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, lenvatinib and sorafenib have provided modest median overall survival benefits of 13.6 months and 12.3 months, respectively.
“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]
The Overall Survival section reports median overall survival of 10.7 months with sorafenib, not the attributed 12.3 months; placebo survival was 7.9 months. The trial did enroll patients with advanced hepatocellular carcinoma who had not received previous systemic treatment. This verdict concerns the sorafenib result attributed to this paper, not the lenvatinib result. (LLM, conf=0.90)
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Experimental — accuracy not yet measuredMultikinase inhibitors, including sorafenib and lenvatinib, provide modest improvements in median overall survival (ranging from 12 months to 14 months) along with unsatisfactory safety outcomes as first-line treatment for unresectable hepatocellular carcinoma.
“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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Experimental — accuracy not yet measuredEffective systemic therapies, especially immune-checkpoint inhibitors, have substantially improved outcomes for patients with advanced-stage hepatocellular carcinoma.
“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]
The Results in the Abstract report that sorafenib improved median overall survival from 7.9 to 10.7 months in patients with advanced hepatocellular carcinoma, supporting the cited sentence’s point that an effective systemic therapy improved outcomes. This 2008 trial does not establish a two-decade trend across multiple therapies or support the supplied claim’s emphasis on immune-checkpoint inhibitors, which the verbatim citing sentence does not mention. (LLM, conf=0.88)
Experimental — accuracy not yet measuredSorafenib is well tolerated in cirrhotic patients and inhibits several tyrosine kinases (e.g. VEGF, PDGFR, ERK/AKT, Ras, etc.) and their downstream oncogenic pathways.
“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]
Citation (2) is attached to the tolerability claim, not the mechanism claim cited to (35). The Safety section reports that adverse events were predominantly mild or moderate, but the Patients and Results sections show that the trial enrolled almost entirely people with Child-Pugh class A liver function. It does not establish tolerability across cirrhotic patients with more impaired liver function. (LLM, conf=0.84)
Experimental — accuracy not yet measuredIn IMbrave150, sorafenib performed exceptionally well in patients with non-viral HCCs, with median OS 18.1 months, considerably longer than in SHARP trial (10.7 months) or other sorafenib arms in recent phase 3 trials (13-15 months).
“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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“AST increased 20 (20) 4 (4) 5 (5) 11 (11) Proteinuria 20 (20) 9 (9) 7 (7) 4 (4) Asthenia 19 (19) 4 (4) 10 (10) 5 (5)”
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Vilgrain, V., Pereira, H., Assénat, E., Guiu, B., Ilonca, A. D., Pageaux, G., Sibert, A., Bouattour, M., Lebtahi, R., Allaham, W., et al. (2017) · The Lancet Oncology · doi:10.1016/s1470-2045(17)30683-6 · Cited by 833 · see citing works
Self-citationAntiangiogenic therapy in oncology: current status and future directions
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Tumour evolution in hepatocellular carcinoma
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The role of signaling pathways in the development and treatment of hepatocellular carcinoma
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Tremelimumab in combination with ablation in patients with advanced hepatocellular carcinoma
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Guidelines for the Diagnosis and Treatment of Hepatocellular Carcinoma (2019 Edition)
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- 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 › Pulmonary and Respiratory Medicine › 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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Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
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