摘要
Sorafenib is a new treatment indicated for patients with advanced renal cell carcinoma who have failed prior cytokine-based therapy or are considered unsuitable for such therapy. Although treatment with sorafenib under ‘ideal trial conditions’ has been extensively studied, registration and reimbursement authorities are also interested in the behavior of sorafenib in real-life practice. This study aims to conduct a literature review of the dosage and treatment duration;safety, tolerability and effectiveness;costs and cost-effectiveness of sorafenib in routine clinical care. Studies were identified by searching PubMed, Embase, Centre for Reviews and Dissemination databases, Cochrane Database of Systematic Reviews, and EconLit up to November 2010. The literature search included articles published in peer-reviewed journals, congress abstracts, and internal studies of Bayer Schering Pharma. Eight studies were included. An open-label study observed stable disease for at least eight weeks in 80% of patients. The most common drug-related adverse events were hand-foot skin reaction, rash, hypertension, and fatigue. Although treatment with sorafenib led to fewer dose reductions, it was also associated with a shorter treatment duration, less time to pro-gression and a shorter survival time as compared to sunitinib. Monthly health care costs were lower with sorafenib as compared to sunitinib. A post-marketing surveillance study showed that patients rated the tolerability and effectiveness of sorafenib as very good, good or sufficient. In conclusion, the current evidence is too limited to derive conclusions and existing studies suffer from methodological shortcomings.
Sorafenib is a new treatment indicated for patients with advanced renal cell carcinoma who have failed prior cytokine-based therapy or are considered unsuitable for such therapy. Although treatment with sorafenib under ‘ideal trial conditions’ has been extensively studied, registration and reimbursement authorities are also interested in the behavior of sorafenib in real-life practice. This study aims to conduct a literature review of the dosage and treatment duration;safety, tolerability and effectiveness;costs and cost-effectiveness of sorafenib in routine clinical care. Studies were identified by searching PubMed, Embase, Centre for Reviews and Dissemination databases, Cochrane Database of Systematic Reviews, and EconLit up to November 2010. The literature search included articles published in peer-reviewed journals, congress abstracts, and internal studies of Bayer Schering Pharma. Eight studies were included. An open-label study observed stable disease for at least eight weeks in 80% of patients. The most common drug-related adverse events were hand-foot skin reaction, rash, hypertension, and fatigue. Although treatment with sorafenib led to fewer dose reductions, it was also associated with a shorter treatment duration, less time to pro-gression and a shorter survival time as compared to sunitinib. Monthly health care costs were lower with sorafenib as compared to sunitinib. A post-marketing surveillance study showed that patients rated the tolerability and effectiveness of sorafenib as very good, good or sufficient. In conclusion, the current evidence is too limited to derive conclusions and existing studies suffer from methodological shortcomings.
