Álvaro Díaz-González1, Marco Sanduzzi-Zamparelli1, Leonardo G da Fonseca1, Giovan G Di Costanzo2, Rogerio Alves3, Massimo Iavarone4, Cassia Leal5, Rodolfo Sacco6, Ana M Matilla7, Manuel Hernández-Guerra8, Gabriel Aballay Soteras9, Marcus-Alexander Wörns10, Matthias Pinter11, María Varela12, Morten Ladekarl13, Aline L Chagas14, Beatriz Mínguez15, Juan I Arenas16, Alessandro Granito17, Yolanda Sánchez-Torrijos18, Ángela Rojas18, Carlos Rodríguez de Lope19, Mario R Alvares-da-Silva20, Sonia Pascual21, Lorenza Rimassa22,23, José L Lledó24, Carlos Huertas25, Bruno Sangro26, Edoardo G Giannini27, Manuel Delgado28, Mercedes Vergara29, Christie Perelló30, Alberto Lue31, Margarita Sala32, Adolfo Gallego33, Susanna Coll34, Tania Hernáez35, Federico Piñero36, Gustavo Pereira37, Alex França38, Juan Marín39, Margarita Anders40, Vivianne Mello41, Mar Lozano42, Jean C Nault43, Josemaría Menéndez44, Ignacio García Juárez45, Jordi Bruix1, María Reig1. 1. Barcelona Clínic Liver Cancer (BCLC) Group, Liver Unit, Hospital Clínic of Barcelona, IDIBAPS, Barcelona, Spain. 2. Department of Transplantation, Liver Unit, Cardarelli Hospital, Naples, Italy. 3. State Public Hospital, Sao Paulo, Brazil. 4. CRC "A. M. and A. Migliavacca" Center for Liver Disease, Division of Gastroenterology and Hepatology, IRCCS Cà Granda Ospedale Maggiore Policlinico, University of Milan, Milan, Italy. 5. Gastroenterology and Hepatology Department, Federal Hospital of State Servants and Fluminense Federal University (Hospital Universitário Antônio Pedro), Río de Janeiro, Brazil. 6. Gastroenterology and Metabolic Diseases, Pisa University Hospital, Pisa, Italy. 7. Digestive Diseases Department, University General Hospital Gregorio Marañón, Madrid, Spain. 8. Liver Unit, Canary Island University Hospital, La Laguna, Spain. 9. Liver Transplant Unit, Hospital General de Agudos Dr Cosme Argerich, Buenos Aires Autonomous City, Argentina. 10. First Department of Medicine, University Medical Centre of the Johannes Gutenberg-University Mainz, Mainz, Germany. 11. Division of Gastroenterology & Hepatology, Department of Internal Medicine III, Vienna Liver Cancer Study Group, AKH & Medical University of Vienna, Vienna, Austria. 12. 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. 13. Department of Oncology, Aarhus University Hospital, and Department of Oncology, Clinical Cancer Research Center, Aalborg University Hospital, Aarhus, Denmark. 14. Division of Clinical Gastroenterology and Hepatology, Department of Gastroenterology, University of São Paulo School of Medicine, Cancer Institute of the State of São Paulo, Sao Paulo, Brazil. 15. 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. 16. Digestive Diseases Department, Donostia University Hospital, San Sebastián, Spain. 17. Unit of Internal Medicine, Department of Medical and Surgical Sciences, University of Bologna, Bologna, Italy. 18. 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 Rocío/CSIC/US, Sevilla, Spain. 19. Digestive Diseases Department, Marqués de Valdecilla University Hospital, Marqués de Valdecilla Research Institute (IDIVAL), Santander, Spain. 20. GI/Liver Unit, Hospital de Clínicas de Porto Alegre, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil. 21. Hepatic Unit, Gastroenterology Service, General University Hospital of Alicante, Center for Biomedical Research in Liver and Digestive Diseases Network (CIBERehd), Alicante, Spain. 22. Medical Oncology and Hematology Unit, Humanitas Cancer Center, Humanitas Clinical and Research Center - IRCCS, Milan, Italy. 23. Department of Biomedical Sciences, Humanitas University, Milan, Italy. 24. Gastroenterology and Liver Diseases department, Ramón y Cajal University Hospital, Center for Biomedical Research in Liver and Digestive Diseases Network (CIBERehd), Madrid, Spain. 25. Digestive Diseases Department, Doctor Josep Trueta University Hospital, Girona, Spain. 26. 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. 27. Gastroenterology Unit, Department of Internal Medicine, IRCCS-San Martino Policlinico Hospital, University of Genoa, Genoa, Italy. 28. Digestive Diseases Department, La Coruña University Hospital, A Coruña, Spain. 29. Liver Unit, Digestive Diseases Department, Parc Taulí University Hospital, Parc Taulí I3PT Research and Innovation Institute, Autonomous University of Barcelona, Sabadell, Spain. 30. Liver Unit, Puerta de Hierro University Hospital, Puerta de Hierro Majadahonda Health Research Institute (IDIPHISA), Madrid, Spain. 31. Digestive Diseases Department, Hepatology Unit and Liver Transplant, Lozano Blesa Clinical University Hospital, Zaragoza, Spain. 32. Liver Unit, Digestive Diseases Department, Germans Trias i Pujol University Hospital, Center for Biomedical Research in Liver and Digestive Diseases Network (CIBERehd), Badalona, Spain. 33. Digestive Diseases Department, Santa Creu i Sant Pau University Hospital, Barcelona, Spain. 34. Liver Section, Gastroenterology Department, Hospital del Mar, IMIM Hospital del Mar Medical Research Institute, Barcelona, Spain. 35. Digestive Diseases Department, San Pedro Hospital, Logroño, Spain. 36. Liver Unit, Austral University Hospital, Buenos Aires, Argentina. 37. Gastroenterology and Hepatology Unit, Bonsucesso Federal Hospital, Ministry of Health, Río de Janeiro, Brazil. 38. Liver Unit, Department of Medicine, Federal University of Sergipe, Sergipe, Brazil. 39. Pablo Tobón Uribe Hospital, Medellín, Colombia. 40. Liver Diseases and Liver Transplant Unit, German Hospital, Buenos Aires, Argentina. 41. Multidisciplinary Assistance in Oncology (AMO) Clinic, Salvador, Brazil. 42. Digestive Diseases Department, Infanta Leonor University Hospital, Madrid, Spain. 43. 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. 44. Liver Transplant and Liver Diseases Unit, Central Hospital of the Armed Forces (Military Hospital), Montevideo, Uruguay. 45. Gastroenterology Department, National Institute of Medical Sciences and Nutrition Salvador Zubirán, City of Mexico, Mexico.
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.
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.
Authors: Ângelo Z Mattos; Jose D Debes; Arndt Vogel; Marco Arrese; Xavier Revelo; Tales Henrique S Pase; Muriel Manica; Angelo A Mattos Journal: World J Gastroenterol Date: 2022-07-28 Impact factor: 5.374