Ramucirumab in elderly patients with hepatocellular carcinoma and elevated alpha-fetoprotein after sorafenib in REACH and REACH-2

Background & Aims: Limited data on treatment of elderly patients with hepatocellular carcinoma (HCC) increase the unmet need. REACH and REACH‐2 were global phase III studies of ramucirumab in patients with HCC after prior sorafenib, where patients with alpha‐fetoprotein (AFP) ≥400 ng/mL showed a...

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Autores: Kudo, Masatoshi, Galle, Peter R., Llovet i Bayer, Josep Maria, Finn, Richard S., Vogel, Arndt, Motomura, Kenta, Assenat, Eric, Merle, Philippe, Brandi, Giovanni, Daniele, Bruno, Okusaka, Takuji, Tomášek, Jiří, Borg, Christophe, Dadduzio, Vincenzo, Morimoto, Manabu, Pracht, Marc, Jen, Min-Hua, Widau, Ryan C., Shinozaki, Kenta, Yoshikawa, Reigetsu, Zhu, Andrew X.
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2020
País:España
Institución:Universidad de Barcelona
Repositorio:Dipòsit Digital de la UB
OAI Identifier:oai:diposit.ub.edu:2445/173032
Acceso en línea:https://hdl.handle.net/2445/173032
Access Level:acceso abierto
Palabra clave:Càncer de fetge
Anticossos monoclonals
Persones grans dependents
Liver cancer
Monoclonal antibodies
Frail elderly
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spelling Ramucirumab in elderly patients with hepatocellular carcinoma and elevated alpha-fetoprotein after sorafenib in REACH and REACH-2Kudo, MasatoshiGalle, Peter R.Llovet i Bayer, Josep MariaFinn, Richard S.Vogel, ArndtMotomura, KentaAssenat, EricMerle, PhilippeBrandi, GiovanniDaniele, BrunoOkusaka, TakujiTomášek, JiříBorg, ChristopheDadduzio, VincenzoMorimoto, ManabuPracht, MarcJen, Min-HuaWidau, Ryan C.Shinozaki, KentaYoshikawa, ReigetsuZhu, Andrew X.Càncer de fetgeAnticossos monoclonalsPersones grans dependentsLiver cancerMonoclonal antibodiesFrail elderlyBackground & Aims: Limited data on treatment of elderly patients with hepatocellular carcinoma (HCC) increase the unmet need. REACH and REACH‐2 were global phase III studies of ramucirumab in patients with HCC after prior sorafenib, where patients with alpha‐fetoprotein (AFP) ≥400 ng/mL showed an overall ssurvival (OS) benefit for ramucirumab. These post‐hoc analyses examined efficacy and safety of ramucirumab in patients with HCC and baseline AFP ≥ 400 ng/mL by three prespecified age subgroups (<65, ≥65 to <75 and ≥75 years). Methods: Individual patient data were pooled from REACH (baseline AFP ≥400 ng/mL) and REACH‐2. Kaplan‐Meier and Cox proportional hazards regression methods (stratified by study) assessed OS, progression‐free survival (PFS), time to progression (TTP) and patient‐reported outcomes (Functional Hepatobiliary System Index‐8 [FHSI‐8] score). Results: A total of 542 patients (<65 years: n = 302; ≥65 to <75 years: n = 160; ≥75 years: n = 80) showed similar baseline characteristics between ramucirumab and placebo. Older subgroups had higher hepatitis C and steatohepatitis incidences, and lower AFP levels, than the <65 years subgroup. Ramucirumab prolonged OS in patients <65 years (hazard ratio [HR], 0.753; 95% CI 0.581‐0.975), ≥65 to <75 years (0.602; 0.419‐0.866) and ≥75 years (0.709; 0.420‐1.199), PFS and TTP irrespective of age. Ramucirumab showed similar overall safety profiles across subgroups, with a consistent median relative dose intensity ≥97.8%. A trend towards a delay in symptom deterioration in FHSI‐8 with ramucirumab was observed in all subgroups. Conclusions: In this post‐hoc analysis, ramucirumab showed a survival benefit across age subgroups with a tolerable safety profile, supporting its use in advanced HCC with elevated AFP, irrespective of age, including ≥75 years.John Wiley & Sons2020info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfhttps://hdl.handle.net/2445/173032Articles publicats en revistes (Medicina)reponame:Dipòsit Digital de la UBinstname:Universidad de BarcelonaInglésReproducció del document publicat a: https://doi.org/10.1111/liv.14462Liver International, 2020, vol. 40, num. 8, p. 2008-2020https://doi.org/10.1111/liv.14462cc by (c) Kudo et al., 2020http://creativecommons.org/licenses/by/3.0/es/info:eu-repo/semantics/openAccessoai:diposit.ub.edu:2445/1730322026-05-27T06:46:51Z
dc.title.none.fl_str_mv Ramucirumab in elderly patients with hepatocellular carcinoma and elevated alpha-fetoprotein after sorafenib in REACH and REACH-2
title Ramucirumab in elderly patients with hepatocellular carcinoma and elevated alpha-fetoprotein after sorafenib in REACH and REACH-2
spellingShingle Ramucirumab in elderly patients with hepatocellular carcinoma and elevated alpha-fetoprotein after sorafenib in REACH and REACH-2
Kudo, Masatoshi
Càncer de fetge
Anticossos monoclonals
Persones grans dependents
Liver cancer
Monoclonal antibodies
Frail elderly
title_short Ramucirumab in elderly patients with hepatocellular carcinoma and elevated alpha-fetoprotein after sorafenib in REACH and REACH-2
title_full Ramucirumab in elderly patients with hepatocellular carcinoma and elevated alpha-fetoprotein after sorafenib in REACH and REACH-2
title_fullStr Ramucirumab in elderly patients with hepatocellular carcinoma and elevated alpha-fetoprotein after sorafenib in REACH and REACH-2
title_full_unstemmed Ramucirumab in elderly patients with hepatocellular carcinoma and elevated alpha-fetoprotein after sorafenib in REACH and REACH-2
title_sort Ramucirumab in elderly patients with hepatocellular carcinoma and elevated alpha-fetoprotein after sorafenib in REACH and REACH-2
dc.creator.none.fl_str_mv Kudo, Masatoshi
Galle, Peter R.
Llovet i Bayer, Josep Maria
Finn, Richard S.
Vogel, Arndt
Motomura, Kenta
Assenat, Eric
Merle, Philippe
Brandi, Giovanni
Daniele, Bruno
Okusaka, Takuji
Tomášek, Jiří
Borg, Christophe
Dadduzio, Vincenzo
Morimoto, Manabu
Pracht, Marc
Jen, Min-Hua
Widau, Ryan C.
Shinozaki, Kenta
Yoshikawa, Reigetsu
Zhu, Andrew X.
author Kudo, Masatoshi
author_facet Kudo, Masatoshi
Galle, Peter R.
Llovet i Bayer, Josep Maria
Finn, Richard S.
Vogel, Arndt
Motomura, Kenta
Assenat, Eric
Merle, Philippe
Brandi, Giovanni
Daniele, Bruno
Okusaka, Takuji
Tomášek, Jiří
Borg, Christophe
Dadduzio, Vincenzo
Morimoto, Manabu
Pracht, Marc
Jen, Min-Hua
Widau, Ryan C.
Shinozaki, Kenta
Yoshikawa, Reigetsu
Zhu, Andrew X.
author_role author
author2 Galle, Peter R.
Llovet i Bayer, Josep Maria
Finn, Richard S.
Vogel, Arndt
Motomura, Kenta
Assenat, Eric
Merle, Philippe
Brandi, Giovanni
Daniele, Bruno
Okusaka, Takuji
Tomášek, Jiří
Borg, Christophe
Dadduzio, Vincenzo
Morimoto, Manabu
Pracht, Marc
Jen, Min-Hua
Widau, Ryan C.
Shinozaki, Kenta
Yoshikawa, Reigetsu
Zhu, Andrew X.
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv Càncer de fetge
Anticossos monoclonals
Persones grans dependents
Liver cancer
Monoclonal antibodies
Frail elderly
topic Càncer de fetge
Anticossos monoclonals
Persones grans dependents
Liver cancer
Monoclonal antibodies
Frail elderly
description Background & Aims: Limited data on treatment of elderly patients with hepatocellular carcinoma (HCC) increase the unmet need. REACH and REACH‐2 were global phase III studies of ramucirumab in patients with HCC after prior sorafenib, where patients with alpha‐fetoprotein (AFP) ≥400 ng/mL showed an overall ssurvival (OS) benefit for ramucirumab. These post‐hoc analyses examined efficacy and safety of ramucirumab in patients with HCC and baseline AFP ≥ 400 ng/mL by three prespecified age subgroups (<65, ≥65 to <75 and ≥75 years). Methods: Individual patient data were pooled from REACH (baseline AFP ≥400 ng/mL) and REACH‐2. Kaplan‐Meier and Cox proportional hazards regression methods (stratified by study) assessed OS, progression‐free survival (PFS), time to progression (TTP) and patient‐reported outcomes (Functional Hepatobiliary System Index‐8 [FHSI‐8] score). Results: A total of 542 patients (<65 years: n = 302; ≥65 to <75 years: n = 160; ≥75 years: n = 80) showed similar baseline characteristics between ramucirumab and placebo. Older subgroups had higher hepatitis C and steatohepatitis incidences, and lower AFP levels, than the <65 years subgroup. Ramucirumab prolonged OS in patients <65 years (hazard ratio [HR], 0.753; 95% CI 0.581‐0.975), ≥65 to <75 years (0.602; 0.419‐0.866) and ≥75 years (0.709; 0.420‐1.199), PFS and TTP irrespective of age. Ramucirumab showed similar overall safety profiles across subgroups, with a consistent median relative dose intensity ≥97.8%. A trend towards a delay in symptom deterioration in FHSI‐8 with ramucirumab was observed in all subgroups. Conclusions: In this post‐hoc analysis, ramucirumab showed a survival benefit across age subgroups with a tolerable safety profile, supporting its use in advanced HCC with elevated AFP, irrespective of age, including ≥75 years.
publishDate 2020
dc.date.none.fl_str_mv 2020
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://hdl.handle.net/2445/173032
url https://hdl.handle.net/2445/173032
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/10.1111/liv.14462
Liver International, 2020, vol. 40, num. 8, p. 2008-2020
https://doi.org/10.1111/liv.14462
dc.rights.none.fl_str_mv cc by (c) Kudo et al., 2020
http://creativecommons.org/licenses/by/3.0/es/
info:eu-repo/semantics/openAccess
rights_invalid_str_mv cc by (c) Kudo et al., 2020
http://creativecommons.org/licenses/by/3.0/es/
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv John Wiley & Sons
publisher.none.fl_str_mv John Wiley & Sons
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 15,301603

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