International and multicenter real-world study of sorafenib-treated patients with hepatocellular carcinoma under dialysis

Background & Aims Information on safety and efficacy of systemic treatment in patients with hepatocellular carcinoma (HCC) under dialysis are limited due to patient exclusion from clinical trials. Thus, we aimed to evaluate the rate, prevalence, tolerability, and outcome of sorafenib in this pop...

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Autores: Diaz-Gonzalez, A, Sanduzzi-Zamparelli, M, Fonseca, LG, Di Costanzo, GG, Alves, R, Iavarone, M, Leal, C, Sacco, R, Matilla, AM, Hernandez-Guerra, M, Soteras, GA, Worns, MA, Pinter, M, Varela, M, Ladekarl, M, Chagas, AL, Minguez, B, Arenas, JI, Granito, A, Sanchez-Torrijos, Y, Rojas, A, de Lope, CR, Alvares-da-Silva, MR, Pascual, S, Rimassa, L, Lledo, JL, Huertas, C, Sangro, B, Giannini, EG, Delgado, M, Vergara, M, Perello, C, Lue, A, Sala, M, Gallego, A, Coll, S, Hernaez, T, Pinero, F, Pereira, G, Franca, A, Marin, J, Anders, M, Mello, V, Lozano, M, Nault, JC, Menendez, J, Juarez, IG, Bruix, J, Reig, M
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2020
País:España
Institución:Institut d'Investigació i Innovació Parc Taulí (I3PT)
Repositorio:r-I3PT. Repositorio Institucional Producción Científica del Institut d'Investigació i Innovació Parc Taulí
OAI Identifier:oai:i3pt.fundanetsuite.com:p2663
Acceso en línea:https://i3pt.portalinvestigacion.com/publicaciones/2663
Access Level:acceso abierto
Palabra clave:adverse events
dialysis
Hepatocellular carcinoma
safety
sorafenib
survival
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spelling International and multicenter real-world study of sorafenib-treated patients with hepatocellular carcinoma under dialysisDiaz-Gonzalez, ASanduzzi-Zamparelli, MFonseca, LGDi Costanzo, GGAlves, RIavarone, MLeal, CSacco, RMatilla, AMHernandez-Guerra, MSoteras, GAWorns, MAPinter, MVarela, MLadekarl, MChagas, ALMinguez, BArenas, JIGranito, ASanchez-Torrijos, YRojas, Ade Lope, CRAlvares-da-Silva, MRPascual, SRimassa, LLledo, JLHuertas, CSangro, BGiannini, EGDelgado, MVergara, MPerello, CLue, ASala, MGallego, AColl, SHernaez, TPinero, FPereira, GFranca, AMarin, JAnders, MMello, VLozano, MNault, JCMenendez, JJuarez, IGBruix, JReig, Madverse eventsdialysisHepatocellular carcinomasafetysorafenibsurvivalBackground & Aims Information on safety and efficacy of systemic treatment in patients with hepatocellular carcinoma (HCC) under dialysis are limited due to patient exclusion from clinical trials. Thus, we aimed to evaluate the rate, prevalence, tolerability, and outcome of sorafenib in this population. Methods We report a multicenter study comprising patients from Latin America and Europe. Patients treated with sorafenib were enrolled; demographics, dose modifications, adverse events (AEs), treatment duration, and outcome of patients undergoing dialysis were recorded. Results As of March 2018, 6156 HCC patients were treated in 44 centres and 22 patients were concomitantly under dialysis (0.36%). The median age was 65.5 years, 40.9% had hepatitis C, 75% had Child-Pugh A, and 85% were Barcelona Clinic Liver Cancer-C. The median time to first dose modification, treatment duration and overall survival rate were 2.4 months (interquartile ranges [IQR], 0.8-3.8), 10.8 months (IQR, 4.5-16.9), and 17.5 months (95% CI, 7.2-24.5), respectively. Seventeen patients required at least 1 dose modification. The main causes of first dose modification were asthenia/worsening of Eastern Cooperative Oncology Group-Performance Status and diarrhoea. At the time of death or last follow-up, four patients were still on treatment and 18 had discontinued sorafenib: 14 were due to tumour progression, 2 were sorafenib-related, and 2 were non-sorafenib-related AE. Conclusions The outcomes observed in this cohort seem comparable to those in the non-dialysis population. Thus, to the best of our knowledge, this is the largest and most informative dataset regarding systemic treatment outcomes in HCC patients undergoing dialysis.WILEY2020info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttps://i3pt.portalinvestigacion.com/publicaciones/2663LIVER INTERNATIONALISSN: 14783223ISSNe: 14783231reponame:r-I3PT. Repositorio Institucional Producción Científica del Institut d'Investigació i Innovació Parc Taulíinstname:Institut d'Investigació i Innovació Parc Taulí (I3PT)Inglésinfo:eu-repo/semantics/openAccessoai:i3pt.fundanetsuite.com:p26632026-06-21T15:30:37Z
dc.title.none.fl_str_mv International and multicenter real-world study of sorafenib-treated patients with hepatocellular carcinoma under dialysis
title International and multicenter real-world study of sorafenib-treated patients with hepatocellular carcinoma under dialysis
spellingShingle International and multicenter real-world study of sorafenib-treated patients with hepatocellular carcinoma under dialysis
Diaz-Gonzalez, A
adverse events
dialysis
Hepatocellular carcinoma
safety
sorafenib
survival
title_short International and multicenter real-world study of sorafenib-treated patients with hepatocellular carcinoma under dialysis
title_full International and multicenter real-world study of sorafenib-treated patients with hepatocellular carcinoma under dialysis
title_fullStr International and multicenter real-world study of sorafenib-treated patients with hepatocellular carcinoma under dialysis
title_full_unstemmed International and multicenter real-world study of sorafenib-treated patients with hepatocellular carcinoma under dialysis
title_sort International and multicenter real-world study of sorafenib-treated patients with hepatocellular carcinoma under dialysis
dc.creator.none.fl_str_mv Diaz-Gonzalez, A
Sanduzzi-Zamparelli, M
Fonseca, LG
Di Costanzo, GG
Alves, R
Iavarone, M
Leal, C
Sacco, R
Matilla, AM
Hernandez-Guerra, M
Soteras, GA
Worns, MA
Pinter, M
Varela, M
Ladekarl, M
Chagas, AL
Minguez, B
Arenas, JI
Granito, A
Sanchez-Torrijos, Y
Rojas, A
de Lope, CR
Alvares-da-Silva, MR
Pascual, S
Rimassa, L
Lledo, JL
Huertas, C
Sangro, B
Giannini, EG
Delgado, M
Vergara, M
Perello, C
Lue, A
Sala, M
Gallego, A
Coll, S
Hernaez, T
Pinero, F
Pereira, G
Franca, A
Marin, J
Anders, M
Mello, V
Lozano, M
Nault, JC
Menendez, J
Juarez, IG
Bruix, J
Reig, M
author Diaz-Gonzalez, A
author_facet Diaz-Gonzalez, A
Sanduzzi-Zamparelli, M
Fonseca, LG
Di Costanzo, GG
Alves, R
Iavarone, M
Leal, C
Sacco, R
Matilla, AM
Hernandez-Guerra, M
Soteras, GA
Worns, MA
Pinter, M
Varela, M
Ladekarl, M
Chagas, AL
Minguez, B
Arenas, JI
Granito, A
Sanchez-Torrijos, Y
Rojas, A
de Lope, CR
Alvares-da-Silva, MR
Pascual, S
Rimassa, L
Lledo, JL
Huertas, C
Sangro, B
Giannini, EG
Delgado, M
Vergara, M
Perello, C
Lue, A
Sala, M
Gallego, A
Coll, S
Hernaez, T
Pinero, F
Pereira, G
Franca, A
Marin, J
Anders, M
Mello, V
Lozano, M
Nault, JC
Menendez, J
Juarez, IG
Bruix, J
Reig, M
author_role author
author2 Sanduzzi-Zamparelli, M
Fonseca, LG
Di Costanzo, GG
Alves, R
Iavarone, M
Leal, C
Sacco, R
Matilla, AM
Hernandez-Guerra, M
Soteras, GA
Worns, MA
Pinter, M
Varela, M
Ladekarl, M
Chagas, AL
Minguez, B
Arenas, JI
Granito, A
Sanchez-Torrijos, Y
Rojas, A
de Lope, CR
Alvares-da-Silva, MR
Pascual, S
Rimassa, L
Lledo, JL
Huertas, C
Sangro, B
Giannini, EG
Delgado, M
Vergara, M
Perello, C
Lue, A
Sala, M
Gallego, A
Coll, S
Hernaez, T
Pinero, F
Pereira, G
Franca, A
Marin, J
Anders, M
Mello, V
Lozano, M
Nault, JC
Menendez, J
Juarez, IG
Bruix, J
Reig, M
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
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 adverse events
dialysis
Hepatocellular carcinoma
safety
sorafenib
survival
topic adverse events
dialysis
Hepatocellular carcinoma
safety
sorafenib
survival
description Background & Aims Information on safety and efficacy of systemic treatment in patients with hepatocellular carcinoma (HCC) under dialysis are limited due to patient exclusion from clinical trials. Thus, we aimed to evaluate the rate, prevalence, tolerability, and outcome of sorafenib in this population. Methods We report a multicenter study comprising patients from Latin America and Europe. Patients treated with sorafenib were enrolled; demographics, dose modifications, adverse events (AEs), treatment duration, and outcome of patients undergoing dialysis were recorded. Results As of March 2018, 6156 HCC patients were treated in 44 centres and 22 patients were concomitantly under dialysis (0.36%). The median age was 65.5 years, 40.9% had hepatitis C, 75% had Child-Pugh A, and 85% were Barcelona Clinic Liver Cancer-C. The median time to first dose modification, treatment duration and overall survival rate were 2.4 months (interquartile ranges [IQR], 0.8-3.8), 10.8 months (IQR, 4.5-16.9), and 17.5 months (95% CI, 7.2-24.5), respectively. Seventeen patients required at least 1 dose modification. The main causes of first dose modification were asthenia/worsening of Eastern Cooperative Oncology Group-Performance Status and diarrhoea. At the time of death or last follow-up, four patients were still on treatment and 18 had discontinued sorafenib: 14 were due to tumour progression, 2 were sorafenib-related, and 2 were non-sorafenib-related AE. Conclusions The outcomes observed in this cohort seem comparable to those in the non-dialysis population. Thus, to the best of our knowledge, this is the largest and most informative dataset regarding systemic treatment outcomes in HCC patients undergoing dialysis.
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://i3pt.portalinvestigacion.com/publicaciones/2663
url https://i3pt.portalinvestigacion.com/publicaciones/2663
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.publisher.none.fl_str_mv WILEY
publisher.none.fl_str_mv WILEY
dc.source.none.fl_str_mv LIVER INTERNATIONAL
ISSN: 14783223
ISSNe: 14783231
reponame:r-I3PT. Repositorio Institucional Producción Científica del Institut d'Investigació i Innovació Parc Taulí
instname:Institut d'Investigació i Innovació Parc Taulí (I3PT)
instname_str Institut d'Investigació i Innovació Parc Taulí (I3PT)
reponame_str r-I3PT. Repositorio Institucional Producción Científica del Institut d'Investigació i Innovació Parc Taulí
collection r-I3PT. Repositorio Institucional Producción Científica del Institut d'Investigació i Innovació Parc Taulí
repository.name.fl_str_mv
repository.mail.fl_str_mv
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