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Multicenter retrospective analysis of the safety and efficacy of regorafenib after progression on sorafenib in Korean patients with hepatocellular carcinoma

Published on Dec 7, 2018in Investigational New Drugs2.66
· DOI :10.1007/s10637-018-0707-5
Changhoon Yoo16
Estimated H-index: 16
(UOU: University of Ulsan),
Joong Won Park5
Estimated H-index: 5
+ 6 AuthorsHo Yeong Lim (SKKU: Sungkyunkwan University)
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Abstract
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 who received regorafenib under the NPP. Results A total of 49 patients entered into this NPP, and 40 patients received regorafenib in five Korean institutions. All but one patient received regorafenib as second-line therapy after progression on sorafenib, and 36 (90%) and 34 (85%) patients were classified as Child-Pugh A and BCLC stage C, respectively. The response rate was 10% (n = 4). The median progression-free survival (PFS) was 3.7 months (95% CI, 2.5–4.9 months), and the median overall survival (OS) was not reached. The 1 year OS rate was 54.6%. The time-to-progression (TTP) on prior sorafenib was significantly associated with PFS and OS. The most common grade 3–4 toxicities were hand-foot skin reaction (n = 3, 8%), hypertension (n = 2, 5%), and increased aspartate aminotransferase (n = 2, 5%). Conclusion Regorafenib was well-tolerated and effective in patients with advanced HCC who progressed on first-line sorafenib, with efficacy and safety outcomes consistent with those of the previous RESORCE trial. TTP on first-line sorafenib may predict the efficacy of subsequent regorafenib.
  • References (14)
  • Citations (0)
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References14
Newest
Published on Aug 1, 2018in Journal of Hepatology18.95
Richard S. Finn49
Estimated H-index: 49
(UCLA: University of California, Los Angeles),
Philippe Merle25
Estimated H-index: 25
+ 14 AuthorsChiara Caparello1
Estimated H-index: 1
Background & Aims The RESORCE trial showed that regorafenib improves overall survival (OS) in patients with hepatocellular carcinoma progressing during sorafenib treatment (hazard ratio [HR] 0.62, 95% confidence interval [CI] 0.50–0.78; p Methods In RESORCE, 573 patients were randomized 2:1 to regorafenib 160 mg/day or placebo for 3 weeks on/1 week off. Efficacy and safety were evaluated by last sorafenib dose. The time from the start of sorafenib to death was assessed. Time to progression (TTP)...
Published on Jul 5, 2018in The New England Journal of Medicine70.67
Ghassan K. Abou-Alfa29
Estimated H-index: 29
(MSK: Memorial Sloan Kettering Cancer Center),
Tim Meyer35
Estimated H-index: 35
(UCL: University College London)
+ 19 AuthorsYen Hsun Chen1
Estimated H-index: 1
(UCL: University College London)
Abstract Background Cabozantinib inhibits tyrosine kinases, including vascular endothelial growth factor receptors 1, 2, and 3, MET, and AXL, which are implicated in the progression of hepatocellul...
Published on Jul 1, 2018in Lancet Oncology35.39
Andrew X Zhu A X64
Estimated H-index: 64
(Harvard University),
Richard S. Finn49
Estimated H-index: 49
(UCLA: University of California, Los Angeles)
+ 56 AuthorsArndt Vogel37
Estimated H-index: 37
(Hochschule Hannover)
Summary Background Immune checkpoint blockade therapy has shown promising results in patients with advanced hepatocellular carcinoma. We aimed to assess the efficacy and safety of pembrolizumab in this patient population. Methods KEYNOTE-224 is a non-randomised, multicentre, open-label, phase 2 trial that is set in 47 medical centres and hospitals across ten countries. Eligible patients had pathologically confirmed hepatocellular carcinoma; had previously been treated with sorafenib and were eit...
Published on Dec 5, 2017in Oncotarget
Maria Kissel1
Estimated H-index: 1
,
Sandra Berndt1
Estimated H-index: 1
+ 7 AuthorsDieter Zopf7
Estimated H-index: 7
// Maria Kissel 1 , Sandra Berndt 2 , Lukas Fiebig 1 , Simon Kling 3 , Qunsheng Ji 4 , Qingyang Gu 4 , Tina Lang 5 , Frank-Thorsten Hafner 1 , Michael Teufel 6 and Dieter Zopf 2 1 Drug Discovery, Bayer AG, Wuppertal, Germany 2 Drug Discovery, Bayer AG, Berlin, Germany 3 Biochemistry, NMI Natural and Medicinal Sciences Institute, University of Tubingen, Reutlingen, Germany 4 Research Service Division, Oncology & Immunology Unit, WuXi AppTec Co. Ltd., Shanghai, China 5 Research & Clinical Sciences...
Published on Jun 1, 2017in The Lancet59.10
Anthony B. El-Khoueiry29
Estimated H-index: 29
,
Bruno Sangro56
Estimated H-index: 56
(University of Navarra)
+ 18 AuthorsTheodore H. Welling26
Estimated H-index: 26
(UM: University of Michigan)
Summary Background For patients with advanced hepatocellular carcinoma, sorafenib is the only approved drug worldwide, and outcomes remain poor. We aimed to assess the safety and efficacy of nivolumab, a programmed cell death protein-1 (PD-1) immune checkpoint inhibitor, in patients with advanced hepatocellular carcinoma with or without chronic viral hepatitis. Methods We did a phase 1/2, open-label, non-comparative, dose escalation and expansion trial (CheckMate 040) of nivolumab in adults (≥18...
Published on Jan 1, 2017in The Lancet59.10
Jordi Bruix91
Estimated H-index: 91
(University of Barcelona),
Shukui Qin27
Estimated H-index: 27
+ 21 AuthorsV. Breder3
Estimated H-index: 3
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...
Published on Aug 1, 2016in Liver International5.54
MasatoshiKudo72
Estimated H-index: 72
(Kindai University),
Riccardo Lencioni62
Estimated H-index: 62
(UniPi: University of Pisa)
+ 15 AuthorsLaura Ladrón de Guevara6
Estimated H-index: 6
Background & Aims Treatment approaches for hepatocellular carcinoma (HCC) vary across countries, but these differences and their potential impact on outcomes have not been comprehensively assessed. Data from the multinational GIDEON (Global Investigation of therapeutic DEcisions in HCC and Of its treatment with sorafeNib) registry evaluated differences in patient characteristics, practice patterns and outcomes in HCC across geographical regions in patients who received sorafenib. Methods GIDEON ...
Published on Jul 1, 2013in Molecular Cancer Therapeutics4.86
Lotfi Abou-Elkacem3
Estimated H-index: 3
(RWTH Aachen University),
Susanne Arns8
Estimated H-index: 8
(RWTH Aachen University)
+ 4 AuthorsWiltrud Lederle21
Estimated H-index: 21
(RWTH Aachen University)
The combination of target-specific drugs like bevacizumab with chemotherapeutics has improved treatment efficacy in advanced colorectal cancer (CRC). However, the clinical prognosis of metastatic CRCs is still poor, and novel drugs are currently assessed with respect to their efficacies in patients with CRCs. In a phase III study, the multikinase inhibitor regorafenib (BAY 73-4506) has recently been shown to prolong survival of patients with CRCs after standard therapies failed. In the present s...
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Published on Jun 6, 2019in Investigational New Drugs2.66
Sadahisa Ogasawara15
Estimated H-index: 15
(Chiba University),
Yoshihiko Ooka14
Estimated H-index: 14
(Chiba University)
+ 29 AuthorsEi Itobayashi5
Estimated H-index: 5
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 ...