Abstract | BACKGROUND: From 2001, a French multicentre study was conducted prospectively in a large cohort of MS patients and annually updated up to at least 5 years after initiation of MITOX therapy. OBJECTIVE: METHODS: Eight hundred and two patients from 12 MS centres (308 relapsing-remitting, 352 secondary progressive and 142 primary progressive) received MITOX monthly for 6 months (87%) or every 3 months (13%). Patients underwent clinical and haematologic evaluations before every MITOX infusion and every 6-12 months up to 5 years after MITOX start. Echocardiograms were performed at the start and end of MITOX and up to 5 years after. RESULTS: The cohort was followed for 5354 patient-years (mean). One out of 802 patients (0.1%) presented with acute congestive heart failure and 39 out of 794 patients (4.9%) presented with asymptomatic left ventricular ejection fraction reduction under 50% (persistent in 11 patients (28%), transient in 27 patients (69%), on the last scan at year 5 in 1 patient). Two cases of therapy-related leukaemia (0.25%) were detected 20 months after MITOX start (one death and one with 8 years confirmed remission). Of the 317 women treated before the age of 45, 17.3% developed a persistent age-dependant amenorrhea. CONCLUSION: This large cohort with at least 5 years of follow-up provided good insights into the long-term safety profile of MITOX in MS.
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Authors | E Le Page, E Leray, G Edan, French Mitoxantrone Safety Group |
Journal | Multiple sclerosis (Houndmills, Basingstoke, England)
(Mult Scler)
Vol. 17
Issue 7
Pg. 867-75
(Jul 2011)
ISSN: 1477-0970 [Electronic] England |
PMID | 21325016
(Publication Type: Journal Article, Multicenter Study)
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Chemical References |
- Immunologic Factors
- Mitoxantrone
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Topics |
- Adult
- Amenorrhea
(chemically induced)
- Female
- France
- Heart Failure
(chemically induced, physiopathology)
- Humans
- Immunologic Factors
(administration & dosage, adverse effects)
- Leukemia
(chemically induced)
- Male
- Middle Aged
- Mitoxantrone
(administration & dosage, adverse effects)
- Multiple Sclerosis, Chronic Progressive
(diagnosis, drug therapy)
- Multiple Sclerosis, Relapsing-Remitting
(diagnosis, drug therapy)
- Prospective Studies
- Risk Assessment
- Risk Factors
- Stroke Volume
(drug effects)
- Time Factors
- Treatment Outcome
- Ventricular Dysfunction, Left
(chemically induced, physiopathology)
- Ventricular Function, Left
(drug effects)
- Young Adult
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