Abstract Details

Title Cancer Incidence in 677 Mitoxantrone-Treated People with Multiple Sclerosis: A Retrospective German Single Center Cohort Study

Topic MS and Related Diseases

Presentation(s) P01 - (-)

Poster/Presentation
Number 175

Objective

Background BACKGROUND: Immunosuppressive treatment of MS patients with mitoxantrone carries a now well-established risk of acute myeloid leukemia. To date, only few studies investigated the risk of other cancer types.

Design/Methods DESIGN/METHODS: Our study protocol was approved by the Local Ethics Committee. Using hospital records, we identified and characterized all MS patients, who presented from 1994 to 2010 and had received at least one dose of mitoxantrone at our department until then. Subsequently, we searched the regional cancer registry and tried to locate and contact all mitoxantrone patients and their physicians.

Results RESULTS: Complete active follow-up information regarding life status, cause of death and cancer diagnoses was obtained in all but one out of 677 mitoxantrone-treated MS patients (67% female). Mean EDSS at mitoxantrone initiation was 5.0 (SD 1.6). Mean follow-up time was 118 months (SD 102, range 11-265), corresponding to 6220 person years. Mean cumulative mitoxantrone exposure was 77.4 mg/m[sup2] (SD 34.3, range 9-186). Excluding skin cancers except melanoma, we identified 37 patients (5.4%) with medically confirmed malignant cancer diagnosed after mitoxantrone initiation, corresponding to a standardized incidence ratio of 1.54 (95% confidence interval: 1.09-2.12) compared to the sex-, age- and calendar year-matched German general population. Tumor entities included breast cancer (n=9), colorectal cancer (n=7), acute myeloid leukemia (n=4, 0.6%), glioblastoma multiforme, lung, pancreatic and prostate cancer (each n=2), and others (each n=1). Fifty-five patients (8.1%) had died, 10 of them from malignant cancer, 45 reportedly from other causes. Analyses of cancer entities and confounding factors will be presented.

Conclusions CONCLUSIONS: This data set indicates an acceptably low carcinogenic potential of mitoxantrone in MS patients at medium-term, which may help to inform treatment decisions.

Authors/Disclosures
Mathias Buttmann, MD (Caritas Hospital) PRESENTER	Dr. Buttmann has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. Dr. Buttmann has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Buttmann has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi. Dr. Buttmann has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Celgene. Dr. Buttmann has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Das Fortbildungskolleg. Dr. Buttmann has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Roche. Dr. Buttmann has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Novartis. Dr. Buttmann has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Teva. Dr. Buttmann has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Schmitz Kommunikation GmbH. Dr. Buttmann has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Coloplast.
	No disclosure on file
	No disclosure on file
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Klaus V. Toyka, MD, FRCP, FAAN (Neurologische Klinik Der Universitat)	No disclosure on file

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