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Sorafenib in Advanced Hepatocellular Carcinoma
Open accessAbstract
BACKGROUND: No effective systemic therapy exists for patients with advanced hepatocellular carcinoma. A preliminary study suggested that sorafenib, an oral multikinase inhibitor of the vascular endothelial growth factor receptor, the platelet-derived growth factor receptor, and Raf may be effective in hepatocellular carcinoma. METHODS: In this multicenter, phase 3, double-blind, placebo-controlled trial, we randomly assigned 602 patients with advanced hepatocellular carcinoma who had not received previous systemic treatment to receive either sorafenib (at a dose of 400 mg twice daily) or placebo. Primary outcomes were overall survival and the time to symptomatic progression. Secondary outcomes included the time to radiologic progression and safety. RESULTS: At the second planned interim analysis, 321 deaths had occurred, and the study was stopped. Median overall survival was 10.7 months in the sorafenib group and 7.9 months in the placebo group (hazard ratio in the sorafenib group, 0.69; 95% confidence interval, 0.55 to 0.87; P<0.001). There was no significant difference between the two groups in the median time to symptomatic progression (4.1 months vs. 4.9 months, respectively, P=0.77). The median time to radiologic progression was 5.5 months in the sorafenib group and 2.8 months in the placebo group (P<0.001). Seven patients in the sorafenib group (2%) and two patients in the placebo group (1%) had a partial response; no patients had a complete response. Diarrhea, weight loss, hand-foot skin reaction, and hypophosphatemia were more frequent in the sorafenib group. CONCLUSIONS: In patients with advanced hepatocellular carcinoma, median survival and the time to radiologic progression were nearly 3 months longer for patients treated with sorafenib than for those given placebo. (ClinicalTrials.gov number, NCT00105443.)
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“In previously untreated patients with advanced hepatocellular carcinoma, the approved multikinase inhibitors lenvatinib and sorafenib have provided modest median overall survival benefits of 13•6 months (lenvatinib) and 12•3 months (sorafenib).5,6”
From Nivolumab plus ipilimumab versus lenvatinib or sorafenib as first-line treatment for unresectable hepatocellular carcinoma (CheckMate 9DW): an open-label, randomised, phase 3 trial (2025) · cites this paper as [5]
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“Multikinase inhibitors, including sorafenib and lenvatinib, are first-line treatment options for patients with unresectable hepatocellular carcinoma; however, they provide modest improvements in median overall survival (ranging from 12 months to 14 months), along with unsatisfactory safety outcomes.”
From Nivolumab plus ipilimumab versus lenvatinib or sorafenib as first-line treatment for unresectable hepatocellular carcinoma (CheckMate 9DW): an open-label, randomised, phase 3 trial (2025) · cites this paper as [5]
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“Over the past two decades, the development of effective systemic therapies has substantially improved the outcomes of patients with advanced-stage HCC2–6.”
From Adjuvant and neoadjuvant immunotherapies in hepatocellular carcinoma (2024) · cites this paper as [3]
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“The only FDA-approved drug for advanced HCC, sorafenib is well tolerated in cirrhotic patients (2) and inhibits several tyrosine kinases (e.g. VEGF, PDGFR, ERK/AKT, Ras, etc.), and their downstream oncogenic pathways (35).”
From Wnt-Pathway Activation in Two Molecular Classes of Hepatocellular Carcinoma and Experimental Modulation by Sorafenib (2012) · cites this paper as [2]
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“Of note, sorafenib performed exceptionally well in patients with non-viral HCCs, with a median OS reaching 18.1 months, considerably longer than that in the SHARP trial (10.7 months) or other sorafenib arms in recent phase three trials (13–15 months), which possibly cause the lack of comparative benefits for atezolizumab-bevacizumab in this subgroup despite preserved absolute benefits [27, 32, 33]”
From Etiology-Based Treatment for Unresectable/Advanced Hepatocellular Carcinoma: Focus on Viral Hepatitis and Metabolic Dysfunction-Associated Steatohepatitis (2025) · cites this paper as [32]
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Metadata
- Authors
- Llovet, J. M., Ricci, S., Mazzaferro, V., Hilgard, P., Gane, E., Blanc, J.-F., de Oliveira, A. C., Santoro, A., Raoul, J.-L., Forner, A., Schwartz, M., Porta, C., Zeuzem, S., Bolondi, L., Greten, T. F., Galle, P. R., Seitz, J.-F., Borbath, I., Häussinger, D., Giannaris, T., Shan, M., Moscovici, M., Voliotis, D., & Bruix, J.
- Affiliations
- Hospital Clínic de Barcelona (ES)
- University of Pisa (IT)
- Auckland City Hospital (NZ)
- Cliniques Universitaires Saint-Luc (BE)
- Université Européenne de Bretagne (FR)
- Centro de Investigación Biomédica en Red (ES)
- Goethe University Frankfurt (DE)
- Medizinische Hochschule Hannover (DE)
- Johannes Gutenberg University Mainz (DE)
- Aix-Marseille Université (FR)
- Bayer (United States) (US)
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2008-07-24
- Volume
- 359
- Issue
- 4
- Pages
- 378-390
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W1971837077
- Cited by
- 13,097
- References
- 66
- Citations by year
- 2026: 390 · 2025: 623 · 2024: 729 · 2023: 874 · 2022: 1003 · 2021: 1093 · 2020: 971 · 2019: 816 · 2018: 746 · 2017: 814 · 2016: 704 · 2015: 730 · 2014: 753 · 2013: 695 · 2012: 624
- FWCI
- 369.86
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Ghent University Academic Bibliography (Ghent University) (submittedVersion)
- Archivio istituzionale della ricerca (Alma Mater Studiorum Università di Bologna) (submittedVersion)
- Digital Access to Libraries (submittedVersion)
- Digital Access to Libraries (Université catholique de Louvain (UCL), l'Université de Namur (UNamur) and the Université Saint-Louis (USL-B)) (submittedVersion)
- VUBIR (Vrije Universiteit Brussel) (submittedVersion)
- Funders
- Falk Foundation
- Bristol-Myers Squibb
- Pfizer
- AstraZeneca
- GlaxoSmithKline
- Sanofi
- Exelixis
- Bayer HealthCare
- Eisai
- Merz Pharmaceuticals
- Ipsen
- Topics
- Health Sciences › Medicine › Hepatology › Hepatocellular Carcinoma Treatment and Prognosis
- Health Sciences › Medicine › Oncology › Colorectal Cancer Treatments and Studies
- Health Sciences › Medicine › Oncology › Renal cell carcinoma treatment
- Keywords
- sorafenib, hepatocellular carcinoma, multikinase inhibitor, VEGFR, PDGFR, Raf, overall survival, adverse effects, hand-foot skin reaction, hypophosphatemia, diarrhea, weight loss
- MeSH terms
- Sorafenib, Aged, Benzenesulfonates, Double-Blind Method, Female, Carcinoma, Hepatocellular, Humans, Liver Neoplasms, Male, Middle Aged, Neoplasm Staging, Niacinamide, Phenylurea Compounds, Pyridines, Proportional Hazards Models, Survival Analysis, Chemotherapy, Adjuvant, Disease Progression, Protein Kinase Inhibitors, raf Kinases
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