Reactions 798 - 22 Apr 2000

Severe neuropsychiatric toxicitywith interferon-α-2b + cytarabinePatients who receive interferon-α-2b plus low-dose

cytarabine for the treatment of chronic myelogenousleukaemia are at increased risk of developing severeneuropsychiatric toxicity, particularly if they have apretreatment history of neurological or psychiatricdisorders. These are the main findings of a studyconducted by US researchers.

The researchers used data for 91 patients (median age48 years) who participated in a Cancer and LeukemiaGroup B (CALGB) study. Patients received SC interferon-α-2b 5 MU/m2/day plus SC cytarabine 10–15 mg/m2

twice daily. The dosages were adjusted according topatients’ WBC counts.

The study showed that 22 patients (24%) developedgrade 3 or 4 neuropsychiatric toxicity that affected dailyfunctioning. Symptoms included disorientation,confusion, suicidal ideation, ataxia, vertigo, slurredspeech, mood swings and inability to sleep. Theseevents resolved after treatment withdrawal in allpatients. Six of these patients were rechallenged withinterferon-α-2b plus cytarabine, and 5 of these patientsdeveloped recurrence or worsening of these symptoms.Neuropsychiatric toxicity occurred significantly morefrequently in patients with a pretreatment history ofneurological or psychiatric diagnosis (12 of 19 patients;63%) than among those without such history (10 of 72;14%): risk ratio 4.55 (95% CI 2.33–2.88).Hensley ML, et al. Risk factors for severe neuropsychiatric toxicity in patientsreceiving interferon alfa-2b and low-dose cytarabine for chronic myelogenousleukemia: analysis of Cancer and Leukemia group B 9013. Journal of ClinicalOncology 18: 1301-1308, Mar 2000 800823412

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Reactions 22 Apr 2000 No. 7980114-9954/10/0798-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved