VESPRO: An Individual Patient Data Prospective Meta-Analysis of Selective Internal Radiation Therapy Versus Sorafenib for Advanced, Locally Advanced, or Recurrent Hepatocellular Carcinoma of the SARAH and SIRveNIB Trials.
Identifieur interne : 001060 ( PubMed/Curation ); précédent : 001059; suivant : 001061VESPRO: An Individual Patient Data Prospective Meta-Analysis of Selective Internal Radiation Therapy Versus Sorafenib for Advanced, Locally Advanced, or Recurrent Hepatocellular Carcinoma of the SARAH and SIRveNIB Trials.
Auteurs : Val Gebski [Australie] ; Emma Gibbs [Australie] ; Mihir Gandhi [Singapour] ; Gilles Chatellier [France] ; Aurelia Dinut [France] ; Helena Pereira [France] ; Pierce Kh Chow [Singapour] ; Valérie Vilgrain [France]Source :
- JMIR research protocols [ 1929-0748 ] ; 2017.
Abstract
Untreated advanced hepatocellular carcinoma (HCC) has an overall poor prognosis. Currently there are 2 ongoing prospective randomized controlled trials that are evaluating the efficacy and safety of sorafenib and selective internal radiation therapy (SIRT) with yttrium-90 resin microspheres in patients with advanced HCC. The SorAfenib versus Radioembolisation in Advanced Hepatocellular carcinoma (SARAH; 459 patients) trial is being performed in Europe and the SIRt VErsus SorafeNIB (SIRveNIB; 360 patients) trial in the Asia Pacific region. Prospectively combining the results, these trials will not only allow for increased precision to estimate efficacy (in terms of survival), but will also provide increased statistical power for subgroup analyses.
DOI: 10.2196/resprot.7016
PubMed: 28202430
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xml:lang="fr">Australie</country><wicri:regionArea>NHMRC Clinical Trials Centre, University of Sydney, Camperdown</wicri:regionArea></affiliation></author><author><name sortKey="Gandhi, Mihir" sort="Gandhi, Mihir" uniqKey="Gandhi M" first="Mihir" last="Gandhi">Mihir Gandhi</name><affiliation wicri:level="1"><nlm:affiliation>Biostatistics, Singapore Clinical Research Institute, Singapore, Singapore.</nlm:affiliation><country xml:lang="fr">Singapour</country><wicri:regionArea>Biostatistics, Singapore Clinical Research Institute, Singapore</wicri:regionArea></affiliation></author><author><name sortKey="Chatellier, Gilles" sort="Chatellier, Gilles" uniqKey="Chatellier G" first="Gilles" last="Chatellier">Gilles Chatellier</name><affiliation wicri:level="1"><nlm:affiliation>Clinical Research Unit, Assistance Publique, Hôpitaux de Paris, Paris, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Clinical Research Unit, Assistance Publique, Hôpitaux de Paris, Paris</wicri:regionArea></affiliation></author><author><name sortKey="Dinut, Aurelia" sort="Dinut, Aurelia" uniqKey="Dinut A" first="Aurelia" last="Dinut">Aurelia Dinut</name><affiliation wicri:level="1"><nlm:affiliation>Clinical Research Unit, Assistance Publique, Hôpitaux de Paris, Paris, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Clinical Research Unit, Assistance Publique, Hôpitaux de Paris, Paris</wicri:regionArea></affiliation></author><author><name sortKey="Pereira, Helena" sort="Pereira, Helena" uniqKey="Pereira H" first="Helena" last="Pereira">Helena Pereira</name><affiliation wicri:level="1"><nlm:affiliation>Clinical Research Unit, Assistance Publique, Hôpitaux de Paris, Paris, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Clinical Research Unit, Assistance Publique, Hôpitaux de Paris, Paris</wicri:regionArea></affiliation></author><author><name sortKey="Chow, Pierce Kh" sort="Chow, Pierce Kh" 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Trials Centre, University Sydney, Camperdown</wicri:regionArea></affiliation></author><author><name sortKey="Gibbs, Emma" sort="Gibbs, Emma" uniqKey="Gibbs E" first="Emma" last="Gibbs">Emma Gibbs</name><affiliation wicri:level="1"><nlm:affiliation>NHMRC Clinical Trials Centre, University of Sydney, Camperdown, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>NHMRC Clinical Trials Centre, University of Sydney, Camperdown</wicri:regionArea></affiliation></author><author><name sortKey="Gandhi, Mihir" sort="Gandhi, Mihir" uniqKey="Gandhi M" first="Mihir" last="Gandhi">Mihir Gandhi</name><affiliation wicri:level="1"><nlm:affiliation>Biostatistics, Singapore Clinical Research Institute, Singapore, Singapore.</nlm:affiliation><country xml:lang="fr">Singapour</country><wicri:regionArea>Biostatistics, Singapore Clinical Research Institute, Singapore</wicri:regionArea></affiliation></author><author><name sortKey="Chatellier, Gilles" sort="Chatellier, Gilles" uniqKey="Chatellier G" first="Gilles" last="Chatellier">Gilles Chatellier</name><affiliation wicri:level="1"><nlm:affiliation>Clinical Research Unit, Assistance Publique, Hôpitaux de Paris, Paris, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Clinical Research Unit, Assistance Publique, Hôpitaux de Paris, Paris</wicri:regionArea></affiliation></author><author><name sortKey="Dinut, Aurelia" sort="Dinut, Aurelia" uniqKey="Dinut A" first="Aurelia" last="Dinut">Aurelia Dinut</name><affiliation wicri:level="1"><nlm:affiliation>Clinical Research Unit, Assistance Publique, Hôpitaux de Paris, Paris, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Clinical Research Unit, Assistance Publique, Hôpitaux de Paris, Paris</wicri:regionArea></affiliation></author><author><name sortKey="Pereira, Helena" sort="Pereira, Helena" uniqKey="Pereira H" first="Helena" last="Pereira">Helena Pereira</name><affiliation wicri:level="1"><nlm:affiliation>Clinical Research Unit, Assistance Publique, Hôpitaux de Paris, Paris, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Clinical Research Unit, Assistance Publique, Hôpitaux de Paris, Paris</wicri:regionArea></affiliation></author><author><name sortKey="Chow, Pierce Kh" sort="Chow, Pierce Kh" uniqKey="Chow P" first="Pierce Kh" last="Chow">Pierce Kh Chow</name><affiliation wicri:level="1"><nlm:affiliation>Division of Surgical Oncology, National Cancer Centre Singapore, Singapore, Singapore.</nlm:affiliation><country xml:lang="fr">Singapour</country><wicri:regionArea>Division of Surgical Oncology, National Cancer Centre Singapore, Singapore</wicri:regionArea></affiliation></author><author><name sortKey="Vilgrain, Valerie" sort="Vilgrain, Valerie" uniqKey="Vilgrain V" first="Valérie" last="Vilgrain">Valérie Vilgrain</name><affiliation wicri:level="1"><nlm:affiliation>Department of Radiology, Assistance Publique, Hôpitaux de Paris, Paris, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Department of Radiology, Assistance Publique, Hôpitaux de Paris, Paris</wicri:regionArea></affiliation></author></analytic><series><title level="j">JMIR research protocols</title><idno type="ISSN">1929-0748</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">Untreated advanced hepatocellular carcinoma (HCC) has an overall poor prognosis. Currently there are 2 ongoing prospective randomized controlled trials that are evaluating the efficacy and safety of sorafenib and selective internal radiation therapy (SIRT) with yttrium-90 resin microspheres in patients with advanced HCC. The SorAfenib versus Radioembolisation in Advanced Hepatocellular carcinoma (SARAH; 459 patients) trial is being performed in Europe and the SIRt VErsus SorafeNIB (SIRveNIB; 360 patients) trial in the Asia Pacific region. Prospectively combining the results, these trials will not only allow for increased precision to estimate efficacy (in terms of survival), but will also provide increased statistical power for subgroup analyses.</div></front></TEI><pubmed><MedlineCitation Status="PubMed-not-MEDLINE" Owner="NLM"><PMID Version="1">28202430</PMID><DateCreated><Year>2017</Year><Month>02</Month><Day>16</Day></DateCreated><DateRevised><Year>2017</Year><Month>08</Month><Day>16</Day></DateRevised><Article PubModel="Electronic"><Journal><ISSN IssnType="Print">1929-0748</ISSN><JournalIssue CitedMedium="Print"><Volume>6</Volume><Issue>2</Issue><PubDate><Year>2017</Year><Month>Feb</Month><Day>15</Day></PubDate></JournalIssue><Title>JMIR research protocols</Title><ISOAbbreviation>JMIR Res Protoc</ISOAbbreviation></Journal><ArticleTitle>VESPRO: An Individual Patient Data Prospective Meta-Analysis of Selective Internal Radiation Therapy Versus Sorafenib for Advanced, Locally Advanced, or Recurrent Hepatocellular Carcinoma of the SARAH and SIRveNIB Trials.</ArticleTitle><Pagination><MedlinePgn>e17</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.2196/resprot.7016</ELocationID><Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">Untreated advanced hepatocellular carcinoma (HCC) has an overall poor prognosis. Currently there are 2 ongoing prospective randomized controlled trials that are evaluating the efficacy and safety of sorafenib and selective internal radiation therapy (SIRT) with yttrium-90 resin microspheres in patients with advanced HCC. The SorAfenib versus Radioembolisation in Advanced Hepatocellular carcinoma (SARAH; 459 patients) trial is being performed in Europe and the SIRt VErsus SorafeNIB (SIRveNIB; 360 patients) trial in the Asia Pacific region. Prospectively combining the results, these trials will not only allow for increased precision to estimate efficacy (in terms of survival), but will also provide increased statistical power for subgroup analyses.</AbstractText><AbstractText Label="OBJECTIVE" NlmCategory="OBJECTIVE">To ensure the prospectivity and transparency of the meta-analysis.</AbstractText><AbstractText Label="METHODS" NlmCategory="METHODS">The sirVEnib and SARAH merge PROject (VESPRO) is an individual, patient-data prospective meta-analysis of the SIRveNIB and SARAH randomized trials. The VESPRO protocol includes prespecified hypotheses, inclusion criteria, and outcome measures. The primary outcome measure is overall survival and secondary outcomes include tumor response rate, progression-free survival, progression in the liver as first event, and disease control in the liver. Pooling of toxicity results will allow for robust safety profiles to be established for both therapies, and provides increased statistical power to investigate treatment effects in key subgroups. Analyses will be performed in the intent-to-treat population stratified by trial.</AbstractText><AbstractText Label="RESULTS" NlmCategory="RESULTS">Both studies are expected to demonstrate a survival benefit for SIRT together with a better toxicity profile compared with sorafenib. It is also anticipated that liver progression as the first event would be longer in the intervention compared with the control.</AbstractText><AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">As the results of the 2 trials are not yet known, the methodological strength is enhanced, as biases inherent in conventional meta-analyses are avoided. This has the effect of providing this meta-analysis with the advantages of a single, large,randomized study of 819 patients. It is anticipated that the SARAH and SIRveNIB trial results will be published separately and together with the combined meta-analysis results from VESPRO. The combined dataset will allow the effect of the interventions to be explored with improved reliability/precision with respect to prespecified patient and intervention-level characteristics.</AbstractText><AbstractText Label="TRIAL REGISTRATION" NlmCategory="BACKGROUND">Australian New Zealand Trials Registry: ACTRN12617000030370.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Gebski</LastName><ForeName>Val</ForeName><Initials>V</Initials><Identifier Source="ORCID">http://orcid.org/0000-0001-8748-1844</Identifier><AffiliationInfo><Affiliation>NHMRC Clinical Trials Centre, University Sydney, Camperdown, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Gibbs</LastName><ForeName>Emma</ForeName><Initials>E</Initials><Identifier Source="ORCID">http://orcid.org/0000-0002-7199-9486</Identifier><AffiliationInfo><Affiliation>NHMRC Clinical Trials Centre, University of Sydney, Camperdown, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Gandhi</LastName><ForeName>Mihir</ForeName><Initials>M</Initials><Identifier Source="ORCID">http://orcid.org/0000-0002-8902-2710</Identifier><AffiliationInfo><Affiliation>Biostatistics, Singapore Clinical Research Institute, Singapore, Singapore.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Chatellier</LastName><ForeName>Gilles</ForeName><Initials>G</Initials><Identifier Source="ORCID">http://orcid.org/0000-0002-6373-8956</Identifier><AffiliationInfo><Affiliation>Clinical Research Unit, Assistance Publique, Hôpitaux de Paris, Paris, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Dinut</LastName><ForeName>Aurelia</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Clinical Research Unit, Assistance Publique, Hôpitaux de Paris, Paris, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Pereira</LastName><ForeName>Helena</ForeName><Initials>H</Initials><AffiliationInfo><Affiliation>Clinical Research Unit, Assistance Publique, Hôpitaux de Paris, Paris, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Chow</LastName><ForeName>Pierce Kh</ForeName><Initials>PK</Initials><Identifier Source="ORCID">http://orcid.org/0000-0003-0584-2584</Identifier><AffiliationInfo><Affiliation>Division of Surgical Oncology, National Cancer Centre Singapore, Singapore, Singapore.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Vilgrain</LastName><ForeName>Valérie</ForeName><Initials>V</Initials><AffiliationInfo><Affiliation>Department of Radiology, Assistance Publique, Hôpitaux de Paris, Paris, France.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2017</Year><Month>02</Month><Day>15</Day></ArticleDate></Article><MedlineJournalInfo><Country>Canada</Country><MedlineTA>JMIR Res Protoc</MedlineTA><NlmUniqueID>101599504</NlmUniqueID><ISSNLinking>1929-0748</ISSNLinking></MedlineJournalInfo><CommentsCorrectionsList><CommentsCorrections RefType="Cites"><RefSource>Hepatology. 2008 Jan;47(1):71-81</RefSource><PMID Version="1">18027884</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>PLoS One. 2016 May 05;11(5):e0154986</RefSource><PMID Version="1">27149067</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Hepatology. 2011 Sep 2;54(3):868-78</RefSource><PMID Version="1">21618574</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Contemp Clin Trials. 2010 Jan;31(1):55-61</RefSource><PMID Version="1">19737631</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Br J Cancer. 1994 Nov;70(5):994-9</RefSource><PMID 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RefType="Cites"><RefSource>CA Cancer J Clin. 2015 Mar;65(2):87-108</RefSource><PMID Version="1">25651787</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Lancet Oncol. 2009 Jan;10(1):25-34</RefSource><PMID Version="1">19095497</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>J Hepatol. 2006 Oct;45(4):529-38</RefSource><PMID Version="1">16879891</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>J Vasc Interv Radiol. 2007 Nov;18(11):1375-82</RefSource><PMID Version="1">18003987</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Eur J Cancer. 2012 Jul;48(10):1452-65</RefSource><PMID Version="1">22240282</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Oncologist. 2014 Apr;19(4):394-402</RefSource><PMID Version="1">24652387</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Int J Radiat Oncol Biol Phys. 2006 Nov 1;66(3):792-800</RefSource><PMID Version="1">16904840</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>BMC Cancer. 2016 Nov 7;16(1):856</RefSource><PMID Version="1">27821083</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>J Natl Cancer Inst. 2008 May 21;100(10):698-711</RefSource><PMID Version="1">18477802</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Liver Int. 2016 Aug;36(8):1206-12</RefSource><PMID Version="1">26910784</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>J Hepatol. 2012 Apr;56(4):908-43</RefSource><PMID Version="1">22424438</PMID></CommentsCorrections></CommentsCorrectionsList><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">advanced hepatocellular carcinoma</Keyword><Keyword MajorTopicYN="N">individual patient data prospective meta-analysis</Keyword><Keyword MajorTopicYN="N">noninferiority</Keyword><Keyword MajorTopicYN="N">percentage of active control retained</Keyword><Keyword MajorTopicYN="N">selective internal radiation therapy</Keyword><Keyword MajorTopicYN="N">sorafenib</Keyword></KeywordList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2016</Year><Month>11</Month><Day>17</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2017</Year><Month>01</Month><Day>08</Day></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2017</Year><Month>2</Month><Day>17</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2017</Year><Month>2</Month><Day>17</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2017</Year><Month>2</Month><Day>17</Day><Hour>6</Hour><Minute>1</Minute></PubMedPubDate></History><PublicationStatus>epublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">28202430</ArticleId><ArticleId IdType="pii">v6i2e17</ArticleId><ArticleId IdType="doi">10.2196/resprot.7016</ArticleId><ArticleId 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