Table 1.

Patient demographics and baseline characteristics

ParameterOnce-daily dosing (n = 106)Twice-daily dosing (n = 9)All patients (n = 115)
Age, y
 Median (range), y60 (18–85)74 (63–81)61 (18–55)
Gender, n (%)
 Male83 (78)5 (56)88 (77)
Etiology, n (%)
 Nonviral29 (27)3 (33)32 (28)
 HBV51 (48)2 (22)53 (46)
 HCV15 (14)2 (22)17 (15)
 Other/unknown11 (10)2 (22)13 (11)
Metastatic disease, n (%)86 (81)5 (56)91 (79)
Number of sites, n (%)
 153 (50)4 (44)57 (50)
 222 (21)022 (19)
 35 (5)1 (11)6 (5)
 46 (6)06 (5)
Largest target lesion, n (%)
 ≤5 cm69 (65)4 (44)73 (63)
 >5–≤10 cm27 (25)5 (56)32 (28)
 >10–≤15 cm6 (6)06 (5)
 >15 cm4 (4)04 (3)
FGF19 IHC, n (%)
 Positive (IHC ≥ 1%)72 (68)0 (0)72 (63)
 Negative (IHC < 1%)29 (27)6 (67)35 (30)
 Unknown5 (5)3 (33)8 (7)
FGF19 FISH, n (%)
 Positive8 (8)1 (11)9 (8)
Median prior therapy (range)1 (0–5)1 (0–2)1 (0–5)
Prior therapy type, n (%)
 Surgical resection82 (77)4 (44)86 (75)
 Radiotherapy32 (30)2 (22)34 (30)
 TACE/embolization56 (53)3 (33)59 (51)
 Immunotherapy30 (28)1 (11)31 (27)
  Nivolumab19 (18)0 (0)19 (17)
 Kinase inhibitor91 (86)6 (67)97 (84)
  Sorafenib90 (85)6 (67)96 (83)
 Systemic therapy97 (92)6 (67)103 (90)
Median duration of prior sorafenib (range), mo4 (0.03–31.11)1 (0.03–20.11)4 (0.03–31.11)
FGF19 IHC statusPositiven = 72Negative/unknown n = 34Positive n = 0Negative/unknownn = 9Positive n = 72Negative/unknownn = 43
MVI, n (%)28 (39)5 (15)NA4 (44)28 (39)9 (21)
AFP ≥ 400 (ng/mL), n (%)45 (62)10 (29)NA3 (33)45 (62)13 (30)
  • Abbreviations: AFP, α-fetoprotein; FISH, fluorescence in situ hybridization; HBV, hepatitis B virus; HCV, hepatitis C virus; MVI, macrovascular invasion; NA, not available; TACE, transarterial chemoembolization.