REgorafenib after SORafenib in patients with hepatoCEllular carcinoma (RESORCE) was an international, multicenter, randomized (2:1), double-blind, placebo-controlled phase 3 trial that evaluated the efficacy and safety of STIVARGA in HCC patients with progression following sorafenib (N=573).
Baseline patient characteristics were similar between each arm1,2
STIVARGA (n=379) % | Placebo (n=194) % | |
---|---|---|
Sex | ||
Male | 88 | 88 |
Female | 12 | 12 |
Race | ||
White | 36 | 35 |
Asian‡ | 41 | 40 |
Black | 2 | 1 |
Other/Not reported | 21 | 24 |
Median age, years | 64 | 62 |
Eastern Cooperative Oncology Group performance status (ECOG PS) | ||
0 | 65 | 67 |
1 | 35 | 33 |
Macrovascular invasion (MVI) | 29 | 28 |
Extrahepatic disease (EHD) | 70 | 76 |
MVI and/or EHD | 80 | 84 |
Alpha-fetoprotein (AFP) ≥400 ng/mL | 43 | 45 |
Child-Pugh§ | ||
A | 98 | 97 |
B | 1 | 3 |
BCLC stage | ||
A | <1 | 0 |
B | 14 | 11 |
C | 86 | 89 |
Liver cirrhosis (investigator assessed) | 75 | 74 |
Etiology of HCCII | ||
Hepatitis B | 38 | 38 |
Alcohol use | 24 | 28 |
Hepatitis C | 21 | 21 |
Unknown | 17 | 16 |
Nonalcoholic steatohepatitis | 7 | 7 |
Other | 7 | 5 |
Duration of sorafenib treatment, months | 7.8 (4.2-14.5) | 7.8 (4.4-14.7) |
3.1-month median PFS achieved with STIVARGA vs 1.5 months with placebo
DCR, CR + PR + SD; ORR, CR + PR.