Surrogate endpoints in advanced sarcoma trials: a meta-analysis
Alternative endpoints to overall survival (OS) are frequently used to assess treatment efficacy in randomized controlled trials (RCT). Their properties in terms of surrogate outcomes for OS need to be assessed. We evaluated the surrogate properties of progression-free survival (PFS), time-to-progres...
Gespeichert in:
| Veröffentlicht in: | Oncotarget 2018-10, Vol.9 (77), p.34617-34627 |
|---|---|
| Hauptverfasser: | , , , , , , , , , , , , , , , , , , , |
| Format: | Artikel |
| Sprache: | eng |
| Schlagworte: | |
| Online-Zugang: | Volltext |
| Tags: |
Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
|
| container_end_page | 34627 |
|---|---|
| container_issue | 77 |
| container_start_page | 34617 |
| container_title | Oncotarget |
| container_volume | 9 |
| creator | Savina, Marion Litière, Saskia Italiano, Antoine Burzykowski, Tomasz Bonnetain, Franck Gourgou, Sophie Rondeau, Virginie Blay, Jean-Yves Cousin, Sophie Duffaud, Florence Gelderblom, Hans Gronchi, Alessandro Judson, Ian Le Cesne, Axel Lorigan, Paul Maurel, Joan van der Graaf, Winette Verweij, Jaap Mathoulin-Pélissier, Simone Bellera, Carine |
| description | Alternative endpoints to overall survival (OS) are frequently used to assess treatment efficacy in randomized controlled trials (RCT). Their properties in terms of surrogate outcomes for OS need to be assessed. We evaluated the surrogate properties of progression-free survival (PFS), time-to-progression (TTP) and time-to-treatment failure (TTF) in advanced soft tissue sarcomas (STS).
A total of 21 trials originally met the selection criteria and 14 RCTs (
= 2846) were included in the analysis. Individual-level associations were moderate (highest for 12-month PFS: Spearman's rho = 0.66; 95% CI [0.63; 0.68]). Trial-level associations were ranked as low for the three endpoints as per the IQWiG criterion.
We performed a meta-analysis using individual-patient data (IPD). Phase II/III RCTs evaluating therapies for adults with advanced STS were eligible. We estimated the individual- and the trial-level associations between then candidate surrogates and OS. Statistical methods included weighted linear regression and the two-stage model introduced by Buyse and Burzykowski. The strength of the trial-level association was ranked according to the German Institute for Quality and Efficiency in Health Care (IQWiG) guidelines.
Our results do not support strong surrogate properties of PFS, TTP and TTF for OS in advanced STS. |
| doi_str_mv | 10.18632/oncotarget.26166 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_6195375</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2126904655</sourcerecordid><originalsourceid>FETCH-LOGICAL-c371t-e9fd7f6558dc70015aa0c3349b2a84079ef79de4e9a65a8a42abe3ae9f7f82aa3</originalsourceid><addsrcrecordid>eNpdUU1PGzEQtSpQiYAf0AvaIxwW_LH2rjkUoahApUg9tD1bE-9sWLRrp7YTKf8eN0khdC4zmnnvzYweIV8YvWaNEvzGO-sThAWma66YUp_IhOlKl1xKcXRQn5DzGF9oDlnVDdefyYmgotJKigm5-7kKwS8gYYGuXfrepVj0roB2Dc5iW0QI1o9QpNDDEG8LKEZMUIKDYRP7eEaOu9zH830-Jb8fvv2aPpWzH4_fp_ez0oqapRJ119adkrJpbU0pkwDUinzEnENT0VpjV-sWK9SgJDRQcZijgEyru4YDiFPydae7XM1HbC26FGAwy9CPEDbGQ28-Tlz_bBZ-bRTTUtQyC1ztBJ7_oz3dz8zfHhVMyUroNcvYy_2y4P-sMCYz9tHiMIBDv4qGM640rfI7Gcp2UBt8jAG7N21GzdYn8-6T2fqUOReHv7wx_rkiXgFgBJIQ</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2126904655</pqid></control><display><type>article</type><title>Surrogate endpoints in advanced sarcoma trials: a meta-analysis</title><source>Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals</source><source>PubMed Central</source><source>Free E- Journals</source><source>PubMed Central Open Access</source><creator>Savina, Marion ; Litière, Saskia ; Italiano, Antoine ; Burzykowski, Tomasz ; Bonnetain, Franck ; Gourgou, Sophie ; Rondeau, Virginie ; Blay, Jean-Yves ; Cousin, Sophie ; Duffaud, Florence ; Gelderblom, Hans ; Gronchi, Alessandro ; Judson, Ian ; Le Cesne, Axel ; Lorigan, Paul ; Maurel, Joan ; van der Graaf, Winette ; Verweij, Jaap ; Mathoulin-Pélissier, Simone ; Bellera, Carine</creator><creatorcontrib>Savina, Marion ; Litière, Saskia ; Italiano, Antoine ; Burzykowski, Tomasz ; Bonnetain, Franck ; Gourgou, Sophie ; Rondeau, Virginie ; Blay, Jean-Yves ; Cousin, Sophie ; Duffaud, Florence ; Gelderblom, Hans ; Gronchi, Alessandro ; Judson, Ian ; Le Cesne, Axel ; Lorigan, Paul ; Maurel, Joan ; van der Graaf, Winette ; Verweij, Jaap ; Mathoulin-Pélissier, Simone ; Bellera, Carine</creatorcontrib><description>Alternative endpoints to overall survival (OS) are frequently used to assess treatment efficacy in randomized controlled trials (RCT). Their properties in terms of surrogate outcomes for OS need to be assessed. We evaluated the surrogate properties of progression-free survival (PFS), time-to-progression (TTP) and time-to-treatment failure (TTF) in advanced soft tissue sarcomas (STS).
A total of 21 trials originally met the selection criteria and 14 RCTs (
= 2846) were included in the analysis. Individual-level associations were moderate (highest for 12-month PFS: Spearman's rho = 0.66; 95% CI [0.63; 0.68]). Trial-level associations were ranked as low for the three endpoints as per the IQWiG criterion.
We performed a meta-analysis using individual-patient data (IPD). Phase II/III RCTs evaluating therapies for adults with advanced STS were eligible. We estimated the individual- and the trial-level associations between then candidate surrogates and OS. Statistical methods included weighted linear regression and the two-stage model introduced by Buyse and Burzykowski. The strength of the trial-level association was ranked according to the German Institute for Quality and Efficiency in Health Care (IQWiG) guidelines.
Our results do not support strong surrogate properties of PFS, TTP and TTF for OS in advanced STS.</description><identifier>ISSN: 1949-2553</identifier><identifier>EISSN: 1949-2553</identifier><identifier>DOI: 10.18632/oncotarget.26166</identifier><identifier>PMID: 30349653</identifier><language>eng</language><publisher>United States: Impact journals</publisher><subject>Cancer ; Life Sciences ; Meta-Analysis ; Santé publique et épidémiologie</subject><ispartof>Oncotarget, 2018-10, Vol.9 (77), p.34617-34627</ispartof><rights>Attribution</rights><rights>Copyright: © 2018 Savina et al. 2018</rights><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c371t-e9fd7f6558dc70015aa0c3349b2a84079ef79de4e9a65a8a42abe3ae9f7f82aa3</citedby><cites>FETCH-LOGICAL-c371t-e9fd7f6558dc70015aa0c3349b2a84079ef79de4e9a65a8a42abe3ae9f7f82aa3</cites><orcidid>0000-0001-7926-4671</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC6195375/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC6195375/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,723,776,780,881,27902,27903,53768,53770</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/30349653$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink><backlink>$$Uhttps://hal.science/hal-03165439$$DView record in HAL$$Hfree_for_read</backlink></links><search><creatorcontrib>Savina, Marion</creatorcontrib><creatorcontrib>Litière, Saskia</creatorcontrib><creatorcontrib>Italiano, Antoine</creatorcontrib><creatorcontrib>Burzykowski, Tomasz</creatorcontrib><creatorcontrib>Bonnetain, Franck</creatorcontrib><creatorcontrib>Gourgou, Sophie</creatorcontrib><creatorcontrib>Rondeau, Virginie</creatorcontrib><creatorcontrib>Blay, Jean-Yves</creatorcontrib><creatorcontrib>Cousin, Sophie</creatorcontrib><creatorcontrib>Duffaud, Florence</creatorcontrib><creatorcontrib>Gelderblom, Hans</creatorcontrib><creatorcontrib>Gronchi, Alessandro</creatorcontrib><creatorcontrib>Judson, Ian</creatorcontrib><creatorcontrib>Le Cesne, Axel</creatorcontrib><creatorcontrib>Lorigan, Paul</creatorcontrib><creatorcontrib>Maurel, Joan</creatorcontrib><creatorcontrib>van der Graaf, Winette</creatorcontrib><creatorcontrib>Verweij, Jaap</creatorcontrib><creatorcontrib>Mathoulin-Pélissier, Simone</creatorcontrib><creatorcontrib>Bellera, Carine</creatorcontrib><title>Surrogate endpoints in advanced sarcoma trials: a meta-analysis</title><title>Oncotarget</title><addtitle>Oncotarget</addtitle><description>Alternative endpoints to overall survival (OS) are frequently used to assess treatment efficacy in randomized controlled trials (RCT). Their properties in terms of surrogate outcomes for OS need to be assessed. We evaluated the surrogate properties of progression-free survival (PFS), time-to-progression (TTP) and time-to-treatment failure (TTF) in advanced soft tissue sarcomas (STS).
A total of 21 trials originally met the selection criteria and 14 RCTs (
= 2846) were included in the analysis. Individual-level associations were moderate (highest for 12-month PFS: Spearman's rho = 0.66; 95% CI [0.63; 0.68]). Trial-level associations were ranked as low for the three endpoints as per the IQWiG criterion.
We performed a meta-analysis using individual-patient data (IPD). Phase II/III RCTs evaluating therapies for adults with advanced STS were eligible. We estimated the individual- and the trial-level associations between then candidate surrogates and OS. Statistical methods included weighted linear regression and the two-stage model introduced by Buyse and Burzykowski. The strength of the trial-level association was ranked according to the German Institute for Quality and Efficiency in Health Care (IQWiG) guidelines.
Our results do not support strong surrogate properties of PFS, TTP and TTF for OS in advanced STS.</description><subject>Cancer</subject><subject>Life Sciences</subject><subject>Meta-Analysis</subject><subject>Santé publique et épidémiologie</subject><issn>1949-2553</issn><issn>1949-2553</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2018</creationdate><recordtype>article</recordtype><recordid>eNpdUU1PGzEQtSpQiYAf0AvaIxwW_LH2rjkUoahApUg9tD1bE-9sWLRrp7YTKf8eN0khdC4zmnnvzYweIV8YvWaNEvzGO-sThAWma66YUp_IhOlKl1xKcXRQn5DzGF9oDlnVDdefyYmgotJKigm5-7kKwS8gYYGuXfrepVj0roB2Dc5iW0QI1o9QpNDDEG8LKEZMUIKDYRP7eEaOu9zH830-Jb8fvv2aPpWzH4_fp_ez0oqapRJ119adkrJpbU0pkwDUinzEnENT0VpjV-sWK9SgJDRQcZijgEyru4YDiFPydae7XM1HbC26FGAwy9CPEDbGQ28-Tlz_bBZ-bRTTUtQyC1ztBJ7_oz3dz8zfHhVMyUroNcvYy_2y4P-sMCYz9tHiMIBDv4qGM640rfI7Gcp2UBt8jAG7N21GzdYn8-6T2fqUOReHv7wx_rkiXgFgBJIQ</recordid><startdate>20181002</startdate><enddate>20181002</enddate><creator>Savina, Marion</creator><creator>Litière, Saskia</creator><creator>Italiano, Antoine</creator><creator>Burzykowski, Tomasz</creator><creator>Bonnetain, Franck</creator><creator>Gourgou, Sophie</creator><creator>Rondeau, Virginie</creator><creator>Blay, Jean-Yves</creator><creator>Cousin, Sophie</creator><creator>Duffaud, Florence</creator><creator>Gelderblom, Hans</creator><creator>Gronchi, Alessandro</creator><creator>Judson, Ian</creator><creator>Le Cesne, Axel</creator><creator>Lorigan, Paul</creator><creator>Maurel, Joan</creator><creator>van der Graaf, Winette</creator><creator>Verweij, Jaap</creator><creator>Mathoulin-Pélissier, Simone</creator><creator>Bellera, Carine</creator><general>Impact journals</general><general>Impact Journals LLC</general><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><scope>1XC</scope><scope>VOOES</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0001-7926-4671</orcidid></search><sort><creationdate>20181002</creationdate><title>Surrogate endpoints in advanced sarcoma trials: a meta-analysis</title><author>Savina, Marion ; Litière, Saskia ; Italiano, Antoine ; Burzykowski, Tomasz ; Bonnetain, Franck ; Gourgou, Sophie ; Rondeau, Virginie ; Blay, Jean-Yves ; Cousin, Sophie ; Duffaud, Florence ; Gelderblom, Hans ; Gronchi, Alessandro ; Judson, Ian ; Le Cesne, Axel ; Lorigan, Paul ; Maurel, Joan ; van der Graaf, Winette ; Verweij, Jaap ; Mathoulin-Pélissier, Simone ; Bellera, Carine</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c371t-e9fd7f6558dc70015aa0c3349b2a84079ef79de4e9a65a8a42abe3ae9f7f82aa3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2018</creationdate><topic>Cancer</topic><topic>Life Sciences</topic><topic>Meta-Analysis</topic><topic>Santé publique et épidémiologie</topic><toplevel>online_resources</toplevel><creatorcontrib>Savina, Marion</creatorcontrib><creatorcontrib>Litière, Saskia</creatorcontrib><creatorcontrib>Italiano, Antoine</creatorcontrib><creatorcontrib>Burzykowski, Tomasz</creatorcontrib><creatorcontrib>Bonnetain, Franck</creatorcontrib><creatorcontrib>Gourgou, Sophie</creatorcontrib><creatorcontrib>Rondeau, Virginie</creatorcontrib><creatorcontrib>Blay, Jean-Yves</creatorcontrib><creatorcontrib>Cousin, Sophie</creatorcontrib><creatorcontrib>Duffaud, Florence</creatorcontrib><creatorcontrib>Gelderblom, Hans</creatorcontrib><creatorcontrib>Gronchi, Alessandro</creatorcontrib><creatorcontrib>Judson, Ian</creatorcontrib><creatorcontrib>Le Cesne, Axel</creatorcontrib><creatorcontrib>Lorigan, Paul</creatorcontrib><creatorcontrib>Maurel, Joan</creatorcontrib><creatorcontrib>van der Graaf, Winette</creatorcontrib><creatorcontrib>Verweij, Jaap</creatorcontrib><creatorcontrib>Mathoulin-Pélissier, Simone</creatorcontrib><creatorcontrib>Bellera, Carine</creatorcontrib><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>Hyper Article en Ligne (HAL)</collection><collection>Hyper Article en Ligne (HAL) (Open Access)</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Oncotarget</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Savina, Marion</au><au>Litière, Saskia</au><au>Italiano, Antoine</au><au>Burzykowski, Tomasz</au><au>Bonnetain, Franck</au><au>Gourgou, Sophie</au><au>Rondeau, Virginie</au><au>Blay, Jean-Yves</au><au>Cousin, Sophie</au><au>Duffaud, Florence</au><au>Gelderblom, Hans</au><au>Gronchi, Alessandro</au><au>Judson, Ian</au><au>Le Cesne, Axel</au><au>Lorigan, Paul</au><au>Maurel, Joan</au><au>van der Graaf, Winette</au><au>Verweij, Jaap</au><au>Mathoulin-Pélissier, Simone</au><au>Bellera, Carine</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Surrogate endpoints in advanced sarcoma trials: a meta-analysis</atitle><jtitle>Oncotarget</jtitle><addtitle>Oncotarget</addtitle><date>2018-10-02</date><risdate>2018</risdate><volume>9</volume><issue>77</issue><spage>34617</spage><epage>34627</epage><pages>34617-34627</pages><issn>1949-2553</issn><eissn>1949-2553</eissn><abstract>Alternative endpoints to overall survival (OS) are frequently used to assess treatment efficacy in randomized controlled trials (RCT). Their properties in terms of surrogate outcomes for OS need to be assessed. We evaluated the surrogate properties of progression-free survival (PFS), time-to-progression (TTP) and time-to-treatment failure (TTF) in advanced soft tissue sarcomas (STS).
A total of 21 trials originally met the selection criteria and 14 RCTs (
= 2846) were included in the analysis. Individual-level associations were moderate (highest for 12-month PFS: Spearman's rho = 0.66; 95% CI [0.63; 0.68]). Trial-level associations were ranked as low for the three endpoints as per the IQWiG criterion.
We performed a meta-analysis using individual-patient data (IPD). Phase II/III RCTs evaluating therapies for adults with advanced STS were eligible. We estimated the individual- and the trial-level associations between then candidate surrogates and OS. Statistical methods included weighted linear regression and the two-stage model introduced by Buyse and Burzykowski. The strength of the trial-level association was ranked according to the German Institute for Quality and Efficiency in Health Care (IQWiG) guidelines.
Our results do not support strong surrogate properties of PFS, TTP and TTF for OS in advanced STS.</abstract><cop>United States</cop><pub>Impact journals</pub><pmid>30349653</pmid><doi>10.18632/oncotarget.26166</doi><tpages>11</tpages><orcidid>https://orcid.org/0000-0001-7926-4671</orcidid><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1949-2553 |
| ispartof | Oncotarget, 2018-10, Vol.9 (77), p.34617-34627 |
| issn | 1949-2553 1949-2553 |
| language | eng |
| recordid | cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_6195375 |
| source | Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; PubMed Central; Free E- Journals; PubMed Central Open Access |
| subjects | Cancer Life Sciences Meta-Analysis Santé publique et épidémiologie |
| title | Surrogate endpoints in advanced sarcoma trials: a meta-analysis |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-01-27T08%3A30%3A02IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_pubme&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Surrogate%20endpoints%20in%20advanced%20sarcoma%20trials:%20a%20meta-analysis&rft.jtitle=Oncotarget&rft.au=Savina,%20Marion&rft.date=2018-10-02&rft.volume=9&rft.issue=77&rft.spage=34617&rft.epage=34627&rft.pages=34617-34627&rft.issn=1949-2553&rft.eissn=1949-2553&rft_id=info:doi/10.18632/oncotarget.26166&rft_dat=%3Cproquest_pubme%3E2126904655%3C/proquest_pubme%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=2126904655&rft_id=info:pmid/30349653&rfr_iscdi=true |