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 safety and outcomes of regorafenib as second-line treatment for HCC-recurrence after liver transplantation (LT). This is a retrospective, multicentre, 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 1 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 5. Twenty-four patients developed progression (38% extra-hepatic growth, 33% new extra-hepatic 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.
Preliminary experience on safety of regorafenib after sorafenib failure in recurrent hepatocellular carcinoma after liver transplantation / M. Iavarone, F. Invernizzi, C. Czauderna, M. Sanduzzi-Zamparelli, S. Bhoori, G. Amaddeo, M.A. Manini, M. Fraile López, M. Anders, M. Pinter, M.J. Blanco Rodríguez, M. Romero Cristóbal, G. Aballay Soteras, F. Piñero, G.E. Villadsen, A. Weinmann, G. Crespo, V. Mazzaferro, H. Regnault, M. De Giorgio, M.L. González-Diéguez, M.F. Donato, M. Varela, M. Wörns, J. Bruix, P. Lampertico, M. Reig. - In: AMERICAN JOURNAL OF TRANSPLANTATION. - ISSN 1600-6135. - 19:11(2019 Nov 01), pp. 3176-3184. [10.1111/ajt.15551]
Preliminary experience on safety of regorafenib after sorafenib failure in recurrent hepatocellular carcinoma after liver transplantation
M. IavaronePrimo
;F. InvernizziSecondo
;M.A. Manini;V. Mazzaferro;P. LamperticoPenultimo
;
2019
Abstract
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 safety and outcomes of regorafenib as second-line treatment for HCC-recurrence after liver transplantation (LT). This is a retrospective, multicentre, 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 1 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 5. Twenty-four patients developed progression (38% extra-hepatic growth, 33% new extra-hepatic 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.File | Dimensione | Formato | |
---|---|---|---|
Iavarone_et_al-2019-American_Journal_of_Transplantation.pdf
accesso riservato
Tipologia:
Publisher's version/PDF
Dimensione
553.92 kB
Formato
Adobe PDF
|
553.92 kB | Adobe PDF | Visualizza/Apri Richiedi una copia |
Pubblicazioni consigliate
I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.