Changes in the use of end points in clinical trials for elderly cancer patients over time.
Identifieur interne : 004F58 ( Ncbi/Merge ); précédent : 004F57; suivant : 004F59Changes in the use of end points in clinical trials for elderly cancer patients over time.
Auteurs : O. Le Saux ; C. Falandry ; H K Gan ; B. You ; G. Freyer ; J. PéronSource :
- Annals of oncology : official journal of the European Society for Medical Oncology [ 1569-8041 ] ; 2017.
Abstract
Physicians need well-addressed clinical trials assessing benefits and harm of treatments to avoid under-treatment or over-treatment of elderly patients. The main objectives of this report were to present an overview of end points used in clinical trials dedicated to elderly patients; and to assess the evolution in chosen end points before and after the creation of the International Society of Geriatric Oncology in the early 2000s.
DOI: 10.1093/annonc/mdx354
PubMed: 28961850
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Falandry</name><affiliation><nlm:affiliation>Geriatric Oncology Department, Centre Hospitalier Lyon Sud, Pierre-Bénite.</nlm:affiliation><wicri:noCountry code="subField">Pierre-Bénite</wicri:noCountry></affiliation></author><author><name sortKey="Gan, H K" sort="Gan, H K" uniqKey="Gan H" first="H K" last="Gan">H K Gan</name><affiliation><nlm:affiliation>Olivia Newton-John Cancer Research Institute, Heidelberg.</nlm:affiliation><wicri:noCountry code="subField">Heidelberg</wicri:noCountry></affiliation></author><author><name sortKey="You, B" sort="You, B" uniqKey="You B" first="B" last="You">B. You</name><affiliation><nlm:affiliation>Medical Oncology Department, Institut de Cancérologie des Hospices Civils de Lyon (IC-HCL), Pierre-Bénite.</nlm:affiliation><wicri:noCountry code="subField">Pierre-Bénite</wicri:noCountry></affiliation></author><author><name sortKey="Freyer, G" sort="Freyer, G" uniqKey="Freyer G" first="G" last="Freyer">G. Freyer</name><affiliation><nlm:affiliation>Medical Oncology Department, Institut de Cancérologie des Hospices Civils de Lyon (IC-HCL), Pierre-Bénite.</nlm:affiliation><wicri:noCountry code="subField">Pierre-Bénite</wicri:noCountry></affiliation></author><author><name sortKey="Peron, J" sort="Peron, J" uniqKey="Peron J" first="J" last="Péron">J. Péron</name><affiliation><nlm:affiliation>Medical Oncology Department, Institut de Cancérologie des Hospices Civils de Lyon (IC-HCL), Pierre-Bénite.</nlm:affiliation><wicri:noCountry code="subField">Pierre-Bénite</wicri:noCountry></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2017">2017</date><idno type="RBID">pubmed:28961850</idno><idno type="pmid">28961850</idno><idno type="doi">10.1093/annonc/mdx354</idno><idno type="wicri:Area/PubMed/Corpus">000277</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">000277</idno><idno type="wicri:Area/PubMed/Curation">000275</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Curation">000275</idno><idno type="wicri:Area/PubMed/Checkpoint">000275</idno><idno type="wicri:explorRef" wicri:stream="Checkpoint" wicri:step="PubMed">000275</idno><idno type="wicri:Area/Ncbi/Merge">004F58</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Changes in the use of end points in clinical trials for elderly cancer patients over time.</title><author><name sortKey="Le Saux, O" sort="Le Saux, O" uniqKey="Le Saux O" first="O" last="Le Saux">O. Le Saux</name><affiliation><nlm:affiliation>Medical Oncology Department, Institut de Cancérologie des Hospices Civils de Lyon (IC-HCL), Pierre-Bénite.</nlm:affiliation><wicri:noCountry code="subField">Pierre-Bénite</wicri:noCountry></affiliation></author><author><name sortKey="Falandry, C" sort="Falandry, C" uniqKey="Falandry C" first="C" last="Falandry">C. Falandry</name><affiliation><nlm:affiliation>Geriatric Oncology Department, Centre Hospitalier Lyon Sud, Pierre-Bénite.</nlm:affiliation><wicri:noCountry code="subField">Pierre-Bénite</wicri:noCountry></affiliation></author><author><name sortKey="Gan, H K" sort="Gan, H K" uniqKey="Gan H" first="H K" last="Gan">H K Gan</name><affiliation><nlm:affiliation>Olivia Newton-John Cancer Research Institute, Heidelberg.</nlm:affiliation><wicri:noCountry code="subField">Heidelberg</wicri:noCountry></affiliation></author><author><name sortKey="You, B" sort="You, B" uniqKey="You B" first="B" last="You">B. You</name><affiliation><nlm:affiliation>Medical Oncology Department, Institut de Cancérologie des Hospices Civils de Lyon (IC-HCL), Pierre-Bénite.</nlm:affiliation><wicri:noCountry code="subField">Pierre-Bénite</wicri:noCountry></affiliation></author><author><name sortKey="Freyer, G" sort="Freyer, G" uniqKey="Freyer G" first="G" last="Freyer">G. Freyer</name><affiliation><nlm:affiliation>Medical Oncology Department, Institut de Cancérologie des Hospices Civils de Lyon (IC-HCL), Pierre-Bénite.</nlm:affiliation><wicri:noCountry code="subField">Pierre-Bénite</wicri:noCountry></affiliation></author><author><name sortKey="Peron, J" sort="Peron, J" uniqKey="Peron J" first="J" last="Péron">J. Péron</name><affiliation><nlm:affiliation>Medical Oncology Department, Institut de Cancérologie des Hospices Civils de Lyon (IC-HCL), Pierre-Bénite.</nlm:affiliation><wicri:noCountry code="subField">Pierre-Bénite</wicri:noCountry></affiliation></author></analytic><series><title level="j">Annals of oncology : official journal of the European Society for Medical Oncology</title><idno type="eISSN">1569-8041</idno><imprint><date when="2017" type="published">2017</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Physicians need well-addressed clinical trials assessing benefits and harm of treatments to avoid under-treatment or over-treatment of elderly patients. The main objectives of this report were to present an overview of end points used in clinical trials dedicated to elderly patients; and to assess the evolution in chosen end points before and after the creation of the International Society of Geriatric Oncology in the early 2000s.</div></front></TEI><pubmed><MedlineCitation Status="In-Process" Owner="NLM"><PMID Version="1">28961850</PMID><DateCreated><Year>2017</Year><Month>09</Month><Day>29</Day></DateCreated><DateRevised><Year>2017</Year><Month>09</Month><Day>29</Day></DateRevised><Article PubModel="Print"><Journal><ISSN IssnType="Electronic">1569-8041</ISSN><JournalIssue CitedMedium="Internet"><Volume>28</Volume><Issue>10</Issue><PubDate><Year>2017</Year><Month>Oct</Month><Day>01</Day></PubDate></JournalIssue><Title>Annals of oncology : official journal of the European Society for Medical Oncology</Title><ISOAbbreviation>Ann. Oncol.</ISOAbbreviation></Journal><ArticleTitle>Changes in the use of end points in clinical trials for elderly cancer patients over time.</ArticleTitle><Pagination><MedlinePgn>2606-2611</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1093/annonc/mdx354</ELocationID><Abstract><AbstractText Label="Background" NlmCategory="UNASSIGNED">Physicians need well-addressed clinical trials assessing benefits and harm of treatments to avoid under-treatment or over-treatment of elderly patients. The main objectives of this report were to present an overview of end points used in clinical trials dedicated to elderly patients; and to assess the evolution in chosen end points before and after the creation of the International Society of Geriatric Oncology in the early 2000s.</AbstractText><AbstractText Label="Patients and methods" NlmCategory="UNASSIGNED">All phases I, II and III trials dedicated to the treatment of cancer among elderly patients published between 2001 and 2004 and between 2011 and 2014 were reviewed. All phase III clinical trials assessing cancer treatments among adults in the same periods were also reviewed to identify subgroup analyses of elderly patients among these trials.</AbstractText><AbstractText Label="Results" NlmCategory="UNASSIGNED">Among phase III trials dedicated to elderly patients, overall survival was a common primary end point. Interestingly, tumor centered end points were very common in the first time period and very uncommon in the second time period, whereas composite end points were very uncommon in the first time period but very common in the second time period. Concerningly, disease-specific survival was very infrequently reported in dedicated clinical trials of elderly patients despite their importance in evaluating competing risk of death from non-oncology causes. The use of patient-reported outcomes (PROs) as a primary end point remained very uncommon but the reporting of PROs as a secondary end point tended to increase in the second time period, from 19% to 33% (P = 0.10). Functional status was infrequently reported.</AbstractText><AbstractText Label="Conclusion" NlmCategory="UNASSIGNED">During the past decade, the use of clinically meaningful end points such as PROs and functional status in elderly patients remained moderate. Yet, the use of PROs as a secondary end point tended to increase between the two time periods.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Le Saux</LastName><ForeName>O</ForeName><Initials>O</Initials><AffiliationInfo><Affiliation>Medical Oncology Department, Institut de Cancérologie des Hospices Civils de Lyon (IC-HCL), Pierre-Bénite.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Faculté de Médecine Lyon-Sud, Lyon 1 University, EMR 3738, Oullins.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Falandry</LastName><ForeName>C</ForeName><Initials>C</Initials><AffiliationInfo><Affiliation>Geriatric Oncology Department, Centre Hospitalier Lyon Sud, Pierre-Bénite.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>CarMen Biomedical Research Laboratory (Cardiovascular Diseases, Metabolism, Diabetology and Nutrition) INSERM UMR 1060, Université de Lyon, Oullins, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Gan</LastName><ForeName>H K</ForeName><Initials>HK</Initials><AffiliationInfo><Affiliation>Olivia Newton-John Cancer Research Institute, Heidelberg.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>School of Cancer Medicine, La Trobe University, Heidelberg.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Department of Medicine, Melbourne University, Melbourne, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>You</LastName><ForeName>B</ForeName><Initials>B</Initials><AffiliationInfo><Affiliation>Medical Oncology Department, Institut de Cancérologie des Hospices Civils de Lyon (IC-HCL), Pierre-Bénite.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Faculté de Médecine Lyon-Sud, Lyon 1 University, EMR 3738, Oullins.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Freyer</LastName><ForeName>G</ForeName><Initials>G</Initials><AffiliationInfo><Affiliation>Medical Oncology Department, Institut de Cancérologie des Hospices Civils de Lyon (IC-HCL), Pierre-Bénite.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Faculté de Médecine Lyon-Sud, Lyon 1 University, EMR 3738, Oullins.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Péron</LastName><ForeName>J</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Medical Oncology Department, Institut de Cancérologie des Hospices Civils de Lyon (IC-HCL), Pierre-Bénite.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Statistics Unit, Hospices Civils de Lyon, Pierre-Bénite.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>CNRS, UMR 5558 Biometry and Evolutionary Biology Laboratory, Université Lyon 1, Villeurbanne, France.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType></PublicationTypeList></Article><MedlineJournalInfo><Country>England</Country><MedlineTA>Ann Oncol</MedlineTA><NlmUniqueID>9007735</NlmUniqueID><ISSNLinking>0923-7534</ISSNLinking></MedlineJournalInfo><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">elderly</Keyword><Keyword MajorTopicYN="N">end points</Keyword><Keyword MajorTopicYN="N">geriatric oncology</Keyword><Keyword MajorTopicYN="N">neoplasms</Keyword></KeywordList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="entrez"><Year>2017</Year><Month>9</Month><Day>30</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2017</Year><Month>9</Month><Day>30</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2017</Year><Month>9</Month><Day>30</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">28961850</ArticleId><ArticleId IdType="pii">4061260</ArticleId><ArticleId IdType="doi">10.1093/annonc/mdx354</ArticleId></ArticleIdList></PubmedData></pubmed><affiliations><list></list><tree><noCountry><name sortKey="Falandry, C" sort="Falandry, C" uniqKey="Falandry C" first="C" last="Falandry">C. Falandry</name><name sortKey="Freyer, G" sort="Freyer, G" uniqKey="Freyer G" first="G" last="Freyer">G. Freyer</name><name sortKey="Gan, H K" sort="Gan, H K" uniqKey="Gan H" first="H K" last="Gan">H K Gan</name><name sortKey="Le Saux, O" sort="Le Saux, O" uniqKey="Le Saux O" first="O" last="Le Saux">O. Le Saux</name><name sortKey="Peron, J" sort="Peron, J" uniqKey="Peron J" first="J" last="Péron">J. Péron</name><name sortKey="You, B" sort="You, B" uniqKey="You B" first="B" last="You">B. You</name></noCountry></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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