Efficacy and safety of sorafenib in patients in the Asia-Pacific region with advanced hepatocellular carcinoma: a phase III randomised, double-blind, placebo-controlled trial
Abstract
Background Most cases of hepatocellular carcinoma occur in the Asia-Pacific region, where chronic hepatitis B infection is an important aetiological factor. Assessing the efficacy and safety of new therapeutic options in an Asia-Pacific population is thus important. We did a multinational phase III, randomised, double-blind, placebo-controlled trial to assess the efficacy and safety of sorafenib in patients from the Asia-Pacific region with advanced (unresectable or metastatic) hepatocellular carcinoma.Methods Between Sept 20, 2005, and Jan 31, 2007, patients with hepatocellular carcinoma who had not received previous systemic therapy and had Child-Pugh liver function class A, were randomly assigned to receive either oral sorafenib (400 mg) or placebo twice daily in 6-week cycles, with efficacy measured at the end of each 6-week period. Eligible patients were stratified by the presence or absence of macroscopic vascular invasion or extrahepatic spread (or both), Eastern Cooperative Oncology Group performance status, and geographical region. Randomisation was done centrally and in a 2:1 ratio by means of an interactive voice-response system. There was no predefined primary endpoint; overall survival, time to progression (TTP), time to symptomatic progression (TTSP), disease control rate (DCR), and safety were assessed. Efficacy analyses were done by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00492752.Findings 271 patients from 23 centres in China, South Korea, and Taiwan were enrolled in the study. Of these, 226 patients were randomly assigned to the experimental group (n=150) or to the placebo group (n=76). Median overall survival was 6.5 months (95% CI 5.56-7.56) in patients treated with sorafenib, compared with 4.2 months (3.75-5.46) in those who received placebo (hazard ratio [HR] 0.68 [95% CI 0.50-0.93]; p=0.014). Median TTP was 2.8 months (2.63-3.58) in the sorafenib group compared with 1.4 months (1.35-1.55) in the placebo group (HR 0.57 [0.42-0.79]; p=0.0005). The most frequently reported grade 3/4 drug-related adverse events in the 149 assessable patients treated with sorafenib were hand-foot skin reaction (HFSR; 16 patients [10.7%]), diarrhoea (nine patients [6.0%]), and fatigue (five patients [3.4%]). The most common adverse events resulting in dose reductions were HFSR (17 patients [11.4%]) and diarrhoea (11 patients [7.4%]); these adverse events rarely led to discontinuation.Interpretation Sorafenib is effective for the treatment of advanced hepatocellular carcinoma in patients from the Asia-Pacific region, and is well tolerated. Taken together with data from the Sorafenib Hepatocellular Carcinoma Assessment Randomised Protocol (SHARP) trial, sorafenib seems to be an appropriate option for the treatment of advanced hepatocellular carcinoma.
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Sorafenib has an objective response rate of less than 5% in advanced-stage HCC.
“The oral multi-kinase inhibitor, sorafenib, is the standard systemic therapeutic option for advanced-stage HCC and has an objective response rate (ORR) of less than 5% [2].”
From Gut microbiome affects the response to anti-PD-1 immunotherapy in patients with hepatocellular carcinoma (2019) · cites this paper as [2]
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- Authors
- Cheng, A.-L., Kang, Y.-K., Chen, Z., Tsao, C.-J., Qin, S., Kim, J. S., Luo, R., Feng, J., Ye, S., Yang, T.-S., Xu, J., Sun, Y., Liang, H., Liu, J., Wang, J., Tak, W. Y., Pan, H., Burock, K., Zou, J., Voliotis, D., & Guan, Z.
- Affiliations
- National Taiwan University Hospital (TW)
- Asan Medical Center (KR)
- First Affiliated Hospital of Anhui Medical University (CN)
- Chi Mei Medical Center (TW)
- 81th Hospital of PLA (CN)
- Korea University Guro Hospital (KR)
- Nanfang Hospital (CN)
- Jiangsu Cancer Hospital (CN)
- Chang Gung Memorial Hospital (TW)
- Academy of Military Medical Sciences (CN)
- Chinese Academy of Medical Sciences & Peking Union Medical College (CN)
- Army Medical University (CN)
- First Affiliated Hospital of Dalian Medical University (CN)
- Shanghai Changzheng Hospital (CN)
- Kyungpook National University Hospital (KR)
- Sir Run Run Shaw Hospital (CN)
- Bayer (Germany) (DE)
- Bayer (China) (CN)
- Bayer (United States) (US)
- Sun Yat-sen University (CN)
- Corresponding author
- Cheng, Ann-Lii
- ORCID
- Venue
- The Lancet Oncology
- Publisher
- Elsevier BV
- Published
- 2009-01
- Volume
- 10
- Issue
- 1
- Pages
- 25-34
- ISSN
- 1470-2045 (ISSN-L)
- OpenAlex
- W1994193851
- Cited by
- 5,832
- References
- 40
- Citations by year
- 2026: 92 · 2025: 242 · 2024: 300 · 2023: 380 · 2022: 413 · 2021: 480 · 2020: 470 · 2019: 390 · 2018: 384 · 2017: 394 · 2016: 351 · 2015: 375 · 2014: 376 · 2013: 356 · 2012: 293
- FWCI
- 129.73
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- The Lancet Oncology (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Bayer HealthCare
- Topics
- Health Sciences › Medicine › Hepatology › Hepatocellular Carcinoma Treatment and Prognosis
- Health Sciences › Medicine › Oncology › Colorectal Cancer Treatments and Studies
- Health Sciences › Medicine › Epidemiology › Hepatitis B Virus Studies
- Keywords
- sorafenib, hepatocellular carcinoma, advanced liver cancer, oral tyrosine kinase inhibitor, overall survival, time to progression, disease control rate, safety, chronic hepatitis B, liver metastasis, China, South Korea, Taiwan, macrovascular invasion, extrahepatic spread, ECOG performance status
- MeSH terms
- Sorafenib, Adult, Aged, Aged, 80 and over, Antineoplastic Agents, Benzenesulfonates, Cost-Benefit Analysis, Double-Blind Method, Female, Carcinoma, Hepatocellular, Humans, Liver Neoplasms, Male, Middle Aged, Niacinamide, Phenylurea Compounds, Pyridines, Protein Kinase Inhibitors
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