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International and multicenter real‐world study of sorafenib‐treated patients with hepatocellular carcinoma under dialysis
Author(s) -
DíazGonzález Álvaro,
SanduzziZamparelli Marco,
Fonseca Leonardo G.,
Di Costanzo Giovan G.,
Alves Rogerio,
Iavarone Massimo,
Leal Cassia,
Sacco Rodolfo,
Matilla Ana M.,
HernándezGuerra Manuel,
Aballay Soteras Gabriel,
Wörns MarcusAlexander,
Pinter Matthias,
Varela María,
Ladekarl Morten,
Chagas Aline L.,
Mínguez Beatriz,
Arenas Juan I.,
Granito Alessandro,
SánchezTorrijos Yolanda,
Rojas Ángela,
Rodríguez de Lope Carlos,
AlvaresdaSilva Mario R.,
Pascual Sonia,
Rimassa Lorenza,
Lledó José L.,
Huertas Carlos,
Sangro Bruno,
Giannini Edoardo G.,
Delgado Manuel,
Vergara Mercedes,
Perelló Christie,
Lue Alberto,
Sala Margarita,
Gallego Adolfo,
Coll Susanna,
Hernáez Tania,
Piñero Federico,
Pereira Gustavo,
França Alex,
Marín Juan,
Anders Margarita,
Mello Vivianne,
Lozano Mar,
Nault Jean C.,
Menéndez Josemaría,
García Juárez Ignacio,
Bruix Jordi,
Reig María
Publication year - 2020
Publication title -
liver international
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.873
H-Index - 110
eISSN - 1478-3231
pISSN - 1478-3223
DOI - 10.1111/liv.14436
Subject(s) - medicine , sorafenib , hepatocellular carcinoma , interquartile range , tolerability , dialysis , population , adverse effect , hepatitis c , surgery , gastroenterology , environmental health
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.