1. Regorafenib Efficacy After Sorafenib in Patients With Recurrent Hepatocellular Carcinoma After Liver Transplantation:A Retrospective Study
- Author
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Matthias Pinter, Pietro Lampertico, Ainhoa Fernandez Yunquera, Gabriel Aballay Soteras, Miguel Fraile-López, Tommy Ivanics, Maria Reig, Massimo Iavarone, Álvaro Díaz-González, Maria Varela, Lucia Cesarini, Vincenzo Mazzaferro, Gerda Elisabeth Villadsen, Federica Invernizzi, Matteo Angelo Manini, Marcus A. Wörns, Maria Jose Blanco Rodríguez, Mario Romero Cristóbal, Helene Regnault, Giovanni Giuseppe Di Costanzo, Jordi Bruix, Sherrie Bhoori, Peter Daechul Yoon, Arndt Weinmann, Marco Sanduzzi-Zamparelli, Luigia Scudeller, Maria Francesca Donato, Gonzalo Sapisochin, Giuliana Amaddeo, Stefano Mazza, Carolin Czauderna, Gonzalo Crespo, Claudio Zavaglia, Massimo De Giorgio, Margarita Anders, María Luisa González-Diéguez, Rebecca Prince, R. Tortora, and Federico Piñero
- Subjects
Oncology ,Sorafenib ,medicine.medical_specialty ,Carcinoma, Hepatocellular ,Pyridines ,medicine.medical_treatment ,Antineoplastic Agents ,Liver transplantation ,chemistry.chemical_compound ,Regorafenib ,Internal medicine ,Clinical endpoint ,medicine ,Humans ,Retrospective Studies ,Transplantation ,Hepatology ,business.industry ,Phenylurea Compounds ,Liver Neoplasms ,Retrospective cohort study ,medicine.disease ,Recurrent Hepatocellular Carcinoma ,digestive system diseases ,Liver Transplantation ,Discontinuation ,chemistry ,Hepatocellular carcinoma ,Surgery ,business ,medicine.drug - 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.
- Published
- 2021
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