AI Article Synopsis
- Sorafenib is an oral multikinase inhibitor approved for advanced hepatocellular carcinoma (HCC), but its safety and effectiveness in Japanese patients had not been thoroughly evaluated prior to this study.
- The study involved 96 Japanese patients with advanced HCC, assessing efficacy and safety; results showed varying patient responses, with 12 patients showing partial response and a median survival time of 11.6 months.
- Key adverse effects leading to treatment discontinuation included liver dysfunction, hand-foot skin reaction, and diarrhea, and factors like serum levels of des-γ-carboxy prothrombin were identified as important for evaluating patient survival.
Article Abstract
Background: Sorafenib, an oral multikinase inhibitor, was approved for the treatment of advanced hepatocellular carcinoma (HCC), but has not been adequately evaluated for safety and effectiveness in Japanese patients with advanced HCC.
Aims: The purpose of this study was to prospectively assess the efficacy, safety, and risk factors for survival in patients with advanced HCC treated with sorafenib.
Methods: Between May 2009 and December 2010, 96 Japanese patients with advanced HCC (76 male, 20 female, mean age: 70.4 years) were treated with sorafenib. Eighty-eight patients had Child-Pugh class A, and 8 patients had Child-Pugh class B liver cirrhosis. Barcelona Clinic Liver Cancer stage B and C were found in 64 and 32 patients, respectively.
Results: Twelve patients demonstrated partial response to sorafenib therapy, 43 patients had stable disease, and 33 patients had progressive disease at the first radiologic assessment. The most frequent adverse events leading to discontinuation of sorafenib treatment were liver dysfunction (n = 8), hand-foot skin reaction (n = 7), and diarrhea (n = 4). The median survival time and time to progression were 11.6 and 3.2 months, respectively. By multivariate analysis, des-γ-carboxy prothrombin serum levels and duration of treatment were identified as independent risk factors for survival.
Conclusions: This study showed that sorafenib was safe and useful in Japanese patients with advanced HCC. In addition, this study demonstrated that sorafenib should be administered as a long-term treatment for advanced HCC regardless of therapeutic effect and dosage.
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| http://dx.doi.org/10.1159/000342650 | DOI Listing |
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