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

Álvaro Díaz-González, Marco Sanduzzi-Zamparelli, Leonardo G. da Fonseca, Giovan G. Di Costanzo, Rogerio Alves, Massimo Iavarone, Cassia Leal, Rodolfo Sacco, Ana M. Matilla, Manuel Hernández-Guerra, Gabriel Aballay Soteras, Marcus Alexander Wörns, Matthias Pinter, María Varela, Morten Ladekarl, Aline L. Chagas, Beatriz Mínguez, Juan I. Arenas, Alessandro Granito, Yolanda Sánchez-TorrijosÁngela Rojas, Carlos Rodríguez de Lope, Mario R. Alvares-da-Silva, Sonia Pascual, Lorenza Rimassa, José L. Lledó, Carlos Huertas, Bruno Sangro, Edoardo G. Giannini, Manuel Delgado, Mercedes Vergara, Christie Perelló, Alberto Lue, Margarita Sala, Adolfo Gallego, Susanna Coll, Tania Hernáez, Federico Piñero, Gustavo Pereira, Alex França, Juan Marín, Margarita Anders, Vivianne Mello, Mar Lozano, Jean C. Nault, Josemaría Menéndez, Ignacio García Juárez, Jordi Bruix, María Reig

Research output: Contribution to journalArticle

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.

Original languageEnglish
JournalLiver International
DOIs
Publication statusAccepted/In press - Jan 1 2020

Keywords

  • adverse events
  • dialysis
  • Hepatocellular carcinoma
  • safety
  • sorafenib
  • survival

ASJC Scopus subject areas

  • Hepatology

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    Díaz-González, Á., Sanduzzi-Zamparelli, M., da Fonseca, L. G., Di Costanzo, G. G., Alves, R., Iavarone, M., Leal, C., Sacco, R., Matilla, A. M., Hernández-Guerra, M., Aballay Soteras, G., Wörns, M. A., Pinter, M., Varela, M., Ladekarl, M., Chagas, A. L., Mínguez, B., Arenas, J. I., Granito, A., ... Reig, M. (Accepted/In press). International and multicenter real-world study of sorafenib-treated patients with hepatocellular carcinoma under dialysis. Liver International. https://doi.org/10.1111/liv.14436