Eleven trials were included in the review (n=4,883; range 22 to 2,502), including three randomised controlled trials (RCTs), two randomised discontinuation trials, five single arm phase II trials and one expanded access program trial.
Overall, the incidence of all-grade HFSR was 33.8 per cent (95% CI: 24.5, 44.7; n=3,797 evaluable patients). Incidence of grade III HFSR was 8.9 per cent (95% CI: 7.3, 10.7; n=4,020 evaluable patients).
Incidence of all-grade HFSR in patients with renal cell carcinoma was 42 per cent (95% CI: 24.9, 61.3; n=3252 evaluable patients). Incidence of all-grade HFSR in patients with non-renal cell carcinoma malignancies was 27.6 per cent (95% CI: 20.2, 36.4; n=545 evaluable patients).
The incidence of grade III HFSR in patients with renal cell carcinoma was 8.9 per cent (95% CI: 6.3, 12.3; n=3252 evaluable patients). The incidence of grade III HFSR in patients with non-renal cell carcinoma malignancies was 9.1 per cent (95% CI: 7.2, 11.3; n=545 evaluable patients).
All-grade HFSR was significantly more common in patients with renal cell carcinoma than those with non-renal cell carcinoma malignancies (RR 1.52, 95% CI: 1.32, 1.75, p<0.001), but there was no difference in the incidence of grade III HFSR.
The incidence of HFSR in patients receiving sorafenib was significantly greater than for those receiving placebo or interferon in the meta-analysis of the three RCTs (RR 6.6, 95% CI: 3.7, 11.7, p<0.001).