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
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Summary
This summary is machine-generated.Sorafenib significantly improved overall survival and time to progression in patients with advanced hepatocellular carcinoma in the Asia-Pacific region. This targeted therapy demonstrated good tolerability, offering a new treatment option for this population.
Area Of Science
- Hepatocellular Carcinoma Research
- Oncology Drug Efficacy
- Asia-Pacific Clinical Trials
Background
- Hepatocellular carcinoma (HCC) is prevalent in the Asia-Pacific, often linked to chronic hepatitis B.
- Assessing novel therapies like sorafenib in this region is crucial.
Purpose Of The Study
- To evaluate the efficacy and safety of sorafenib in advanced HCC patients in the Asia-Pacific.
- To compare sorafenib versus placebo in a multinational, randomized, double-blind trial.
Main Methods
- Phase III, multinational, randomized, double-blind, placebo-controlled trial.
- 226 patients with advanced HCC received either sorafenib (400 mg twice daily) or placebo.
- Efficacy endpoints included overall survival, time to progression (TTP), and safety assessments.
Main Results
- Sorafenib showed a median overall survival of 6.5 months vs. 4.2 months for placebo (HR 0.68, p=0.014).
- Median TTP was 2.8 months with sorafenib versus 1.4 months with placebo (HR 0.57, p=0.0005).
- Common adverse events included hand-foot skin reaction, diarrhea, and fatigue; rarely leading to discontinuation.
Conclusions
- Sorafenib is effective and well-tolerated for advanced HCC in the Asia-Pacific region.
- Combined with SHARP trial data, sorafenib is a viable treatment option for advanced HCC.