Modelling the Survival Outcomes of Immuno-Oncology Drugs in Economic Evaluations: A Systematic Approach to Data Analysis and Extrapolation.
Identifieur interne : 000186 ( PubMed/Corpus ); précédent : 000185; suivant : 000187Modelling the Survival Outcomes of Immuno-Oncology Drugs in Economic Evaluations: A Systematic Approach to Data Analysis and Extrapolation.
Auteurs : Eddie Gibson ; Ian Koblbauer ; Najida Begum ; George Dranitsaris ; Danny Liew ; Phil Mcewan ; Amir Abbas Tahami Monfared ; Yong Yuan ; Ariadna Juarez-Garcia ; David Tyas ; Michael LeesSource :
- PharmacoEconomics [ 1179-2027 ] ; 2017.
Abstract
New immuno-oncology (I-O) therapies that harness the immune system to fight cancer call for a re-examination of the traditional parametric techniques used to model survival from clinical trial data. More flexible approaches are needed to capture the characteristic I-O pattern of delayed treatment effects and, for a subset of patients, the plateau of long-term survival.
DOI: 10.1007/s40273-017-0558-5
PubMed: 28866758
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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Modelling the Survival Outcomes of Immuno-Oncology Drugs in Economic Evaluations: A Systematic Approach to Data Analysis and Extrapolation.</title><author><name sortKey="Gibson, Eddie" sort="Gibson, Eddie" uniqKey="Gibson E" first="Eddie" last="Gibson">Eddie Gibson</name><affiliation><nlm:affiliation>Wickenstones Ltd, Oxford, UK. Eddie@wickenstones.com.</nlm:affiliation></affiliation></author><author><name sortKey="Koblbauer, Ian" sort="Koblbauer, Ian" uniqKey="Koblbauer I" first="Ian" last="Koblbauer">Ian Koblbauer</name><affiliation><nlm:affiliation>Wickenstones Ltd, Oxford, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Begum, Najida" sort="Begum, Najida" uniqKey="Begum N" first="Najida" last="Begum">Najida Begum</name><affiliation><nlm:affiliation>Wickenstones Ltd, Oxford, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Dranitsaris, George" sort="Dranitsaris, George" uniqKey="Dranitsaris G" first="George" last="Dranitsaris">George Dranitsaris</name><affiliation><nlm:affiliation>Augmentium Pharma Consulting Inc., Toronto, Canada.</nlm:affiliation></affiliation></author><author><name sortKey="Liew, Danny" sort="Liew, Danny" uniqKey="Liew D" first="Danny" last="Liew">Danny Liew</name><affiliation><nlm:affiliation>Monash University, Melbourne, Australia.</nlm:affiliation></affiliation></author><author><name sortKey="Mcewan, Phil" sort="Mcewan, Phil" uniqKey="Mcewan P" first="Phil" last="Mcewan">Phil Mcewan</name><affiliation><nlm:affiliation>Health Economics and Outcomes Research Ltd, Cardiff, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Tahami Monfared, Amir Abbas" sort="Tahami Monfared, Amir Abbas" uniqKey="Tahami Monfared A" first="Amir Abbas" last="Tahami Monfared">Amir Abbas Tahami Monfared</name><affiliation><nlm:affiliation>Bristol-Myers Squibb, Montreal, Canada.</nlm:affiliation></affiliation></author><author><name sortKey="Yuan, Yong" sort="Yuan, Yong" uniqKey="Yuan Y" first="Yong" last="Yuan">Yong Yuan</name><affiliation><nlm:affiliation>Bristol-Myers Squibb, New Jersey, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Juarez Garcia, Ariadna" sort="Juarez Garcia, Ariadna" uniqKey="Juarez Garcia A" first="Ariadna" last="Juarez-Garcia">Ariadna Juarez-Garcia</name><affiliation><nlm:affiliation>Bristol-Myers Squibb, Mexico City, Mexico.</nlm:affiliation></affiliation></author><author><name sortKey="Tyas, David" sort="Tyas, David" uniqKey="Tyas D" first="David" last="Tyas">David Tyas</name><affiliation><nlm:affiliation>Bristol-Myers Squibb, London, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Lees, Michael" sort="Lees, Michael" uniqKey="Lees M" first="Michael" last="Lees">Michael Lees</name><affiliation><nlm:affiliation>Bristol-Myers Squibb, Paris, France.</nlm:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2017">2017</date><idno type="RBID">pubmed:28866758</idno><idno type="pmid">28866758</idno><idno type="doi">10.1007/s40273-017-0558-5</idno><idno type="wicri:Area/PubMed/Corpus">000186</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">000186</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Modelling the Survival Outcomes of Immuno-Oncology Drugs in Economic Evaluations: A Systematic Approach to Data Analysis and Extrapolation.</title><author><name sortKey="Gibson, Eddie" sort="Gibson, Eddie" uniqKey="Gibson E" first="Eddie" last="Gibson">Eddie Gibson</name><affiliation><nlm:affiliation>Wickenstones Ltd, Oxford, UK. Eddie@wickenstones.com.</nlm:affiliation></affiliation></author><author><name sortKey="Koblbauer, Ian" sort="Koblbauer, Ian" uniqKey="Koblbauer I" first="Ian" last="Koblbauer">Ian Koblbauer</name><affiliation><nlm:affiliation>Wickenstones Ltd, Oxford, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Begum, Najida" sort="Begum, Najida" uniqKey="Begum N" first="Najida" last="Begum">Najida Begum</name><affiliation><nlm:affiliation>Wickenstones Ltd, Oxford, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Dranitsaris, George" sort="Dranitsaris, George" uniqKey="Dranitsaris G" first="George" last="Dranitsaris">George Dranitsaris</name><affiliation><nlm:affiliation>Augmentium Pharma Consulting Inc., Toronto, Canada.</nlm:affiliation></affiliation></author><author><name sortKey="Liew, Danny" sort="Liew, Danny" uniqKey="Liew D" first="Danny" last="Liew">Danny Liew</name><affiliation><nlm:affiliation>Monash University, Melbourne, Australia.</nlm:affiliation></affiliation></author><author><name sortKey="Mcewan, Phil" sort="Mcewan, Phil" uniqKey="Mcewan P" first="Phil" last="Mcewan">Phil Mcewan</name><affiliation><nlm:affiliation>Health Economics and Outcomes Research Ltd, Cardiff, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Tahami Monfared, Amir Abbas" sort="Tahami Monfared, Amir Abbas" uniqKey="Tahami Monfared A" first="Amir Abbas" last="Tahami Monfared">Amir Abbas Tahami Monfared</name><affiliation><nlm:affiliation>Bristol-Myers Squibb, Montreal, Canada.</nlm:affiliation></affiliation></author><author><name sortKey="Yuan, Yong" sort="Yuan, Yong" uniqKey="Yuan Y" first="Yong" last="Yuan">Yong Yuan</name><affiliation><nlm:affiliation>Bristol-Myers Squibb, New Jersey, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Juarez Garcia, Ariadna" sort="Juarez Garcia, Ariadna" uniqKey="Juarez Garcia A" first="Ariadna" last="Juarez-Garcia">Ariadna Juarez-Garcia</name><affiliation><nlm:affiliation>Bristol-Myers Squibb, Mexico City, Mexico.</nlm:affiliation></affiliation></author><author><name sortKey="Tyas, David" sort="Tyas, David" uniqKey="Tyas D" first="David" last="Tyas">David Tyas</name><affiliation><nlm:affiliation>Bristol-Myers Squibb, London, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Lees, Michael" sort="Lees, Michael" uniqKey="Lees M" first="Michael" last="Lees">Michael Lees</name><affiliation><nlm:affiliation>Bristol-Myers Squibb, Paris, France.</nlm:affiliation></affiliation></author></analytic><series><title level="j">PharmacoEconomics</title><idno type="eISSN">1179-2027</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">New immuno-oncology (I-O) therapies that harness the immune system to fight cancer call for a re-examination of the traditional parametric techniques used to model survival from clinical trial data. More flexible approaches are needed to capture the characteristic I-O pattern of delayed treatment effects and, for a subset of patients, the plateau of long-term survival.</div></front></TEI><pubmed><MedlineCitation Status="In-Process" Owner="NLM"><PMID Version="1">28866758</PMID><DateCreated><Year>2017</Year><Month>09</Month><Day>03</Day></DateCreated><DateRevised><Year>2017</Year><Month>11</Month><Day>14</Day></DateRevised><Article PubModel="Print"><Journal><ISSN IssnType="Electronic">1179-2027</ISSN><JournalIssue CitedMedium="Internet"><Volume>35</Volume><Issue>12</Issue><PubDate><Year>2017</Year><Month>Dec</Month></PubDate></JournalIssue><Title>PharmacoEconomics</Title><ISOAbbreviation>Pharmacoeconomics</ISOAbbreviation></Journal><ArticleTitle>Modelling the Survival Outcomes of Immuno-Oncology Drugs in Economic Evaluations: A Systematic Approach to Data Analysis and Extrapolation.</ArticleTitle><Pagination><MedlinePgn>1257-1270</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1007/s40273-017-0558-5</ELocationID><Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">New immuno-oncology (I-O) therapies that harness the immune system to fight cancer call for a re-examination of the traditional parametric techniques used to model survival from clinical trial data. More flexible approaches are needed to capture the characteristic I-O pattern of delayed treatment effects and, for a subset of patients, the plateau of long-term survival.</AbstractText><AbstractText Label="OBJECTIVES" NlmCategory="OBJECTIVE">Using a systematic approach to data management and analysis, the study assessed the applicability of traditional and flexible approaches and, as a test case of flexible methods, investigated the suitability of restricted cubic splines (RCS) to model progression-free survival (PFS) in I-O therapy.</AbstractText><AbstractText Label="METHODS" NlmCategory="METHODS">The goodness of fit of each survival function was tested on data from the CheckMate 067 trial of monotherapy versus combination therapy (nivolumab/ipilimumab) in metastatic melanoma using visual inspection and statistical tests. Extrapolations were validated using long-term data for ipilimumab.</AbstractText><AbstractText Label="RESULTS" NlmCategory="RESULTS">Modelled PFS estimates using traditional methods did not provide a good fit to the Kaplan-Meier (K-M) curve. RCS estimates fit the K-M curves well, particularly for the plateau phase. RCS with six knots provided the best overall fit, but RCS with one knot performed best at the plateau phase and was preferred on the grounds of parsimony.</AbstractText><AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">RCS models represent a valuable addition to the range of flexible approaches available to model survival when assessing the effectiveness and cost-effectiveness of I-O therapy. A systematic approach to data analysis is recommended to compare the suitability of different approaches for different diseases and treatment regimens.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Gibson</LastName><ForeName>Eddie</ForeName><Initials>E</Initials><AffiliationInfo><Affiliation>Wickenstones Ltd, Oxford, UK. Eddie@wickenstones.com.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Koblbauer</LastName><ForeName>Ian</ForeName><Initials>I</Initials><AffiliationInfo><Affiliation>Wickenstones Ltd, Oxford, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Begum</LastName><ForeName>Najida</ForeName><Initials>N</Initials><AffiliationInfo><Affiliation>Wickenstones Ltd, Oxford, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Dranitsaris</LastName><ForeName>George</ForeName><Initials>G</Initials><AffiliationInfo><Affiliation>Augmentium Pharma Consulting Inc., Toronto, Canada.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Liew</LastName><ForeName>Danny</ForeName><Initials>D</Initials><AffiliationInfo><Affiliation>Monash University, Melbourne, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>McEwan</LastName><ForeName>Phil</ForeName><Initials>P</Initials><AffiliationInfo><Affiliation>Health Economics and Outcomes Research Ltd, Cardiff, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Tahami Monfared</LastName><ForeName>Amir Abbas</ForeName><Initials>AA</Initials><AffiliationInfo><Affiliation>Bristol-Myers Squibb, Montreal, Canada.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal, Canada.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Yuan</LastName><ForeName>Yong</ForeName><Initials>Y</Initials><AffiliationInfo><Affiliation>Bristol-Myers Squibb, New Jersey, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Juarez-Garcia</LastName><ForeName>Ariadna</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Bristol-Myers Squibb, Mexico City, Mexico.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Tyas</LastName><ForeName>David</ForeName><Initials>D</Initials><AffiliationInfo><Affiliation>Bristol-Myers Squibb, London, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Lees</LastName><ForeName>Michael</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Bristol-Myers Squibb, Paris, France.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType></PublicationTypeList></Article><MedlineJournalInfo><Country>New Zealand</Country><MedlineTA>Pharmacoeconomics</MedlineTA><NlmUniqueID>9212404</NlmUniqueID><ISSNLinking>1170-7690</ISSNLinking></MedlineJournalInfo></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="pubmed"><Year>2017</Year><Month>9</Month><Day>4</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2017</Year><Month>9</Month><Day>4</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2017</Year><Month>9</Month><Day>4</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">28866758</ArticleId><ArticleId IdType="doi">10.1007/s40273-017-0558-5</ArticleId><ArticleId IdType="pii">10.1007/s40273-017-0558-5</ArticleId></ArticleIdList></PubmedData></pubmed></record>Pour manipuler ce document sous Unix (Dilib)
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