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An open-trial evaluation of mitoxantrone in the treatment of progressive MS

Department of Clinical Neurological Sciences (Drs. Noseworthy, Karlik, Lee, Rice, and Ebers, and M.B. Hopkins, M.K. Vandervoort, and M. Penman) and the Department of Radiology (Drs. Karlik and Lee), University of Western Ontario, London; and the Clinical Research Division (Drs. Grinwich and Harris, and H. Cauvier), Cyanamid, Canada, Inc., Toronto, ON, Canada.

We treated 13 patients with progressive MS with mitoxantrone. All patients received a standard IV dose of mitoxantrone (8 mg/m²) every 3 weeks for a total of seven infusions, with dosage adjustments depending on the hematologic profile at the nadir. The treatment was well tolerated, with the most common side effect being mild nausea. Four of seven women developed transient secondary amenorrhea. The postenrollment clinical behavior of these patients was generally more favorable than during the 18 months prior to enrollment (only three of 13 patients developed an increase in the Expanded Disability Status Scale of more than 0.5 points), suggesting a possible treatment effect, but comparison with two historical control groups (both the active and placebo groups from the Canadian Cooperative Trial of Cyclophosphamide and Plasma Exchange) does not suggest that mitoxantrone was efficacious. Eight of 12 patients had evidence of MRI activity on 13 of 29 follow-up visits. This small, open-labeled pilot study did not provide strong support for proceeding with a randomized, controlled trial of this dosage regimen of mitoxantrone in patients with progressive MS.

Presented in part at the 43rd annual meeting of the American Academy of Neurology, Boston, MA, April 1991.

Address correspondence and reprint requests to Dr. J.H. Noseworthy, Mayo Clinic/Foundation, Department of Neurology, 200 First Street, SW, Rochester, MN 55905.

Supported by a grant from Cyanamid International Clinical Research. J.H.N, is the recipient of a Career Development Award from the Multiple Sclerosis Society of Canada. G.P.A.R. is supported by a Career Scientist Award from the Ontario Ministry of Health.

Received June 5,1992. Accepted for publication in final form November 13,1992.

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