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Safety and tolerability of cyclophosphamide ‘pulses’ in multiple sclerosis: a prospective study in a clinical cohort

Department of Neurology, University of Florence, Florence, Italy

V Zipoli

Department of Neurology, University of Florence, Florence, Italy

G Siracusa

Department of Neurology, University of Florence, Florence, Italy

S Piacentini

Department of Neurology, University of Florence, Florence, Italy

S Sorbi

Department of Neurology, University of Florence, Florence, Italy

M P Amato

Department of Neurology, University of Florence, Florence, Italy, mariapia.amato{at}unifi.it

To assess the safety and tolerability of cyclophosphamide (C TX) ‘pulse’ therapy in progressive or very active multiple sclerosis (MS), we reviewed our experience in a cohort of MS patients who have been treated and prospectively followed-up in our Department since 1997. O ne hundred and twelve patients received intravenous C TX in monthly ‘pulses’ for 12 months at the dosage of 700 mg/m² of body surface, then bimonthly for another 12 months. We evaluated the frequency and the severity of side-effects, as well as overall tolerability by the patient perspective using a visual analogue scale (VAS). Side-effects resulted in the discontinuation of therapy in 20 (18%) cases. Serious side-effects were observed in 24 patients (21.4%), most commonly definitive amenorrhea (33.3% of fertile women), hypogammaglobulinemia (5.4%), and hemorrhagic cystitis (4.5%). Malignancies were diagnosed in four (3.6%) subjects, three of whom were previously treated with azathioprine (AZA). Finally, 81.8% of the patients judged the treatment regimen as very or relatively acceptable and tolerable. O ur data point to a reasonable safety and tolerability of C TX ‘pulse’ therapy. Further trials are needed to definitively assess the efficacy of C TX as an alternative therapeutic option for progressive or very active MS.

Key Words: cyclophosphamide • multiple sclerosis • pulse • safety • therapy • tolerability

Multiple Sclerosis, Vol. 9, No. 5, 446-450 (2003)
DOI: 10.1191/1352458503ms926oa


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