Modelling the Survival Outcomes of Immuno-Oncology Drugs in Economic Evaluations: A Systematic Approach to Data Analysis and Extrapolation.
Identifieur interne : 004D89 ( Ncbi/Merge ); précédent : 004D88; suivant : 004D90Modelling the Survival Outcomes of Immuno-Oncology Drugs in Economic Evaluations: A Systematic Approach to Data Analysis and Extrapolation.
Auteurs : Eddie Gibson [Royaume-Uni] ; Ian Koblbauer [Royaume-Uni] ; Najida Begum [Royaume-Uni] ; George Dranitsaris [Canada] ; Danny Liew [Australie] ; Phil Mcewan [Royaume-Uni] ; Amir Abbas Tahami Monfared [Canada] ; Yong Yuan [États-Unis] ; Ariadna Juarez-Garcia [Mexique] ; David Tyas [Royaume-Uni] ; Michael Lees [France]Source :
- 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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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 wicri:level="3"><nlm:affiliation>Wickenstones Ltd, Oxford, UK. 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Melbourne, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Monash University, Melbourne</wicri:regionArea><placeName><settlement type="city">Melbourne</settlement><region type="état">Victoria (État)</region></placeName></affiliation></author><author><name sortKey="Mcewan, Phil" sort="Mcewan, Phil" uniqKey="Mcewan P" first="Phil" last="Mcewan">Phil Mcewan</name><affiliation wicri:level="1"><nlm:affiliation>Health Economics and Outcomes Research Ltd, Cardiff, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Health Economics and Outcomes Research Ltd, Cardiff</wicri:regionArea><wicri:noRegion>Cardiff</wicri:noRegion></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 wicri:level="3"><nlm:affiliation>Bristol-Myers Squibb, Montreal, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>Bristol-Myers Squibb, Montreal</wicri:regionArea><placeName><settlement type="city">Montréal</settlement><region type="state">Québec</region></placeName></affiliation></author><author><name sortKey="Yuan, Yong" sort="Yuan, Yong" uniqKey="Yuan Y" first="Yong" last="Yuan">Yong Yuan</name><affiliation wicri:level="2"><nlm:affiliation>Bristol-Myers Squibb, New Jersey, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Bristol-Myers Squibb, New Jersey</wicri:regionArea><placeName><region type="state">New Jersey</region></placeName></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 wicri:level="1"><nlm:affiliation>Bristol-Myers Squibb, Mexico City, Mexico.</nlm:affiliation><country xml:lang="fr">Mexique</country><wicri:regionArea>Bristol-Myers Squibb, Mexico City</wicri:regionArea><wicri:noRegion>Mexico City</wicri:noRegion></affiliation></author><author><name sortKey="Tyas, David" sort="Tyas, David" uniqKey="Tyas D" first="David" last="Tyas">David Tyas</name><affiliation wicri:level="3"><nlm:affiliation>Bristol-Myers Squibb, London, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Bristol-Myers Squibb, London</wicri:regionArea><placeName><settlement type="city">Londres</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Grand Londres</region></placeName></affiliation></author><author><name sortKey="Lees, Michael" sort="Lees, Michael" uniqKey="Lees M" first="Michael" last="Lees">Michael Lees</name><affiliation wicri:level="3"><nlm:affiliation>Bristol-Myers Squibb, Paris, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Bristol-Myers Squibb, Paris</wicri:regionArea><placeName><region type="region">Île-de-France</region><region type="old region">Île-de-France</region><settlement type="city">Paris</settlement></placeName></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><affiliations><list><country><li>Australie</li><li>Canada</li><li>France</li><li>Mexique</li><li>Royaume-Uni</li><li>États-Unis</li></country><region><li>Angleterre</li><li>Grand Londres</li><li>New Jersey</li><li>Oxfordshire</li><li>Québec</li><li>Victoria (État)</li><li>Île-de-France</li></region><settlement><li>Londres</li><li>Melbourne</li><li>Montréal</li><li>Oxford</li><li>Paris</li></settlement></list><tree><country name="Royaume-Uni"><region name="Angleterre"><name sortKey="Gibson, Eddie" sort="Gibson, Eddie" uniqKey="Gibson E" first="Eddie" last="Gibson">Eddie Gibson</name></region><name sortKey="Begum, Najida" sort="Begum, Najida" uniqKey="Begum N" first="Najida" last="Begum">Najida Begum</name><name sortKey="Koblbauer, Ian" sort="Koblbauer, Ian" uniqKey="Koblbauer I" first="Ian" last="Koblbauer">Ian Koblbauer</name><name sortKey="Mcewan, Phil" sort="Mcewan, Phil" uniqKey="Mcewan P" first="Phil" last="Mcewan">Phil Mcewan</name><name sortKey="Tyas, David" sort="Tyas, David" uniqKey="Tyas D" first="David" last="Tyas">David Tyas</name></country><country name="Canada"><noRegion><name sortKey="Dranitsaris, George" sort="Dranitsaris, George" uniqKey="Dranitsaris G" first="George" last="Dranitsaris">George Dranitsaris</name></noRegion><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></country><country name="Australie"><region name="Victoria (État)"><name sortKey="Liew, Danny" sort="Liew, Danny" uniqKey="Liew D" first="Danny" last="Liew">Danny Liew</name></region></country><country name="États-Unis"><region name="New Jersey"><name sortKey="Yuan, Yong" sort="Yuan, Yong" uniqKey="Yuan Y" first="Yong" last="Yuan">Yong Yuan</name></region></country><country name="Mexique"><noRegion><name sortKey="Juarez Garcia, Ariadna" sort="Juarez Garcia, Ariadna" uniqKey="Juarez Garcia A" first="Ariadna" last="Juarez-Garcia">Ariadna Juarez-Garcia</name></noRegion></country><country name="France"><region name="Île-de-France"><name sortKey="Lees, Michael" sort="Lees, Michael" uniqKey="Lees M" first="Michael" last="Lees">Michael Lees</name></region></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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