Liver transplantation : official publication of the American Association for the Study of Liver Diseases and the International Liver Transplantation Society. 2021 Aug 13. doi: 10.1002/lt.26264 |
Regorafenib efficacy after sorafenib in patients with recurrent HCC after liver transplantation: a retrospective study. |
Iavarone M1, Invernizzi F2, Ivanics T3, Mazza S4, Zavaglia C5, Sanduzzi-Zamparelli M6, Fraile-López M7, Czauderna C8, Di Costanzo G9, Bhoori S10, Pinter M11, Manini MA12, Amaddeo G13, Yunquera AF14, Piñero F15, Blanco Rodríguez MJ16, Anders M17, Aballay Soteras G18, Villadsen GE19, Yoon PD20, Cesarini L21, Díaz-González Á22, González-Diéguez ML23, Tortora R24, Weinmann A25, Mazzaferro V26, Romero Cristóbal M27, Crespo G28, Regnault H29, De Giorgio M30, Varela M31, Prince R32, Scuddeler L33, Donato MF34, Wörns MA35, Bruix J36, Sapisochin G37, Lampertico P38, Reig M39 |
Abstract BACKGROUND AND AIM: Safety of regorafenib in hepatocellular carcinoma (HCC) recurrence after liver transplantation (LT) has been recently demonstrated. We aimed to assess the survival benefit of regorafenib compared to best supportive care (BSC) in LT-patients after sorafenib discontinuation. METHODS: This observational multicenter retrospective study included LT-patients with HCC-recurrence who discontinued first-line sorafenib. Group-1 was constituted by regorafenib-treated patients, while control group was selected among patients treated with best supportive care (BSC) due to unavailability of second-line options at the time of sorafenib discontinuation and who were sorafenib-tolerant progressors (group-2). Primary endpoint was overall survival (OS) of group-1 compared to group-2. Secondary endpoints were safety and OS of sequential treatment sorafenib+regorafenib/BSC. RESULTS: Among 132 LT-patients who discontinued sorafenib included in the study, 81 patients were sorafenib-tolerant: 36 received regorafenib (group-1) and 45 (group-2) received BSC. Overall, 24 (67%) patients died in group-1 and 40 (89%) in group-2: the median OS was significantly longer in group-1 than in group-2 (13.1 vs 5.5 months; p=0.002). Regorafenib treatment was an independent predictor of reduced mortality (HR 0.37, 95%CI 0.16-0.89, p=0.02). Median treatment duration with regorafenib was 7.0 (95%CI 5.5-8.5) months; regorafenib dose was reduced in 22 (61%) patients for adverse events and discontinued for tumor progression in 93%. The median OS calculated from sorafenib start was 28.8 months (95%CI: 17.6-40.1) in group-1 vs 15.3 months (95%CI: 8.8-21.7) in group-2 (p=0.002). CONCLUSIONS: Regorafenib is an effective second-line treatment after sorafenib in patients with HCC-recurrence after LT. |
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KEYWORDS: adverse event, hepatocellular carcinoma, mTOR, rejection, systemic treatment |
Publikations ID: 34388851 Quelle: öffnen |