Table 1. Lists a summary of the TKI’s that are FDA approved in advanced HCC.
Trial name | Author | No. of patients | Study arm | ECOG | Child-Pugh score | BCLC stage | Primary endpoint |
---|---|---|---|---|---|---|---|
SHARP | Llovet et al. (5) | 602 | Sorafenib vs. placebo (first-line setting) | 0 to 2 | A | B | OS: 10.7 vs. 7.9 months; hazard ratio (HR) =0.69; P<0.001; TTP: 4.1 vs. 4.9 months, P=0.77 |
REFLECT | Kudo et al. (8) | 954 | Lenvantinib vs. sorafenib (first-line setting) | 0 or 1 | A | B or C | OS: lenvatinib 13.6 months (95% CI: 12.1–14.9) vs. sorafenib (12.3 months, 95% CI: 10.4–13.9) (HR =0.92, 95% CI: 0.79–1.06) |
CELESTIAL | Abou-Alfa et al. (9) | 707 | Cabozantinib vs. placebo (second-line setting) | 0 or 1 | A | OS: cabozantinib 10.2 vs. 8.0 months with placebo (HR =0.76; 95% CI: 0.63–0.92; P=0.005) | |
RESORCE | Bruix et al. (10) | 567 | Regorafenib vs. placebo (second-line setting) | 0 or 1 | A | B or C | OS: 10.6 months (95% CI: 9.1–12.1) for regorafenib vs. 7.8 months (6.3–8.8) for placebo, HR =0.63 (95% CI: 0.50–0.79; P<0.0001) |
TKI, tyrosine kinase inhibitors; HCC, hepatocellular carcinoma; OS, overall survival; HR, hazard ratio.