Key result
Sorafenib increases fatal adverse events ~77% vs. control in cancer patients.
Why the study?
Does sorafenib increase the risk of fatal adverse events in patients with cancer?
Meta-Analysis (n=5,546)
Does sorafenib increase the risk of fatal adverse events in patients with cancer?
Sorafenib is associated with a significantly increased risk of fatal adverse events in cancer patients, particularly those with lung and renal cancer.
Sorafenib warrants closer monitoring or risk-benefit reassessment in cancer; confirms elevated fatal event risk particularly in lung and renal disease.
BACKGROUND: Fatal adverse events (FAEs) have been reported with sorafenib, a vascular endothelial growth factor receptor kinase inhibitor (VEGFR TKI). We here performed an up-to-date and detailed meta-analysis to determine the overall risk of FAEs associated with sorafenib. METHODS: Databases, including PubMed, Embase and Web of Science, and abstracts presented at the American Society of Clinical Oncology annual meetings were searched to identify relevant studies. Eligible studies included randomized controlled trials evaluating sorafenib effects in patients with all malignancies. Summary incidence rates, relative risks (RRs), and 95% confidence intervals (CIs) were calculated for FAEs. In addition, subgroup analyses were performed according to tumor type and therapy regimen. RESULTS: 13 trials recruiting 5,546 patients were included in our analysis. The overall incidence of FAEs with sorafenib was 1.99% (95%CI, 0.98-4.02%). Patients treated with sorafenib had a significantly increased risk of FAEs compared with patients treated with control medication, with an RR of 1.77 (95%CI 1.25-2.52, P=0.001). Risk varied with tumour type, but appeared independent of therapy regimen. A significantly increased risk of FAEs was observed in patients with lung cancer (RR 2.26; 95% CI 1.03-4.99; P= 0.043) and renal cancer (RR 1.84; 95% CI 1.15-2.94; P= 0.011). The most common causes of FAEs were hemorrhage (8.6%) and thrombus or embolism (4.9%). CONCLUSIONS: It is important for health care practitioners to be aware of the risks of FAEs associated with sorafenib, especially in patients with renal and lung cancer.
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Zhang et al. (2013) conducted a meta-analysis in Cancer (n=5,546). Sorafenib vs. Placebo or best supportive care was evaluated on Fatal adverse events (FAEs) (RR 1.77, 95% CI 1.25-2.52, p=0.001). Sorafenib significantly increased the risk of fatal adverse events compared to control medication in patients with cancer (RR 1.77).
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