Table 1.
Study Name | Design | Met Primary Endpoint(s) | Patients (n) | TTP/PFS (Months) | mOS (Months) |
---|---|---|---|---|---|
1st Line Setting | |||||
SHARP | Sorafenib vs. placebo |
Yes | Sorafenib (299) Placebo (303) |
5.5 vs. 2.8 HR = 0.58 95% CI: 0.45–0.74 p < 0.001 |
10.7 vs. 7.9 HR = 0.69 95% CI: 0.55–0.87 p < 0.001 |
Asian-Pacific | Sorafenib vs. placebo |
Yes | Sorafenib (150) Placebo (76) |
2.8 vs. 1.4 HR = 0.57 95% CI: 0.42–0.79 p < 0.001 |
6.5 vs. 4.2 HR = 0.68 95% CI: 0.50–0.93 p = 0.014 |
SUN1170 | Sunitinib vs. sorafenib |
No | Sunitinib (530) Sorafenib (544) |
4.1 vs. 3.8 HR = 1.13 95% CI: 0.98–1.31 p = 0.308 |
7.9 vs. 10.2 HR = 1.30 95% CI: 1.13–1.50 p = 0.001 |
BRISK-FL | Brivanib vs. sorafenib |
No | Brivanib (577) Sorafenib (578) |
4.2 vs. 4.1 HR = 1.01 95% CI: 0.88–1.16 p = 0.853 |
9.5 vs. 9.9 HR = 1.06 95% CI: 0.93–1.22 p = 0.373 |
LIGHT | Linifanib vs. sorafenib |
No | Linifanib (514) Sorafenib (521) |
5.4 vs. 4.0 HR = 0.76 95% CI: 0.64–0.90 p = 0.001 |
9.1 vs. 9.8 HR = 1.04 95% CI: 0.90–1.22 p = NS |
SEARCH | Sorafenib +/− erlotinib |
No | Sorafenib + Erlotinib (362) Sorafenib + placebo (358) |
3.2 vs. 4.0 HR = 1.135 95% CI: 0.94–1.37 p = 0.180 |
9.5 vs. 8.5 HR = 0.929 95% CI: 0.78–1.11 p = 0.408 |
CALGB80802 | Sorafenib +/− doxorubicin |
No | Sorafenib + Doxorubicin (180) Sorafenib + Placebo (176) |
3.6 vs. 3.2 * HR = 0.90 95% CI: 0.72–1.20 p = NS |
9.3 vs. 10.5 HR = 1.06 95% CI: 0.80–1.40 p = NS |
REFLECT | Lenvatinib vs. sorafenib |
Yes | Lenvatinib (478) Sorafenib (476) |
8.9 vs. 3.7 HR = 0.63 95% CI: 0.53–0.73 p < 0.0001 |
13.6 vs. 12.3 HR = 0.92 95% CI: 0.79–1.06 p = NS |
SARAH | Y90 vs. sorafenib |
No | Y90 (237) Sorafenib (222) |
4.1 vs. 3.7 * HR = 1.03 95% CI: 0.85–1.25 p = 0.760 |
8.0 vs. 9.9 HR = 1.15 95% CI: 0.94–1.14 p = 0.180 |
SIRveNIB | Y90 vs. sorafenib |
No | Y90 (182) Sorafenib (178) |
6.1 vs. 5.4 HR = 0.88 95% CI: 0.70–1.10 p = 0.290 |
8.8 vs. 10.0 HR = 1.10 95% CI: 0.90–1.40 p = 0.360 |
* Progression-Free Survival (PFS); NS: not significant.