Gerda Elisabeth Villadsen

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

Research output: Contribution to journal/Conference contribution in journal/Contribution to newspaperJournal articleResearchpeer-review

DOI

  • Massimo Iavarone, University of Milan
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  • Federica Invernizzi, University of Milan
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  • Carolin Czauderna, Johannes Gutenberg University Mainz
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  • Marco Sanduzzi-Zamparelli, Universitat Pompeu Fabra, Barcelona
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  • Sherrie Bhoori, IRCCS Fondazione Istituto Nazionale per lo studio e la cura dei tumori - Milano
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  • Giuliana Amaddeo, Hopital Henri Mondor
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  • Matteo A. Manini, Socio Sanitaria Territoriale Papa Giovanni XXIII
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  • Miguel F. López, Hospital Universitario Central de Asturias
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  • Margarita Anders, Hospital Alemán
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  • Matthias Pinter, Medical University of Vienna
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  • Maria J.B. Rodríguez, Hospital de Jerez
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  • Mario R. Cristóbal, Hospital Universitario Gregorio Marañón
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  • Gabriel A. Soteras, Sanatorio de la Trinidad
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  • Federico Piñero, Universidad Austral
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  • Gerda E. Villadsen
  • Arndt Weinmann, Johannes Gutenberg University Mainz
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  • Gonzalo Crespo, Universitat Pompeu Fabra, Barcelona
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  • Vincenzo Mazzaferro, IRCCS Fondazione Istituto Nazionale per lo studio e la cura dei tumori - Milano
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  • Helene Regnault, Hopital Henri Mondor
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  • Massimo De Giorgio, Socio Sanitaria Territoriale Papa Giovanni XXIII
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  • Maria L. González-Diéguez, Hospital Universitario Central de Asturias
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  • Maria F. Donato, University of Milan
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  • Maria Varela, Hospital Universitario Central de Asturias
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  • Marcus Alexander Wörns, Johannes Gutenberg University Mainz
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  • Jordi Bruix, Universitat Pompeu Fabra, Barcelona
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  • Pietro Lampertico, University of Milan
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  • Maria Reig, Universitat Pompeu Fabra, Barcelona

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.

Original languageEnglish
JournalAmerican Journal of Transplantation
Volume19
Issue11
Pages (from-to)3176-3184
Number of pages9
ISSN1600-6135
DOIs
Publication statusPublished - 2019

    Research areas

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

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