled trial of mitoxantrone in relapsing-remitting multiple sclerosis: 24-month clinical and MRI outcome

Millefiorini

Gasperini

Pozzilli

et al. 1997

Journal of Neurology

Self Cite

256

144

View full text Add to dashboard Cite

We designed a randomized, placebo-controlled, multicentre trial involving 51 relapsing-remitting multiple sclerosis patients to determine the clinical efficacy of mitoxantrone treatment over 2 years. Patients were allocated either to the mitoxantrone group (27 patients receiving I.V. infusion of mitoxantrone every month for 1 year at the dosage of 8 mg/m2) or to the placebo group (24 patients, receiving I.V. infusion of saline every month for 1 year) using a centralized randomization system. Disability at entry and at 12-24 months was evaluated by four blinded neurologists trained in the application of the Kurtzke Expanded Disability Scale (EDSS). In addition, the number and clinical characteristics of the exacerbations over the 24 months were recorded by the local investigators. MRI, at 0, 12 and 24 months, was performed with a 0.2 T permanent unit. MRI data were analysed by two blinded neuroradiologists. All patients underwent a clinical evaluation. A statistically significant difference in the mean number of exacerbations was observed between the mitoxantrone group and placebo group both during the 1st and the 2nd year. Although there was no statistically significant benefit in terms of mean EDSS progression over 2 years, the proportion of patients with confirmed progression of the disease, as measured by a one point increase on the EDSS scale, was significantly reduced at the 2nd year evaluation in the mitoxantrone group. Forty-two (23 mitoxantrone, 19 placebo) patients underwent all MRI examinations during the 24-month period. We observed a trend towards a reduction in the number of new lesions on T2-weighted images in the mitoxantrone group. Our study suggests that mitoxantrone might be effective in reducing disease activity, both by decreasing the mean number of exacerbations and by slowing the clinical progression sustained by most patients after 1 year from the end of treatment.

show abstract

“…22 All patients had RRMS with at least two attacks in the 2 years preceding study entry. The mean EDSS score was 3.7 in the treated group and 3.5 in the placebo group.…”

mentioning

confidence: 99%

The use of mitoxantrone (Novantrone) for the treatment of multiple sclerosis [RETIRED]

et al. 2003

View full text Add to dashboard Cite

Abstract-Mitoxantrone is the first drug approved for the treatment of secondary progressive multiple sclerosis (SPMS) in the United States. This assessment considers use of mitoxantrone in the treatment of MS. Mitoxantrone probably reduces the clinical attack rate and reduces attack-related MRI outcomes in patients with relapsing MS (Type B recommendation). Also, mitoxantrone may have a beneficial effect on disease progression in patients with MS whose clinical condition is worsening (Type B recommendation). The potential for serious toxicity of mitoxantrone, however, must be taken into account when considering this therapy in individual patients. Moreover, because the potential clinical benefits on disease progression appear to be only modest, the results of the single phase III trial should be replicated in another (and hopefully much larger) clinical study before this agent is widely recommended for the treatment of patients with MS. NEUROLOGY 2003;61:1332-1338 Mitoxantrone hydrochloride (Novantrone) is an anthracenedione that has been used as an antineoplastic agent to treat hormone-refractory prostate cancer and acute nonlymphocytic leukemia in adults. It exerts its antineoplastic action by intercalating into DNA and producing both DNA strand-breaks and interstrand cross-links; it also interferes with RNA synthesis and markedly inhibits the enzyme topoisomerase II, which aids in the DNA repair process. [1][2][3][4] In the treatment of MS, mitoxantrone represents the latest in a long line of general immunosuppressive agents studied in this disease. Previously, most such agents have not shown clear-cut benefits in this condition. [5][6][7][8][9][10] On the basis of a phase III clinical trial in Europe, 11,12 and an earlier phase II study, 13 mitoxantrone recently received an expanded indication from the Food and Drug Administration (FDA) for use in secondary progressive MS (SPMS), in progressiverelapsing MS, and for patients with worsening relapsing-remitting (RR) MS. This last category is defined as patients whose neurologic status remains significantly abnormal between MS attacks.Mitoxantrone is the first drug approved for these indications in the United States, and it is the purpose of this assessment to consider both the evidence leading to the recent FDA approval as well as the appropriate clinical role of this agent in the management of patients with MS.Description of the analytic process. Articles for this review were searched in Medline under the keywords mitoxantrone and MS. Forty-one articles were identified by this search. The abstracts of these articles were reviewed and the original articles were selected for inclusion in the analysis only if they were either controlled trials or case series using mitoxantrone in the treatment of MS. Five such articles were identified, in addition to the phase III trial. 11,12 In addition, the reference lists of the articles found in this manner were also reviewed to identify articles or abstracts not found by the computer search.Analysis of the evidence. Followi...

show abstract

A Controlled Trial of Mitoxantrone in Multiple Sclerosis: Serial MRI Evaluation at One Year

Cited by 49 publications

References 23 publications

Mitoxantrone in secondarily progressive multiple sclerosis: a series of 18 patients

Mitoxantrone in secondarily progressive multiple sclerosis: a series of 18 patients

Randomized placebo-controlled trial of mitoxantrone in relapsing-remitting multiple sclerosis: 24-month clinical and MRI outcome

The use of mitoxantrone (Novantrone) for the treatment of multiple sclerosis [RETIRED]

Contact Info

Product

Resources

About