
Induction Therapy with Mitoxantrone Reduces
Relapses in Multiple Sclerosis
DENVER, CO -- April 17, 2002 -- Used in
induction therapy, mitoxantrone dramatically decreases disease activity in
multiple sclerosis (MS) patients for at least four years, according to a study
presented at the Annual Meeting of the American Academy of Neurology (AAN) in
Denver, Colorado.
Mitoxantrone is a chemical routinely used to
fight breast cancer, leukemia and malignant lymphoma.
Frequently used against cancers, induction
therapy is designed to wipe out abnormal cells and allow for the re-growth of
normal cells.
Mitoxantrone for the treatment of MS has
recently been approved by the U.S. Food and Drug Administration. It has been
used to treat MS in France for more than a decade. Researchers from CHU
Pontchaillou of Rennes, France, have demonstrated that mitoxantrone induction
therapy for relapsing-remitting MS (RRMS) patients has produced dramatic results
in disease activity.
Over the past ten years, 100 worsening RRMS
patients were given initial mitoxantrone induction therapy for six months, with
mitoxantrone combined with methylprednisolone administered intravenously on a
monthly schedule. The annual relapse rate decreased significantly from 3.20
during the 12 months preceding mitoxantrone onset to 0.30 during the first year
following induction onset, corresponding to a reduction of nearly 90 percent
that was maintained for more than five years. The percentage of relapse-free
patients was 76 percent at one year of follow-up, and was maintained at 64
percent, 45 percent, and 43 percent at years two, three and four, respectively,
with a median time to the first relapse of 2.8 years.
"The clinical benefit and reduction of
disease activity supports our belief that mitoxantrone, as administered in this
study, may be an effective induction treatment before initiating other long-term
disease modifying therapies for worsening relapsing-remitting MS patients,"
commented study author Emmanuelle Le Page, MD.
SOURCE: American Academy of Neurology
| Neurology 2002 Sep 24;59(6):954-5 |
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Therapy-related acute myeloblastic leukemia after
mitoxantrone treatment in a patient with MS.
Brassat D, Recher C, Waubant E, Le Page E, Rigal-Huguet F, Laurent G, Edan G,
Clanet M.
Departments of Neurology (Drs. Brassat and Clanet) and Haematology (Drs. Recher,
Rigal-Huguet and Laurent) Hopital Purpan, Toulouse University Medical Center,
Toulouse.
The authors report a patient with severe secondary progressive MS who responded
to mitoxantrone but developed a fatal acute myeloblastic leukemia 15 months
after completion of mitoxantrone therapy. Therapy-related acute leukemia (TRAL)
in relation with mitoxantrone is rare; this patient was the first case among a
cohort of 802 French MS patients treated with mitoxantrone. Nevertheless, this
case stresses the need to further evaluate the long-term risk of TRAL in
patients with MS who receive mitoxantrone.
PMID: 12297591 [PubMed - in process]
A study of therapy-related acute leukaemia after
mitoxantrone therapy for multiple sclerosis
Multiple
Sclerosis,
1 October
2002, vol. 8, no. 5, pp. 441-445(5)
Ghalie R.[1]; Mauch E.[2]; Edan G.[3]; Hartung H.[4]; Gonsette R.[5];
Eisenmann S.[2]; Le Page E.[3]; Butine M.[1]; Goodkin D.[1]
[1] Immunex Corporation, 51 University Street, Seattle, Washington
98101, USA [2] The Clinic for Neurological Diseases, Ditenbroon 7,
Schwendi D-88477, Germany [3] Clinique Neurologique, Hôpital
Pontchaillou, Rennes 35033, France [4] Neurologische Klinik-Universität
Graz, Auenbruggerplatz 22, Graz A-8036, Austria [5] Centre National de
la Sclerose en Plaques, Van Heylenstraat 16, Melsbroek B-1820, Belgium
Abstract:
To evaluate the incidence of therapy-related acute leukaemia
(t-AL) after single-agent mitoxantrone (MITO) treatment, we reviewed
medical records of patients in three studies of single-agent MITO
therapy for multiple sclerosis (MS) and existing literature on MITO
therapy in MS, leukaemia, and solid tumors. Of 1378 MITO recipients in
the three MS studies (mean cumulative dose of 60 mg/m2 and
mean follow-up of 36 months), one patient had t-AL, an observed
incidence proportion of 0.07% [95% confidence interval (CI)=0.00 -
0.40%]. There were no cases of t-AL in published reports of nine
additional studies of single-agent MITO therapy for MS. There was one
published case report of acute promyelocytic leukaemia detected five
years after initiating MITO therapy for MS. The observed incidence
proportion of t-AL is very low in patients who received MITO as
single-agent therapy for MS. Although these observations provide
preliminary reassurance, extended follow-up of these patients and those
who receive higher cumulative doses of MITO is required to define the
long-term risk of t-AL after MITO therapy for MS.
Keywords: LEUKAEMIA; MITOXANTRONE; MULTIPLE
SCLEROSIS; MYELODYSPLASTIC SYNDROME
Document Type: Research article
ISSN: 1352-4585
| SICI (online): |
1352-4585(20021001)8:5L.441;1- |
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