Surrogate endpoints in phase III randomized trials of advanced gastroesophageal cancer: A systematic review and meta-analysis

Overall survival (OS) is the most meaningful endpoint in clinical trials. However, owing to their limitations, surrogate endpoints are commonly used and validation studies are required to assess their reliability. Analysis of phase III randomized controlled trials (RCTs) of advanced gastroesophageal...

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Autores: Veas Rodríguez, Joel, Prieto, Ana, Vilaprinyo Terré, Ester, Bonet, Marta, Diez, Marc, Salud Salvia, Maria Antonieta, Montal Roura, Robert
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2024
País:España
Institución:Universitat de Lleida (UdL)
Repositorio:Repositori Obert UdL
OAI Identifier:oai:repositori.udl.cat:10459.1/467070
Acceso en línea:https://doi.org/10.1016/j.critrevonc.2024.104416
https://hdl.handle.net/10459.1/467070
Access Level:acceso abierto
Palabra clave:Surrogate endpoints
Gastroesophageal cancer
Phase III randomized controlled trials
Correlation analysis
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spelling Surrogate endpoints in phase III randomized trials of advanced gastroesophageal cancer: A systematic review and meta-analysisVeas Rodríguez, JoelPrieto, AnaVilaprinyo Terré, EsterBonet, MartaDiez, MarcSalud Salvia, Maria AntonietaMontal Roura, RobertSurrogate endpointsGastroesophageal cancerPhase III randomized controlled trialsCorrelation analysisOverall survival (OS) is the most meaningful endpoint in clinical trials. However, owing to their limitations, surrogate endpoints are commonly used and validation studies are required to assess their reliability. Analysis of phase III randomized controlled trials (RCTs) of advanced gastroesophageal cancer (AGC) with > 100 patients, correlation coefficients (r), and determination coefficients (R²) between OS and surrogates were evaluated through meta-analyses. Progression-free survival (PFS), time to progression (TTP), and objective response rate (ORR) were examined to determine their correlations with OS. Analysis of 65 phase III RCTs (29,766 subjects) showed a moderate correlation between PFS/TTP and OS (r = 0.77, R² = 0.59), while ORR correlation was low (r = 0.56, R² = 0.31). Excluding immunotherapy trials improved the PFS/TTP and OS correlations (r = 0.83, R² = 0.70). These findings suggest the potential use of PFS/TTP in AGC phase III investigations, disregarding the use of ORR as a surrogate endpoint.E.V. acknowledges the support from ISCIII (PI20/00377); R.M. ac knowledges the support from ISCIII (PI21/01619 research project and Juan Rod´es contract), SEOM (research project), TTD (research project) and Fundacion ´ MERCK Salud (research project).Elsevier2024info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttps://doi.org/10.1016/j.critrevonc.2024.104416https://hdl.handle.net/10459.1/467070reponame:Repositori Obert UdL instname:Universitat de Lleida (UdL)InglésReproducció del document publicat a https://doi.org/10.1016/j.critrevonc.2024.104416Critical Reviews in Oncology/Hematology, 2024, vol. 201, 104416cc-by-nc (c) Joel Veas Rodríguez et al., 2024Attribution-NonCommercial 4.0 Internationalinfo:eu-repo/semantics/openAccesshttp://creativecommons.org/licenses/by-nc/4.0/oai:repositori.udl.cat:10459.1/4670702026-06-24T12:42:17Z
dc.title.none.fl_str_mv Surrogate endpoints in phase III randomized trials of advanced gastroesophageal cancer: A systematic review and meta-analysis
title Surrogate endpoints in phase III randomized trials of advanced gastroesophageal cancer: A systematic review and meta-analysis
spellingShingle Surrogate endpoints in phase III randomized trials of advanced gastroesophageal cancer: A systematic review and meta-analysis
Veas Rodríguez, Joel
Surrogate endpoints
Gastroesophageal cancer
Phase III randomized controlled trials
Correlation analysis
title_short Surrogate endpoints in phase III randomized trials of advanced gastroesophageal cancer: A systematic review and meta-analysis
title_full Surrogate endpoints in phase III randomized trials of advanced gastroesophageal cancer: A systematic review and meta-analysis
title_fullStr Surrogate endpoints in phase III randomized trials of advanced gastroesophageal cancer: A systematic review and meta-analysis
title_full_unstemmed Surrogate endpoints in phase III randomized trials of advanced gastroesophageal cancer: A systematic review and meta-analysis
title_sort Surrogate endpoints in phase III randomized trials of advanced gastroesophageal cancer: A systematic review and meta-analysis
dc.creator.none.fl_str_mv Veas Rodríguez, Joel
Prieto, Ana
Vilaprinyo Terré, Ester
Bonet, Marta
Diez, Marc
Salud Salvia, Maria Antonieta
Montal Roura, Robert
author Veas Rodríguez, Joel
author_facet Veas Rodríguez, Joel
Prieto, Ana
Vilaprinyo Terré, Ester
Bonet, Marta
Diez, Marc
Salud Salvia, Maria Antonieta
Montal Roura, Robert
author_role author
author2 Prieto, Ana
Vilaprinyo Terré, Ester
Bonet, Marta
Diez, Marc
Salud Salvia, Maria Antonieta
Montal Roura, Robert
author2_role author
author
author
author
author
author
dc.subject.none.fl_str_mv Surrogate endpoints
Gastroesophageal cancer
Phase III randomized controlled trials
Correlation analysis
topic Surrogate endpoints
Gastroesophageal cancer
Phase III randomized controlled trials
Correlation analysis
description Overall survival (OS) is the most meaningful endpoint in clinical trials. However, owing to their limitations, surrogate endpoints are commonly used and validation studies are required to assess their reliability. Analysis of phase III randomized controlled trials (RCTs) of advanced gastroesophageal cancer (AGC) with > 100 patients, correlation coefficients (r), and determination coefficients (R²) between OS and surrogates were evaluated through meta-analyses. Progression-free survival (PFS), time to progression (TTP), and objective response rate (ORR) were examined to determine their correlations with OS. Analysis of 65 phase III RCTs (29,766 subjects) showed a moderate correlation between PFS/TTP and OS (r = 0.77, R² = 0.59), while ORR correlation was low (r = 0.56, R² = 0.31). Excluding immunotherapy trials improved the PFS/TTP and OS correlations (r = 0.83, R² = 0.70). These findings suggest the potential use of PFS/TTP in AGC phase III investigations, disregarding the use of ORR as a surrogate endpoint.
publishDate 2024
dc.date.none.fl_str_mv 2024
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv https://doi.org/10.1016/j.critrevonc.2024.104416
https://hdl.handle.net/10459.1/467070
url https://doi.org/10.1016/j.critrevonc.2024.104416
https://hdl.handle.net/10459.1/467070
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.relation.none.fl_str_mv Reproducció del document publicat a https://doi.org/10.1016/j.critrevonc.2024.104416
Critical Reviews in Oncology/Hematology, 2024, vol. 201, 104416
dc.rights.none.fl_str_mv cc-by-nc (c) Joel Veas Rodríguez et al., 2024
Attribution-NonCommercial 4.0 International
info:eu-repo/semantics/openAccess
http://creativecommons.org/licenses/by-nc/4.0/
rights_invalid_str_mv cc-by-nc (c) Joel Veas Rodríguez et al., 2024
Attribution-NonCommercial 4.0 International
http://creativecommons.org/licenses/by-nc/4.0/
eu_rights_str_mv openAccess
dc.publisher.none.fl_str_mv Elsevier
publisher.none.fl_str_mv Elsevier
dc.source.none.fl_str_mv reponame:Repositori Obert UdL
instname:Universitat de Lleida (UdL)
instname_str Universitat de Lleida (UdL)
reponame_str Repositori Obert UdL
collection Repositori Obert UdL
repository.name.fl_str_mv
repository.mail.fl_str_mv
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