Cancer incidence in a trial of an antiapoptotic agent for Parkinson's disease

We performed a placebo‐controlled trial of CEP‐1347, an inhibitor of neuronal apoptotic cell death, in patients with early Parkinson's disease (PD) to determine whether long‐term therapy would slow disability progression. This also provided an opportunity to monitor cancer incidence in a large...

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Bibliographic Details
Published in:Movement disorders 2010-09, Vol.25 (12), p.1801-1808
Main Authors: Schwid, Steven R., Bausch, Janice, Oakes, David, Schuchter, Lynn, Tanner, Caroline, Forrest, Misser, Lang, Anthony E., Shoulson, Ira
Format: Article
Language:English
Subjects:
Aged
apoptosis
Biological and medical sciences
cancer
Carbazoles - adverse effects
Carbazoles - therapeutic use
Chi-Square Distribution
Comorbidity
Degenerative and inherited degenerative diseases of the nervous system. Leukodystrophies. Prion diseases
Disease Progression
Double-Blind Method
Follow-Up Studies
Humans
Incidence
L-dopa
Longitudinal Studies
Medical sciences
Melanoma
Middle Aged
Neoplasms - epidemiology
Neoplasms - etiology
Neurology
Parkinson Disease - drug therapy
Parkinson Disease - epidemiology
Parkinson's disease
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Summary:We performed a placebo‐controlled trial of CEP‐1347, an inhibitor of neuronal apoptotic cell death, in patients with early Parkinson's disease (PD) to determine whether long‐term therapy would slow disability progression. This also provided an opportunity to monitor cancer incidence in a large cohort of PD patients followed prospectively including periods before and after patients developed disability requiring dopaminergic therapy. This was a multicenter study of 806 patients with early PD, without disability requiring dopaminergic therapy, assigned randomly to placebo or one of three doses of CEP‐1347. Patients were monitored for an average of 1.8 years (1,467 patient‐years) with routine cancer screening evaluations and annual skin examinations by a dermatologist. There was no significant excess of cancers among patients taking CEP‐1347 compared with placebo for any cancer type (all P > 0.1). Nonmelanoma skin cancers were the most common cancer type observed. The incidence of melanomas was 20.9 times that predicted in the general population. Most melanomas occurred in patients who had never taken dopaminergic therapy. We found no evidence that CEP‐1347 affected cancer incidence within 2 years of follow‐up. Melanoma occurrence in our PD patients was greater than predicted compared with the general population and was unrelated to dopaminergic therapy. Clinical surveillance of PD patients for melanoma may be warranted. © 2010 Movement Disorder Society
ISSN:0885-3185
1531-8257
DOI:10.1002/mds.23006