Risk of fatal adverse events in cancer patients treated with sunitinib.

Sunitinib, a tyrosine kinase inhibitor, is widely used in several malignancies. However, the association between sunitinib administration and fatal adverse events (FAEs) is not completely clear. Here, to calculate the overall incidence and relative risks (RRs) of FAE induced by sunitinib, PubMed and Embase were searched from inception to September 2017 for phase III randomized controlled trials (RCTs). A total of 7470 patients with a variety of solid tumors from 12 trials were included in this study. The overall incidence of FAEs with sunitinib was 1.2% (95% CI: 0.7%-1.8%). Compared with control, the addition of sunitinib significantly increased the risk of FAEs (RR, 2.34; 95% CI, 1.34-4.09; P < 0.001). Trial sequential analysis demonstrated the cumulative z curve crossed the trial sequential monitoring boundary, established sufficient and conclusive evidence. Accordingly, further studies were unlikely to alter this conclusion. The association between sunitinib and FAEs varied significantly with treatment duration or treatment strategy, but not with tumor types or sunitinib dosage. The most common causes of FAEs was hemorrhage (26.9%). In conclusion, the use of sunitinib was associated with an increased risk of FAEs in patients with solid tumors.