TY - JOUR
T1 - International and multicenter real-world study of sorafenib-treated patients with hepatocellular carcinoma under dialysis
AU - Díaz-González, Álvaro
AU - Sanduzzi-Zamparelli, Marco
AU - da Fonseca, Leonardo G.
AU - Di Costanzo, Giovan G.
AU - Alves, Rogerio
AU - Iavarone, Massimo
AU - Leal, Cassia
AU - Sacco, Rodolfo
AU - Matilla, Ana M.
AU - Hernández-Guerra, Manuel
AU - Aballay Soteras, Gabriel
AU - Wörns, Marcus Alexander
AU - Pinter, Matthias
AU - Varela, María
AU - Ladekarl, Morten
AU - Chagas, Aline L.
AU - Mínguez, Beatriz
AU - Arenas, Juan I.
AU - Granito, Alessandro
AU - Sánchez-Torrijos, Yolanda
AU - Rojas, Ángela
AU - Rodríguez de Lope, Carlos
AU - Alvares-da-Silva, Mario R.
AU - Pascual, Sonia
AU - Rimassa, Lorenza
AU - Lledó, José L.
AU - Huertas, Carlos
AU - Sangro, Bruno
AU - Giannini, Edoardo G.
AU - Delgado, Manuel
AU - Vergara, Mercedes
AU - Perelló, Christie
AU - Lue, Alberto
AU - Sala, Margarita
AU - Gallego, Adolfo
AU - Coll, Susanna
AU - Hernáez, Tania
AU - Piñero, Federico
AU - Pereira, Gustavo
AU - França, Alex
AU - Marín, Juan
AU - Anders, Margarita
AU - Mello, Vivianne
AU - Lozano, Mar
AU - Nault, Jean C.
AU - Menéndez, Josemaría
AU - García Juárez, Ignacio
AU - Bruix, Jordi
AU - Reig, María
PY - 2020/1/1
Y1 - 2020/1/1
N2 - 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.
AB - 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.
KW - adverse events
KW - dialysis
KW - Hepatocellular carcinoma
KW - safety
KW - sorafenib
KW - survival
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UR - http://www.scopus.com/inward/citedby.url?scp=85083419935&partnerID=8YFLogxK
U2 - 10.1111/liv.14436
DO - 10.1111/liv.14436
M3 - Article
C2 - 32170821
AN - SCOPUS:85083419935
JO - Liver International
JF - Liver International
SN - 1478-3223
ER -