PMID- 32170821 OWN - NLM STAT- MEDLINE DCOM- 20210621 LR - 20210621 IS - 1478-3231 (Electronic) IS - 1478-3223 (Linking) VI - 40 IP - 6 DP - 2020 Jun TI - International and multicenter real-world study of sorafenib-treated patients with hepatocellular carcinoma under dialysis. PG - 1467-1476 LID - 10.1111/liv.14436 [doi] 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. CI - (c) 2020 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd. FAU - Diaz-Gonzalez, Alvaro AU - Diaz-Gonzalez A AUID- ORCID: 0000-0003-3610-2263 AD - Barcelona Clinic Liver Cancer (BCLC) Group, Liver Unit, Hospital Clinic of Barcelona, IDIBAPS, Barcelona, Spain. FAU - Sanduzzi-Zamparelli, Marco AU - Sanduzzi-Zamparelli M AUID- ORCID: 0000-0003-3795-3705 AD - Barcelona Clinic Liver Cancer (BCLC) Group, Liver Unit, Hospital Clinic of Barcelona, IDIBAPS, Barcelona, Spain. FAU - da Fonseca, Leonardo G AU - da Fonseca LG AUID- ORCID: 0000-0002-0216-3618 AD - Barcelona Clinic Liver Cancer (BCLC) Group, Liver Unit, Hospital Clinic of Barcelona, IDIBAPS, Barcelona, Spain. FAU - Di Costanzo, Giovan G AU - Di Costanzo GG AUID- ORCID: 0000-0001-8901-1811 AD - Department of Transplantation, Liver Unit, Cardarelli Hospital, Naples, Italy. FAU - Alves, Rogerio AU - Alves R AD - State Public Hospital, Sao Paulo, Brazil. FAU - Iavarone, Massimo AU - Iavarone M AUID- ORCID: 0000-0003-3493-6504 AD - CRC "A. M. and A. Migliavacca" Center for Liver Disease, Division of Gastroenterology and Hepatology, IRCCS Ca Granda Ospedale Maggiore Policlinico, University of Milan, Milan, Italy. FAU - Leal, Cassia AU - Leal C AD - Gastroenterology and Hepatology Department, Federal Hospital of State Servants and Fluminense Federal University (Hospital Universitario Antonio Pedro), Rio de Janeiro, Brazil. FAU - Sacco, Rodolfo AU - Sacco R AD - Gastroenterology and Metabolic Diseases, Pisa University Hospital, Pisa, Italy. FAU - Matilla, Ana M AU - Matilla AM AD - Digestive Diseases Department, University General Hospital Gregorio Maranon, Madrid, Spain. FAU - Hernandez-Guerra, Manuel AU - Hernandez-Guerra M AUID- ORCID: 0000-0002-3478-9981 AD - Liver Unit, Canary Island University Hospital, La Laguna, Spain. FAU - Aballay Soteras, Gabriel AU - Aballay Soteras G AD - Liver Transplant Unit, Hospital General de Agudos Dr Cosme Argerich, Buenos Aires Autonomous City, Argentina. FAU - Worns, Marcus-Alexander AU - Worns MA AUID- ORCID: 0000-0001-5815-7789 AD - First Department of Medicine, University Medical Centre of the Johannes Gutenberg-University Mainz, Mainz, Germany. FAU - Pinter, Matthias AU - Pinter M AUID- ORCID: 0000-0002-7260-532X AD - Division of Gastroenterology & Hepatology, Department of Internal Medicine III, Vienna Liver Cancer Study Group, AKH & Medical University of Vienna, Vienna, Austria. FAU - Varela, Maria AU - Varela M AUID- ORCID: 0000-0003-4288-2593 AD - Liver Unit, Central University Hospital of Asturias, Institute of Oncology of Asturias (IUOPA), Foundation for Biosanitary Research and Innovation of the Principality of Asturias (FINBA), Oviedo, Spain. FAU - Ladekarl, Morten AU - Ladekarl M AD - Department of Oncology, Aarhus University Hospital, and Department of Oncology, Clinical Cancer Research Center, Aalborg University Hospital, Aarhus, Denmark. FAU - Chagas, Aline L AU - Chagas AL AUID- ORCID: 0000-0002-7404-2540 AD - Division of Clinical Gastroenterology and Hepatology, Department of Gastroenterology, University of Sao Paulo School of Medicine, Cancer Institute of the State of Sao Paulo, Sao Paulo, Brazil. FAU - Minguez, Beatriz AU - Minguez B AD - Liver Unit, Department of Internal Medicine, Vall d'Hebron University Hospital, Vall d'Hebron Institut of Research, Center for Biomedical Research in Liver and Digestive Diseases Network (CIBERehd), Autonomous University of Barcelona, Barcelona, Spain. FAU - Arenas, Juan I AU - Arenas JI AD - Digestive Diseases Department, Donostia University Hospital, San Sebastian, Spain. FAU - Granito, Alessandro AU - Granito A AD - Unit of Internal Medicine, Department of Medical and Surgical Sciences, University of Bologna, Bologna, Italy. FAU - Sanchez-Torrijos, Yolanda AU - Sanchez-Torrijos Y AD - UCM Digestive Diseases and Center for Biomedical Research in Liver and Digestive Diseases Network (CIBERehd), Institute of Biomedicine of Seville (IBiS), SeLiver Group, Virgen del Rocio/CSIC/US, Sevilla, Spain. FAU - Rojas, Angela AU - Rojas A AD - UCM Digestive Diseases and Center for Biomedical Research in Liver and Digestive Diseases Network (CIBERehd), Institute of Biomedicine of Seville (IBiS), SeLiver Group, Virgen del Rocio/CSIC/US, Sevilla, Spain. FAU - Rodriguez de Lope, Carlos AU - Rodriguez de Lope C AD - Digestive Diseases Department, Marques de Valdecilla University Hospital, Marques de Valdecilla Research Institute (IDIVAL), Santander, Spain. FAU - Alvares-da-Silva, Mario R AU - Alvares-da-Silva MR AD - GI/Liver Unit, Hospital de Clinicas de Porto Alegre, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil. FAU - Pascual, Sonia AU - Pascual S AD - Hepatic Unit, Gastroenterology Service, General University Hospital of Alicante, Center for Biomedical Research in Liver and Digestive Diseases Network (CIBERehd), Alicante, Spain. FAU - Rimassa, Lorenza AU - Rimassa L AUID- ORCID: 0000-0001-9957-3615 AD - Medical Oncology and Hematology Unit, Humanitas Cancer Center, Humanitas Clinical and Research Center - IRCCS, Milan, Italy. AD - Department of Biomedical Sciences, Humanitas University, Milan, Italy. FAU - Lledo, Jose L AU - Lledo JL AD - Gastroenterology and Liver Diseases department, Ramon y Cajal University Hospital, Center for Biomedical Research in Liver and Digestive Diseases Network (CIBERehd), Madrid, Spain. FAU - Huertas, Carlos AU - Huertas C AD - Digestive Diseases Department, Doctor Josep Trueta University Hospital, Girona, Spain. FAU - Sangro, Bruno AU - Sangro B AD - Liver Unit, University of Navarra Clinic, Health Research Institute of Navarra (IDISNA), Center for Biomedical Research in Liver and Digestive Diseases Network (CIBERehd), Pamplona, Spain. FAU - Giannini, Edoardo G AU - Giannini EG AUID- ORCID: 0000-0001-8526-837X AD - Gastroenterology Unit, Department of Internal Medicine, IRCCS-San Martino Policlinico Hospital, University of Genoa, Genoa, Italy. FAU - Delgado, Manuel AU - Delgado M AD - Digestive Diseases Department, La Coruna University Hospital, A Coruna, Spain. FAU - Vergara, Mercedes AU - Vergara M AD - Liver Unit, Digestive Diseases Department, Parc Tauli University Hospital, Parc Tauli I3PT Research and Innovation Institute, Autonomous University of Barcelona, Sabadell, Spain. FAU - Perello, Christie AU - Perello C AD - Liver Unit, Puerta de Hierro University Hospital, Puerta de Hierro Majadahonda Health Research Institute (IDIPHISA), Madrid, Spain. FAU - Lue, Alberto AU - Lue A AUID- ORCID: 0000-0002-9672-6038 AD - Digestive Diseases Department, Hepatology Unit and Liver Transplant, Lozano Blesa Clinical University Hospital, Zaragoza, Spain. FAU - Sala, Margarita AU - Sala M AD - Liver Unit, Digestive Diseases Department, Germans Trias i Pujol University Hospital, Center for Biomedical Research in Liver and Digestive Diseases Network (CIBERehd), Badalona, Spain. FAU - Gallego, Adolfo AU - Gallego A AD - Digestive Diseases Department, Santa Creu i Sant Pau University Hospital, Barcelona, Spain. FAU - Coll, Susanna AU - Coll S AD - Liver Section, Gastroenterology Department, Hospital del Mar, IMIM Hospital del Mar Medical Research Institute, Barcelona, Spain. FAU - Hernaez, Tania AU - Hernaez T AD - Digestive Diseases Department, San Pedro Hospital, Logrono, Spain. FAU - Pinero, Federico AU - Pinero F AD - Liver Unit, Austral University Hospital, Buenos Aires, Argentina. FAU - Pereira, Gustavo AU - Pereira G AUID- ORCID: 0000-0003-2768-9605 AD - Gastroenterology and Hepatology Unit, Bonsucesso Federal Hospital, Ministry of Health, Rio de Janeiro, Brazil. FAU - Franca, Alex AU - Franca A AD - Liver Unit, Department of Medicine, Federal University of Sergipe, Sergipe, Brazil. FAU - Marin, Juan AU - Marin J AD - Pablo Tobon Uribe Hospital, Medellin, Colombia. FAU - Anders, Margarita AU - Anders M AD - Liver Diseases and Liver Transplant Unit, German Hospital, Buenos Aires, Argentina. FAU - Mello, Vivianne AU - Mello V AD - Multidisciplinary Assistance in Oncology (AMO) Clinic, Salvador, Brazil. FAU - Lozano, Mar AU - Lozano M AD - Digestive Diseases Department, Infanta Leonor University Hospital, Madrid, Spain. FAU - Nault, Jean C AU - Nault JC AUID- ORCID: 0000-0002-4875-9353 AD - Cordeliers Research Center, Sorbonne University, Inserm, USPC, Paris Descartes University, Paris Diderot University, Paris 13 University, Functional Genomics of Solid Tumors Laboratory, Jean Verdier Hospital, Paris-Seine-Saint University Hospital -Denis, Public Assistance Hospitals of Paris, Bondy, France. FAU - Menendez, Josemaria AU - Menendez J AD - Liver Transplant and Liver Diseases Unit, Central Hospital of the Armed Forces (Military Hospital), Montevideo, Uruguay. FAU - Garcia Juarez, Ignacio AU - Garcia Juarez I AD - Gastroenterology Department, National Institute of Medical Sciences and Nutrition Salvador Zubiran, City of Mexico, Mexico. FAU - Bruix, Jordi AU - Bruix J AUID- ORCID: 0000-0002-9826-0753 AD - Barcelona Clinic Liver Cancer (BCLC) Group, Liver Unit, Hospital Clinic of Barcelona, IDIBAPS, Barcelona, Spain. FAU - Reig, Maria AU - Reig M AUID- ORCID: 0000-0002-5711-9534 AD - Barcelona Clinic Liver Cancer (BCLC) Group, Liver Unit, Hospital Clinic of Barcelona, IDIBAPS, Barcelona, Spain. LA - eng PT - Journal Article PT - Multicenter Study PT - Research Support, Non-U.S. Gov't DEP - 20200415 PL - United States TA - Liver Int JT - Liver international : official journal of the International Association for the Study of the Liver JID - 101160857 RN - 0 (Antineoplastic Agents) RN - 0 (Phenylurea Compounds) RN - 25X51I8RD4 (Niacinamide) RN - 9ZOQ3TZI87 (Sorafenib) SB - IM MH - Aged MH - *Antineoplastic Agents/adverse effects MH - *Carcinoma, Hepatocellular/drug therapy MH - Europe MH - Humans MH - *Liver Neoplasms/drug therapy MH - Niacinamide/adverse effects MH - Phenylurea Compounds/adverse effects MH - Renal Dialysis MH - Sorafenib/therapeutic use MH - Treatment Outcome OTO - NOTNLM OT - Hepatocellular carcinoma OT - adverse events OT - dialysis OT - safety OT - sorafenib OT - survival EDAT- 2020/03/15 06:00 MHDA- 2021/06/22 06:00 CRDT- 2020/03/15 06:00 PHST- 2019/12/28 00:00 [received] PHST- 2020/03/06 00:00 [revised] PHST- 2020/03/09 00:00 [accepted] PHST- 2020/03/15 06:00 [pubmed] PHST- 2021/06/22 06:00 [medline] PHST- 2020/03/15 06:00 [entrez] AID - 10.1111/liv.14436 [doi] PST - ppublish SO - Liver Int. 2020 Jun;40(6):1467-1476. doi: 10.1111/liv.14436. Epub 2020 Apr 15.