Table 2. Summary of Phase III trial results in the development of sorafenib monotherapy in hepatocellular carcinoma including safety and tolerability.
| Measure | SHARP trial (Llovet et al.) [11] | Asia-Pacific trial (Cheng et al.) [12] | |||
|---|---|---|---|---|---|
| Sorafenib group | Placebo group | Sorafenib group | Placebo group | ||
| Median TTP (months) | 5.5 | 2.8 | 2.8 | 1.4 | |
| Median TTSP (months) | 4.1 | 4.9 | 3.5 | 3.4 | |
| Median OS (months) | 10.7 | 7.9 | 6.5 | 4.2 | |
| Rate of discontinuation due to AEs (%) | 38 | 37 | 19.5 | 13.3 | |
| Level of response (%) | |||||
| Complete | 0 | 0 | 0 | 0 | |
| Partial | 2 | 1 | 3.5 | 1.3 | |
| Stable | 71 | 67 | 54 | 27.6 | |
| Most frequent drug-related AEs of grade ≥3 (%) | |||||
| Diarrhea | 8 | 2 | 6 | 0 | |
| HFSR | 8 | <1 | 10.7 | 0 | |
| Fatigue | 4 | <4 | 3.4 | 1.3 | |
AE: Adverse event; HFSR: Hand–foot skin reaction; OS: Overall survival; TTP: Time to progression; TTSP: Time to symptomatic progression.