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Efficacy of Regorafenib in Hepatocellular Carcinoma Patients: A Systematic Review and Meta-Analysis.

Published on Dec 20, 2019in Cancers6.162
· DOI :10.3390/CANCERS12010036
Antonio Facciorusso17
Estimated H-index: 17
,
Mohamed A Abd El Aziz1
Estimated H-index: 1
(UA: University of Arizona)
+ 0 AuthorsRodolfo Sacco20
Estimated H-index: 20
Abstract
Regorafenib showed promising results as a second-line agent after sorafenib failure in hepatocellular carcinoma patients. The aim of this meta-analysis was to evaluate the efficacy and safety of regorafenib in hepatocarcinoma patients. A computerized bibliographic search was performed on the main databases. The primary outcome was overall survival. Secondary outcomes were progression-free survival, tumor response, and the adverse events rate. Outcomes were pooled through a random-effects model and summary estimates were expressed in terms of median and 95% confidence interval or rates, as appropriate. One randomized-controlled trial and seven non-randomized studies with 809 patients were included. The great majority of recruited patients were in Child-Pugh A and ECOG 0 stage. Median overall survival was 11.08 months (9.46–12.71) and sensitivity analyses confirmed this finding, with a median survival ranging from 10.2 to 13.8 months. Duration of regorafenib therapy was 3.58 months, whereas median progression-free survival was 3.24 months (2.68–3.86). The pooled objective response rate was 10.1% (7.8%–12.5%) while the disease control rate was 65.5% (61.3%–69.7%) with no evidence of heterogeneity (I2 = 0%; Diarrhea, fatigue, and hand-foot skin reaction were the most frequent adverse events. The current meta-analysis shows that regorafenib represents a valuable and relatively safe therapeutic option in intermediate/advanced hepatocellular carcinomapatients who progress on sorafenib.
  • References (28)
  • Citations (2)
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References28
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#1Sadahisa Ogasawara (Chiba University)H-Index: 16
#2Yoshihiko Ooka (Chiba University)H-Index: 15
Last. Naoya Kato (Chiba University)H-Index: 8
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Background Conversion from sorafenib to regorafenib is primarily an evidence-based treatment strategy in patients with advanced hepatocellular carcinoma (HCC). This study aimed to assess the safety and efficacy of sequential therapy with sorafenib and regorafenib in patients with advanced HCC by analysis of outcomes in clinical practice with the aim to complement phase III findings. Methods The medical records of patients with advanced HCC receiving regorafenib were retrieved to collect data on ...
5 CitationsSource
#1Wan WangH-Index: 2
#2Kaoru TsuchiyaH-Index: 25
Last. Namiki IzumiH-Index: 48
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Background: We aimed to explore the relative dose intensity (RDI) and post-regorafenib treatments in regorafenib therapy. Methods: The medical records of 38 patients treated with regorafenib between July 2017 and June 2019 at our institution were collected. The RDI of regorafenib for the first month (1M-RDI) was calculated. Results: The overall survival (OS) and progression-free survival (PFS) were 12.4 and 3.7 months. The objective response rate and disease control rate were 13.2% and 71.1%. Th...
3 CitationsSource
#1Teiji Kuzuya (Nagoya University)H-Index: 17
#2Masatoshi Ishigami (Nagoya University)H-Index: 24
Last. Mitsuhiro Fujishiro (Nagoya University)H-Index: 1
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AIM: This study aimed to investigate the clinical characteristics and outcomes of candidates for second-line therapy, including regorafenib and ramucirumab, for advanced hepatocellular carcinoma (HCC) after sorafenib treatment. METHODS: Of 122 patients, 103 were radiologically confirmed as progressive disease (PD) (sorafenib-refractory group), and 19 discontinued sorafenib therapy due to adverse events prior to radiologic PD (sorafenib-intolerant group). Patients in the sorafenib-refractory grou...
1 CitationsSource
#1Massimo Iavarone (University of Milan)H-Index: 24
#2F. Invernizzi (University of Milan)H-Index: 5
Last. María Reig (University of Barcelona)H-Index: 26
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: 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 s...
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#1Changhoon Yoo (UOU: University of Ulsan)H-Index: 16
#2Joong Won ParkH-Index: 24
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Background The pivotal RESORCE trial showed that regorafenib was effective as second-line therapy for patients with advanced HCC who progressed on first-line sorafenib. Real-world data are needed to assess clinical outcomes and adverse events in the setting of daily practice. Methods Between April 2017 and August 2017, the Named Patient Program (NPP) was activated to provide controlled, pre-approval access of regorafenib in Korea. This analysis is a multicenter retrospective study of patients wh...
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#1Carla Rognoni (Bocconi University)H-Index: 13
#2Oriana Ciani (University of Exeter)H-Index: 15
Last. Rosanna Tarricone (Bocconi University)H-Index: 20
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Background Trans-arterial radio-embolization (TARE) is an emerging treatment for the management of hepatocellular carcinoma (HCC). TARE may compete with systemic chemotherapy, sorafenib, in intermediate stage patients with prior chemoembolization failure or advanced patients with tumoral macrovascular invasion with no extra-hepatic spread and good liver function. We performed a budget impact analysis (BIA) evaluating the expected changes in the expenditure for the Italian Healthcare Service with...
1 CitationsSource
#1Peter R. GalleH-Index: 89
#2Alejandro Forner (European Organisation for Research and Treatment of Cancer)H-Index: 30
Last. Valérie VilgrainH-Index: 72
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Summary Liver cancer is the fifth most common cancer and the second most frequent cause of cancer-related death globally. Hepatocellular carcinoma represents about 90% of primary liver cancers and constitutes a major global health problem. The following Clinical Practice Guidelines will give up-to-date advice for the clinical management of patients with hepatocellular carcinoma, as well as providing an in-depth review of all the relevant data leading to the conclusions herein.
1,896 CitationsSource
#1Julie K. Heimbach (Mayo Clinic)H-Index: 45
#2Laura KulikH-Index: 48
Last. Jorge A. Marrero (UTSW: University of Texas Southwestern Medical Center)H-Index: 51
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Author(s): Heimbach, JK; Kulik, LM; Finn, RS; Sirlin, CB; Abecassis, MM; Roberts, LR; Zhu, AX; Murad, MH; Marrero, JA
463 CitationsSource
#1Jordi Bruix (University of Barcelona)H-Index: 93
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Summary Background There are no systemic treatments for patients with hepatocellular carcinoma (HCC) whose disease progresses during sorafenib treatment. We aimed to assess the efficacy and safety of regorafenib in patients with HCC who have progressed during sorafenib treatment. Methods In this randomised, double-blind, parallel-group, phase 3 trial done at 152 sites in 21 countries, adults with HCC who tolerated sorafenib (≥400 mg/day for ≥20 of last 28 days of treatment), progressed on sorafe...
632 CitationsSource
#1Carla Rognoni (Bocconi University)H-Index: 13
#2Oriana Ciani (University of Exeter)H-Index: 15
Last. Vincenzo MazzaferroH-Index: 11
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// Carla Rognoni 1 , Oriana Ciani 1,2 , Silvia Sommariva 1 , Antonio Facciorusso 3 , Rosanna Tarricone 1,4 , Sherrie Bhoori 3 and Vincenzo Mazzaferro 3 1 Centre for Research on Health and Social Care Management (CERGAS), Bocconi University, Milan, Italy 2 Evidence Synthesis and Modelling for Health Improvement (ESMI), University of Exeter Medical School, South Cloisters, St Luke’s Campus, Exeter, UK 3 Department of Surgery, Liver Surgery, Transplantation and Gastroenterology, Istituto Nazionale ...
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Cited By2
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#2Bernhard Scheiner (Medical University of Vienna)H-Index: 7
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BACKGROUND: Hepatocellular carcinoma (HCC) is one of the most lethal cancers. After many years of stagnation, there are now several systemic treatments available for patients with HCC. AIM: To analyse the feasibility and efficacy of sequential systemic treatments in patients with HCC in clinical practice. METHODS: In this multicentre study, patients who were treated with novel systemic therapies for HCC between 2014 and 2019 at two referral centres, Hannover Medical School, Germany, and Medical ...
Source
#1Antonio Facciorusso (University of Foggia)H-Index: 17
#2Irene BargelliniH-Index: 24
Last. Rodolfo Sacco (University of Foggia)H-Index: 20
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Background: Adjuvant sorafenib may enhance the efficacy of transarterial radioembolization with yttrium-90 in hepatocellular carcinoma patients. The aim of this study is to assess the efficacy and safety of radioembolization plus sorafenib in comparison to radioembolization alone. Methods: Out of 175 hepatocellular carcinoma (HCC) patients treated with radioembolization between 2011 and 2018, after propensity score matching, two groups were compared: a group of 45 patients that underwent radioem...
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