Therapy-related acute leukaemia with mitoxantrone: Four years on,what is the risk and can it be limited?

Abstract

Therapy-related acute leukaemia (TRAL) is a significant concern, when considering treatment with mitoxantrone for multiple sclerosis (MS). We re-evaluated the literature, identifying all case reports and series of > 50 patients reporting TRAL cases in MS. TRAL was diagnosed in 0.73% of the 12,896 patients identified. Median onset was 22 months following treatment. We calculated a number needed to harm of 137.5 exposed patients, significantly higher than our 2008 analysis. We found that 82.8% of patients were exposed to > 60 mg/m² with a relative risk of 1.85 (p = 0.018) compared to < 60mg/m², strongly suggesting a relationship to dose. MS treatment regimens which limit the mitoxantrone dose to < 60mg/m² reduce the risk of TRAL.

Keywords

Adverse effects disease-modifying therapies dosage leukemia mitoxantrone multiple sclerosis relapsing-remitting multiple sclerosis therapy-related acute leukemia

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