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Supportive and palliative care

1325 - Risk of serious adverse events (SAEs) and fatal adverse events (FAEs) with sorafenib use in patients with solid cancers: a meta-analysis of phase 3 RCTs


08 Oct 2016


Supportive and palliative care


Bishal Gyawali


Annals of Oncology (2016) 27 (6): 497-521. 10.1093/annonc/mdw390


B. Gyawali, T. Shimokata, K. Honda, Y. Ando

Author affiliations

  • Clinical Oncology And Chemotherapy, Nagoya University, Graduate School of Medicine, 466-8550 - Nagoya/JP


Abstract 1325


Sorafenib is a commonly used vascular endothelial growth factor-tyrosine kinase inhibitor in a variety of cancers. There are concerns about the increased risk of SAEs and FAEs with sorafenib. We performed an up-to-date meta-analysis of all phase 3 randomized controlled trials (RCTs) of sorafenib to quantify the increased risk of SAEs and FAEs.


We carried out a systematic search on PubMed for studies published in English. Eligibility criteria included phase 3 RCTs of solid tumors comparing sorafenib, alone or in combination with non-targeted chemotherapy (Sorafenib arm) versus placebo or non-targeted chemotherapy (control arm). Data on SAEs and FAEs for both the arms were extracted from each study and pooled to determine the overall incidence, relative risks (RRs) and 95% Confidence Intervals (CIs).


Of 471 studies identified, a total of 12 phase 3 RCTs involving 6,797 solid cancer patients comparing sorafenib with control met the eligibility criteria and included in this meta-analysis. 8 RCTs compared sorafenib alone with a placebo and 4 RCTs compared sorafenib plus chemotherapy with chemotherapy plus placebo. The RCTs involved Hepatocellular carcinoma (HCC, n = 5), Melanoma (n= 2), non-small cell lung cancer ( n = 2), pancreatic cancer, renal cell carcinoma and thyroid cancer ( n = 1 each). The overall incidence of SAEs and FAEs with sorafenib were 24.5% (95% CI: 16.0%-35.5%) and 1.6% (95% CI: 0.7%- 3.3%) respectively. Compared with control, sorafenib use significantly increased the risk of both SAEs ( RR : 1.51, 95% CI: 1.20-1.92, P 


This meta-analysis of phase 3 RCTs demonstrates an increased risk of SAEs and FAEs with sorafenib use in patients with solid cancers. Special vigilance is recommended while using sorafenib in non-approved settings.

Clinical trial identification

Not applicable

Legal entity responsible for the study





Y. Ando: Sanofi, Torii, Mitsubishi Tanabe, Mochida, Chugai, Takeda, DaiichiSankyo, Kyowa Kirin, Eisai,Taiho, Nippon Kayaku, Yakult Honsya, Merck Serono, Hisamitsu, Ono, Eli Lilly, Pfizer, Novartis, Janssen, AstraZeneca, GSK,Terumo, Bayel, Boehringer Ingelheim,BMS. All other authors have declared no conflicts of interest.

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