Table 1.
Results of phase III trials in second-line treatment for HCC.
| Study | Author (year) | Randomization | Child-Pugh score | Patients (n) | Survival (months) | Significance | TTP or PFS* (months) | Significance |
|---|---|---|---|---|---|---|---|---|
| BRISK-PS | Llovet et al.14 | Brivanib versus placebo | A-B7 | 263 versus 132 | 9.4 versus 8.2 | p=0.33 | 4.2 versus 2.7 | p=0.001 |
| EVOLVE-1 | Zhu et al.15 | Everolimus versus placebo | A | 362 versus 184 | 7.6 versus 7.3 | p=0.68 | 3.0 versus 2.6 | p=0.01 |
| REACH | Zhu et al.9 | Ramucirumab versus placebo | A | 283 versus 282 | 9.2 versus 7.6 | p=0.14 | 3.5 versus 2.6 | p<0.0001 |
| ADI-PEG 20 | Abou-Alfa et al.19 | ADI-PEG 20 versus placebo | A-B7 | 424 versus 211 | 7.8 versus 7.4 | p=0.88 | 2.6 versus 2.6* | p=0.075 |
| METIV-HCC | Rimassa et al.19 | Tivantinib versus placebo• | A | 226 versus 114 | 8.4 versus 8.1 | p=0.81 | 2.4 versus 3 | p=0.076 |
| RESORCE | Bruix et al.25 | Regorafenib versus placebo | A | 379 versus 194 | 10.6 versus 7.8 | <0.0001 | 3.9 versus 1.5 | <0.0001 |
| CELESTIAL | Abou-Alfa et al.35 | Cabozantinib versus placebo | A | 470 versus 237 | 10.2 versus 8.0 | p=0.005 | 5.2 versus 1.9* | p=0.001 |
| REACH-2 | Zhu et al.41 | Ramucirumab versus placebo♦ | A | 197 versus 95 | 8.5 versus 7.3 | p=0.0199 | 2.8 versus 1.6* | p<0.0001 |
•
In patients with baseline MET-high tumor.
♦
In patients with baseline α-fetoprotein ≥400 ng/mL.
*
TTP is not reported, only PFS is available.