Cancer incidence in a trial of an antiapoptotic agent for Parkinson's disease
Identifieur interne : 000024 ( Istex/Corpus ); précédent : 000023; suivant : 000025Cancer incidence in a trial of an antiapoptotic agent for Parkinson's disease
Auteurs : Steven Schwid ; Janice Bausch ; David Oakes ; Lynn Schuchter ; Caroline Tanner ; Misser Forrest ; Anthony Lang ; Ira ShoulsonSource :
- Movement Disorders [ 0885-3185 ] ; 2010-09-15.
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- KwdEn :
Abstract
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
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DOI: 10.1002/mds.23006
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<titleGroup><title type="main" xml:lang="en">Cancer incidence in a trial of an antiapoptotic agent for Parkinson's disease<link href="#fn7"></link>
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<title type="short" xml:lang="en">Cancer Incidence in Parkinson's Disease</title>
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<creators><creator xml:id="au1" creatorRole="author" affiliationRef="#af1" noteRef="#fn8"><personName><givenNames>Steven R.</givenNames>
<familyName>Schwid</familyName>
<degrees>MD</degrees>
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<creator xml:id="au2" creatorRole="author" affiliationRef="#af2"><personName><givenNames>Janice</givenNames>
<familyName>Bausch</familyName>
<degrees>BS</degrees>
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<creator xml:id="au3" creatorRole="author" affiliationRef="#af2"><personName><givenNames>David</givenNames>
<familyName>Oakes</familyName>
<degrees>PhD</degrees>
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<creator xml:id="au4" creatorRole="author" affiliationRef="#af3"><personName><givenNames>Lynn</givenNames>
<familyName>Schuchter</familyName>
<degrees>MD</degrees>
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<creator xml:id="au5" creatorRole="author" affiliationRef="#af4"><personName><givenNames>Caroline</givenNames>
<familyName>Tanner</familyName>
<degrees>MD</degrees>
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<familyName>Forrest</familyName>
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<creator xml:id="au7" creatorRole="author" affiliationRef="#af6" corresponding="yes"><personName><givenNames>Anthony E.</givenNames>
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<familyName>Shoulson</familyName>
<degrees>MD</degrees>
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</creator>
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<keyword xml:id="kwd3">L‐dopa</keyword>
<keyword xml:id="kwd4">Parkinson's disease</keyword>
<keyword xml:id="kwd5">apoptosis</keyword>
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<abstractGroup><abstract type="main" xml:lang="en"><title type="main">Abstract</title>
<p>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 <i>P</i>
> 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</p>
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<noteGroup><note xml:id="fn7"><p>Potential conflict of interest: Nothing to report.</p>
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<note xml:id="fn8"><p>Deceased.</p>
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<name type="personal"><namePart type="given">Steven R.</namePart>
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<affiliation>Department of Neurology, University of Rochester, Rochester, New York</affiliation>
<description>Deceased.</description>
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<name type="personal"><namePart type="given">David</namePart>
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<name type="personal"><namePart type="given">Anthony E.</namePart>
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<name type="corporate"><namePart>the PSG PRECEPT Investigators</namePart>
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<affiliation>Department of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania</affiliation>
<affiliation>Department of Clinical Research, Parkinson's Institute, Sunnyvale, California</affiliation>
<affiliation>H. Lundbeck A/S, Copenhagen, Denmark</affiliation>
<affiliation>Division of Neurology, Toronto Western Hospital, Toronto, Ontario</affiliation>
<description>Department of Neurology, University of Rochester, Rochester, New YorkDepartment of Biostatistics and Computational Biology, University of Rochester, Rochester, New YorkDepartment of Medicine, University of Pennsylvania, Philadelphia, PennsylvaniaDepartment of Clinical Research, Parkinson's Institute, Sunnyvale, CaliforniaH. Lundbeck A/S, Copenhagen, DenmarkDivision of Neurology, Toronto Western Hospital, Toronto, Ontario</description>
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<abstract lang="en">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</abstract>
<note type="content">*Potential conflict of interest: Nothing to report.</note>
<subject lang="en"><genre>Keywords</genre>
<topic>Melanoma</topic>
<topic>cancer</topic>
<topic>L‐dopa</topic>
<topic>Parkinson's disease</topic>
<topic>apoptosis</topic>
</subject>
<relatedItem type="host"><titleInfo><title>Movement Disorders</title>
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<identifier type="ISSN">0885-3185</identifier>
<identifier type="eISSN">1531-8257</identifier>
<identifier type="DOI">10.1002/(ISSN)1531-8257</identifier>
<identifier type="PublisherID">MDS</identifier>
<part><date>2010</date>
<detail type="volume"><caption>vol.</caption>
<number>25</number>
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<detail type="issue"><caption>no.</caption>
<number>12</number>
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<extent unit="pages"><start>1801</start>
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