Adult patients with solid cancers who are treated with sorafenib are at an increased risk of serious and fatal adverse events, according to a study published in Annals of Oncology.1

Researchers led by Bishal Gyawali, MD, of Nagoya University Hospital in Japan conducted a meta-analysis of 6797 patients with solid cancers from 12 phase 3 randomized controls trials that compared sorafenib alone or in combination with non-targeted chemotherapy against placebo or non-targeted chemotherapy alone.

Overall incidence was 26.4% for serious adverse events and 1.3% for fatal adverse events among patients treated with sorafenib.

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Treatment with sorafenib was found to significantly increase risk of both serious and fatal adverse events in contrast with control groups.

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It was also found that the association between sorafenib use and serious adverse event risk varied between cancer types and approval status. There was, however, no evidence of heterogeneity for fatal adverse events.

“This quantification of increased risks of serious adverse events and fatal adverse events will be important in considering the trade-off of sorafenib treatment during shared decision making,” the authors conclude.


  1. Gyawali B, Shimokata T, Ando M, et al. Risk of serious adverse events and fatal adverse events with sorafenib in patients with solid cancer: A meta-analysis of phase 3 randomized controlled trials. Ann Oncol. 2016 Oct 22. doi: 10.1093/annonc/mdw549 [Epub ahead of print]