Objective response by mRECIST as a predictor and potential surrogate end point of overall survival in advanced HCC

Background & Aims: The Modified Response Evaluation Criteria in Solid Tumors (mRECIST) was developed to overcome the limitations of standard RECIST criteria in response assessment of hepatocellular carcinoma (HCC). We aimed to investigate whether objective response by mRECIST accurately predicte...

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Autores: Lencioni, Riccardo, Montal, Robert, Torre, Ferran, Park, Joong-Won, Decaens, Thomas, Raoul, Jean-Luc, Kudo, Masatoshi, Chang, Charissa Y., Ríos, José, Boige, Valerie, Assenat, Eric, Kang, Yoon-Koo, Lim, Ho-Yeong, Walters, Ian, Llovet i Bayer, Josep Maria
Tipo de recurso: artículo
Estado:Versión aceptada para publicación
Fecha de publicación:2017
País:España
Institución:Universidad de Barcelona
Repositorio:Dipòsit Digital de la UB
OAI Identifier:oai:diposit.ub.edu:2445/120389
Acceso en línea:https://hdl.handle.net/2445/120389
Access Level:acceso abierto
Palabra clave:Càncer de fetge
Assaigs clínics
Pronòstic mèdic
Liver cancer
Clinical trials
Prognosis
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spelling Objective response by mRECIST as a predictor and potential surrogate end point of overall survival in advanced HCCLencioni, RiccardoMontal, RobertTorre, FerranPark, Joong-WonDecaens, ThomasRaoul, Jean-LucKudo, MasatoshiChang, Charissa Y.Ríos, JoséBoige, ValerieAssenat, EricKang, Yoon-KooLim, Ho-YeongWalters, IanLlovet i Bayer, Josep MariaCàncer de fetgeAssaigs clínicsPronòstic mèdicLiver cancerClinical trialsPrognosisBackground & Aims: The Modified Response Evaluation Criteria in Solid Tumors (mRECIST) was developed to overcome the limitations of standard RECIST criteria in response assessment of hepatocellular carcinoma (HCC). We aimed to investigate whether objective response by mRECIST accurately predicted overall survival (OS) in patients with advanced HCC treated with systemic targeted therapies and also to preliminarily assess this endpoint as a potential surrogate of OS.Methods: Individual patient data from the BRISK-PS randomized phase III trial comparing brivanib vs. placebo (the first to prospectively incorporate mRECIST) were used to analyze objective response as a predictor of OS in a time-dependent covariate analysis. Patients with available imaging scans during follow-up were included (n = 334; 85% of those randomized). Moreover, a correlation of the survival probability in deciles vs. the observed objective response was performed to evaluate its suitability as a surrogate end-point.Results: Objective response was observed in 11.5% and 1.9% of patients treated with brivanib and placebo respectively, and was associated with a better survival (median OS 15.0 vs. 9.4 months, p < 0.001). In addition, objective response had an independent prognostic value (HR = 0.48; 95% confidence interval [CI], 0.26-0.91, p = 0.025) along with known prognostic factors. Finally, objective response showed promising results as a surrogate of OS in this trial (R = -0.92; 95% CI, -1 to -0.73, p < 0.001). It was an early indicator of the treatment effect (median time to objective response was 1.4 months).Conclusions: Objective response by mRECIST in advanced HCC predicts OS and thus can be considered as a candidate surrogate end-point. Further studies are needed to support this finding.Lay summary: There is a need to identify surrogate end-points for overall survival in advanced hepatocellular carcinoma. We studied patients from the phase III BRISK trial, comparing brivanib treatment with placebo after sorafenib progression. We demonstrate that objective response is an independent predictor of survival and qualifies as a potential surrogate end-point for overall survival in this patient population.Clinical trial number: NCT00825955.Elsevier2017info:eu-repo/semantics/articleinfo:eu-repo/semantics/acceptedVersionapplication/pdfhttps://hdl.handle.net/2445/120389Articles publicats en revistes (Medicina)reponame:Dipòsit Digital de la UBinstname:Universidad de BarcelonaInglésVersió postprint del document publicat a: https://doi.org/10.1016/j.jhep.2017.01.012Journal of Hepatology, 2017, vol. 66, num. 6, p. 1166-1172https://doi.org/10.1016/j.jhep.2017.01.012info:eu-repo/grantAgreement/EC/H2020/667273cc-by-nc-nd (c) Elsevier, 2017http://creativecommons.org/licenses/by-nc-nd/3.0/esinfo:eu-repo/semantics/openAccessoai:diposit.ub.edu:2445/1203892026-05-27T06:46:51Z
dc.title.none.fl_str_mv Objective response by mRECIST as a predictor and potential surrogate end point of overall survival in advanced HCC
title Objective response by mRECIST as a predictor and potential surrogate end point of overall survival in advanced HCC
spellingShingle Objective response by mRECIST as a predictor and potential surrogate end point of overall survival in advanced HCC
Lencioni, Riccardo
Càncer de fetge
Assaigs clínics
Pronòstic mèdic
Liver cancer
Clinical trials
Prognosis
title_short Objective response by mRECIST as a predictor and potential surrogate end point of overall survival in advanced HCC
title_full Objective response by mRECIST as a predictor and potential surrogate end point of overall survival in advanced HCC
title_fullStr Objective response by mRECIST as a predictor and potential surrogate end point of overall survival in advanced HCC
title_full_unstemmed Objective response by mRECIST as a predictor and potential surrogate end point of overall survival in advanced HCC
title_sort Objective response by mRECIST as a predictor and potential surrogate end point of overall survival in advanced HCC
dc.creator.none.fl_str_mv Lencioni, Riccardo
Montal, Robert
Torre, Ferran
Park, Joong-Won
Decaens, Thomas
Raoul, Jean-Luc
Kudo, Masatoshi
Chang, Charissa Y.
Ríos, José
Boige, Valerie
Assenat, Eric
Kang, Yoon-Koo
Lim, Ho-Yeong
Walters, Ian
Llovet i Bayer, Josep Maria
author Lencioni, Riccardo
author_facet Lencioni, Riccardo
Montal, Robert
Torre, Ferran
Park, Joong-Won
Decaens, Thomas
Raoul, Jean-Luc
Kudo, Masatoshi
Chang, Charissa Y.
Ríos, José
Boige, Valerie
Assenat, Eric
Kang, Yoon-Koo
Lim, Ho-Yeong
Walters, Ian
Llovet i Bayer, Josep Maria
author_role author
author2 Montal, Robert
Torre, Ferran
Park, Joong-Won
Decaens, Thomas
Raoul, Jean-Luc
Kudo, Masatoshi
Chang, Charissa Y.
Ríos, José
Boige, Valerie
Assenat, Eric
Kang, Yoon-Koo
Lim, Ho-Yeong
Walters, Ian
Llovet i Bayer, Josep Maria
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv Càncer de fetge
Assaigs clínics
Pronòstic mèdic
Liver cancer
Clinical trials
Prognosis
topic Càncer de fetge
Assaigs clínics
Pronòstic mèdic
Liver cancer
Clinical trials
Prognosis
description Background & Aims: The Modified Response Evaluation Criteria in Solid Tumors (mRECIST) was developed to overcome the limitations of standard RECIST criteria in response assessment of hepatocellular carcinoma (HCC). We aimed to investigate whether objective response by mRECIST accurately predicted overall survival (OS) in patients with advanced HCC treated with systemic targeted therapies and also to preliminarily assess this endpoint as a potential surrogate of OS.Methods: Individual patient data from the BRISK-PS randomized phase III trial comparing brivanib vs. placebo (the first to prospectively incorporate mRECIST) were used to analyze objective response as a predictor of OS in a time-dependent covariate analysis. Patients with available imaging scans during follow-up were included (n = 334; 85% of those randomized). Moreover, a correlation of the survival probability in deciles vs. the observed objective response was performed to evaluate its suitability as a surrogate end-point.Results: Objective response was observed in 11.5% and 1.9% of patients treated with brivanib and placebo respectively, and was associated with a better survival (median OS 15.0 vs. 9.4 months, p < 0.001). In addition, objective response had an independent prognostic value (HR = 0.48; 95% confidence interval [CI], 0.26-0.91, p = 0.025) along with known prognostic factors. Finally, objective response showed promising results as a surrogate of OS in this trial (R = -0.92; 95% CI, -1 to -0.73, p < 0.001). It was an early indicator of the treatment effect (median time to objective response was 1.4 months).Conclusions: Objective response by mRECIST in advanced HCC predicts OS and thus can be considered as a candidate surrogate end-point. Further studies are needed to support this finding.Lay summary: There is a need to identify surrogate end-points for overall survival in advanced hepatocellular carcinoma. We studied patients from the phase III BRISK trial, comparing brivanib treatment with placebo after sorafenib progression. We demonstrate that objective response is an independent predictor of survival and qualifies as a potential surrogate end-point for overall survival in this patient population.Clinical trial number: NCT00825955.
publishDate 2017
dc.date.none.fl_str_mv 2017
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/acceptedVersion
format article
status_str acceptedVersion
dc.identifier.none.fl_str_mv https://hdl.handle.net/2445/120389
url https://hdl.handle.net/2445/120389
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.relation.none.fl_str_mv Versió postprint del document publicat a: https://doi.org/10.1016/j.jhep.2017.01.012
Journal of Hepatology, 2017, vol. 66, num. 6, p. 1166-1172
https://doi.org/10.1016/j.jhep.2017.01.012
info:eu-repo/grantAgreement/EC/H2020/667273
dc.rights.none.fl_str_mv cc-by-nc-nd (c) Elsevier, 2017
http://creativecommons.org/licenses/by-nc-nd/3.0/es
info:eu-repo/semantics/openAccess
rights_invalid_str_mv cc-by-nc-nd (c) Elsevier, 2017
http://creativecommons.org/licenses/by-nc-nd/3.0/es
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv Elsevier
publisher.none.fl_str_mv Elsevier
dc.source.none.fl_str_mv Articles publicats en revistes (Medicina)
reponame:Dipòsit Digital de la UB
instname:Universidad de Barcelona
instname_str Universidad de Barcelona
reponame_str Dipòsit Digital de la UB
collection Dipòsit Digital de la UB
repository.name.fl_str_mv
repository.mail.fl_str_mv
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score 15,300719

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