Sorafenib: A Review in Hepatocellular Carcinoma
1Springer, Private Bag 65901, Mairangi Bay 0754, Auckland, New Zealand. demail@springer.com.
Abstract:
Sorafenib (Nexavar®) is currently the only systemic agent approved for use in hepatocellular carcinoma (HCC). Its approval was based on the results of the pivotal SHARP and Sorafenib Asia-Pacific (AP) trials in Child-Pugh (CP) class A patients with advanced HCC, which showed significantly longer median overall survival (OS) and time to radiological progression (TTP) with sorafenib 400 mg twice daily than with placebo, with no significant between-group difference in the median time to symptomatic progression (TTSP). Subsequent results from real-world studies such as GIDEON also support the use of sorafenib in HCC, including in carefully selected CP class B patients, although the median OS achieved in these patients appears relatively short. Sorafenib has a well characterized tolerability and safety profile, with strategies available to prevent and manage adverse effects such as hand-foot skin reactions. In conclusion, sorafenib remains an important option for the treatment of HCC.
Insights
Sorafenib is the sole approved systemic treatment for advanced hepatocellular carcinoma (HCC), demonstrating improved survival in clinical trials. Real-world data support its use, with manageable side effects, making it a key option for HCC patients.
Area of Science:
- Hepatocellular Carcinoma Research
- Oncology Drug Efficacy
- Clinical Trial Analysis
Background:
- Sorafenib (Nexavar®) is the only approved systemic therapy for hepatocellular carcinoma (HCC).
- Its approval stems from the SHARP and Sorafenib Asia-Pacific trials in Child-Pugh class A patients.
- Real-world studies like GIDEON extend evidence to select Child-Pugh class B patients.
Purpose of the Study:
- To review the efficacy and safety of sorafenib in hepatocellular carcinoma treatment.
- To discuss its role in Child-Pugh class A and B patients.
- To highlight management strategies for sorafenib-related adverse events.
Main Methods:
- Analysis of pivotal clinical trials (SHARP, Sorafenib AP).
- Review of real-world evidence (GIDEON study).
- Evaluation of safety and tolerability data.
Main Results:
- Sorafenib significantly improved overall survival (OS) and time to radiological progression (TTP) versus placebo in advanced HCC (Child-Pugh A).
- No significant difference in time to symptomatic progression (TTSP) was observed.
- Real-world data confirm sorafenib's utility in select Child-Pugh B patients, though with shorter OS.
Conclusions:
- Sorafenib remains a crucial treatment option for advanced hepatocellular carcinoma.
- Its established safety profile and manageable adverse effects, like hand-foot skin reactions, support its continued use.
- Evidence supports sorafenib's application in both Child-Pugh A and carefully selected Child-Pugh B HCC patients.
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