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Multicenter Study
. 2020 Jun;40(6):1467-1476.
doi: 10.1111/liv.14436. Epub 2020 Apr 15.

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

Álvaro Díaz-González  1 , Marco Sanduzzi-Zamparelli  1 , Leonardo G da Fonseca  1 , Giovan G Di Costanzo  2 , Rogerio Alves  3 , Massimo Iavarone  4 , Cassia Leal  5 , Rodolfo Sacco  6 , Ana M Matilla  7 , Manuel Hernández-Guerra  8 , Gabriel Aballay Soteras  9 , Marcus-Alexander Wörns  10 , Matthias Pinter  11 , María Varela  12 , Morten Ladekarl  13 , Aline L Chagas  14 , Beatriz Mínguez  15 , Juan I Arenas  16 , Alessandro Granito  17 , Yolanda Sánchez-Torrijos  18 , Ángela Rojas  18 , Carlos Rodríguez de Lope  19 , Mario R Alvares-da-Silva  20 , Sonia Pascual  21 , Lorenza Rimassa  22   23 , José L Lledó  24 , Carlos Huertas  25 , Bruno Sangro  26 , Edoardo G Giannini  27 , Manuel Delgado  28 , Mercedes Vergara  29 , Christie Perelló  30 , Alberto Lue  31 , Margarita Sala  32 , Adolfo Gallego  33 , Susanna Coll  34 , Tania Hernáez  35 , Federico Piñero  36 , Gustavo Pereira  37 , Alex França  38 , Juan Marín  39 , Margarita Anders  40 , Vivianne Mello  41 , Mar Lozano  42 , Jean C Nault  43 , Josemaría Menéndez  44 , Ignacio García Juárez  45 , Jordi Bruix  1 , María Reig  1
Affiliations
Multicenter Study

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

Álvaro Díaz-González et al. Liver Int. 2020 Jun.

Abstract

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.

Keywords: Hepatocellular carcinoma; adverse events; dialysis; safety; sorafenib; survival.

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References

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