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Am J Transplant. 2019 Jul 31. doi: 10.1111/ajt.15551. [Epub ahead of print]

Preliminary experience on safety of regorafenib after sorafenib failure in recurrent hepatocellular carcinoma after liver transplantation.

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AM& A Migliavacca Center for Liver Disease, Division of Gastroenterology and Hepatology, University of Milan, Fondazione IRCCS Ca' Granda Maggiore Hospital, Milan, Italy.
Department of Internal Medicine I, University Medical Centre of the Johannes Gutenberg-University, Mainz, Germany.
Barcelona Clinic Liver Cancer Group, Liver Unit, Hospital Clínic, IDIBAPS, CIBERehd, University of Barcelona, Barcelona, Spain.
G.I. Surgery and Liver Transplantation Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
Service d'Hepatologie, Hopital Henri Mondor, Equipe 18, INSERM U955, Virus Immunité Cancer, Créteil, France.
Gastroenterology, Hepatology and Transplant Unit, Departement of Specialty and Transplant Medicine Azienda, Socio Sanitaria Territoriale Papa Giovanni XXIII, Bergamo, Italy.
Liver Unit, Hospital Universitario Central de Asturias, Oviedo, Spain.
Unidad de Hepatología y Trasplante Hepático, Hospital Aleman, Buenos Aires, Argentina.
Department of Internal Medicine III, Division of Gastroenterology & Hepatology, Medical University of Vienna, Vienna, Austria.
Hospital de Jerez, Jerez de la Frontera, Spain.
Liver Department, Gregorio Marañón Hospital, Madrid, Spain.
Sanatorio de la Trinidad Mitre, Buenos Aires, Argentina.
Latin American Liver Research Educational and Awareness Network (LALREAN), Hospital Universitario Austral, School of Medicine, Argentina, Buenos Aires, Argentina.
Department of Hepatology and Gastroenterology, Aarhus University Hospital, Aarhus C, Denmark.
Liver Transplant Unit, Liver Unit, Hospital Clínic, IDIBAPS, CIBERehd, University of Barcelona, Barcelona, Spain.
G. I. Surgery and Liver Trasplantation Unit, Fondazione IRCCS Istituto Nazionale dei Tumori and University of Milan, Milan, Italy.


Regorafenib is one option for second-line treatment of hepatocellular carcinoma (HCC), improving overall survival (OS) of sorafenib-tolerant patients who develop progression. We aim to evaluate the safety and outcomes of regorafenib as second-line treatment for HCC recurrence after liver transplantation (LT). This is a retrospective, multicenter, international study including regorafenib-treated LT patients (2015-2018), with analysis of baseline characteristics and evolutionary events during sorafenib/regorafenib treatment. Twenty-eight LT patients (57 years, 7% cirrhotics, 54% performance status 1) were included. Median time from LT to regorafenib initiation was 3.9 (1.1-18.5) years; median time on sorafenib was 11.3 (0.7-76.4) months and 14 (1-591) days from sorafenib discontinuation to regorafenib. During regorafenib (6.3 months), all patients had at least one adverse event (AE), the most common grade 3/4 AEs were fatigue (n = 7) and dermatological reaction (n = 5). While no liver rejection was observed, plasma levels of immunosuppressive drugs increased in five. Twenty-four patients developed progression (38% extrahepatic growth, 33% new extrahepatic lesions/vascular invasion). Median OS from regorafenib initiation was 12.9 (95% CI, 6.7-19.1) and 38.4 months (95% CI, 18.5-58.4) for the sorafenib initiation. This is the first study showing safety of regorafenib after LT, thus providing the rational of considering regorafenib in the clinical decision-making in sorafenib-tolerant patients with HCC recurrence after LT.


cancer/malignancy/neoplasia; chemotherapy; clinical research/practice; drug interaction; liver transplantation/hepatology; pharmacology; side effects


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