Table 1.
Baseline and disease characteristics.
| Category | Lenvatinib |
Sorafenib |
||
|---|---|---|---|---|
| CP-B subgroup a , n = 60 | CP-A subgroup b , n = 413 | CP-B subgroup a , n = 47 | CP-A subgroup b , n = 427 | |
| Median age, years (range) | 64.0 (34–86) | 63.0 (20–88) | 64.0 (26–79) | 62.0 (22–88) |
| Sex, n (%) | ||||
| Male | 45 (75.0) | 355 (86.0) | 38 (80.9) | 362 (84.8) |
| Female | 15 (25.0) | 58 (14.0) | 9 (19.1) | 65 (15.2) |
| Body weight, n (%) | ||||
| <60 kg | 21 (35.0) | 132 (32.0) | 16 (34.0) | 128 (30.0) |
| ⩾60 kg | 39 (65.0) | 281 (68.0) | 31 (66.0) | 299 (70.0) |
| ECOG performance status, n (%) | ||||
| 0 | 40 (66.7) | 264 (63.9) | 18 (38.3) | 283 (66.3) |
| 1 | 20 (33.3) | 149 (36.1) | 29 (61.7) | 144 (33.7) |
| Factor of carcinogenesis, n (%) | ||||
| Hepatitis B | 29 (48.3) | 219 (53.0) | 20 (42.6) | 206 (48.2) |
| Hepatitis C | 15 (25.0) | 75 (18.2) | 12 (25.5) | 114 (26.7) |
| Alcohol | 7 (11.7) | 28 (6.8) | 3 (6.4) | 18 (4.2) |
| Other | 6 (10.0) | 32 (7.7) | 3 (6.4) | 29 (6.8) |
| Unknown | 3 (5.0) | 59 (14.3) | 9 (19.1) | 60 (14.1) |
| Median sum of tumor diameters, mm (range) | 69.5 (11–225) | 59.6 (10–284) | 77.2 (13–273) | 60.5 (10–283) |
| ALBI score, n (%) | ||||
| 1 | 16 (26.7) | 302 (73.1) | 18 (38.3) | 322 (75.4) |
| 2 | 44 (73.3) | 111 (26.9) | 29 (61.7) | 104 (24.4) |
| 3 | 0 | 0 | 0 | 1 (0.2) |
| BCLC stage, n (%) | ||||
| B | 14 (23.3) | 89 (21.5) | 2 (4.3) | 90 (21.1) |
| C | 46 (76.7) | 324 (78.5) | 45 (95.7) | 337 (78.9) |
| CP score, n (%) | ||||
| 5 | 21 (35.0) | 345 (83.5) | 21 (44.7) | 335 (78.5) |
| 6 | 36 (60.0) | 68 (16.5) | 21 (44.7) | 92 (21.5) |
| 7 | 3 (5.0) | 0 | 4 (8.5) | 0 |
| 8 | 0 | 0 | 1 (2.1) | 0 |
| AFP level ⩾200 ng/mL, n (%) | 33 (55.0) | 186 (45.0) | 25 (53.2) | 161 (37.7) |
| Macroscopic portal vein invasion, extrahepatic spread, or both, n (%) | ||||
| Yes | 45 (75.0) | 280 (67.8) | 38 (80.9) | 297 (69.6) |
| No | 15 (25.0) | 133 (32.2) | 9 (19.1) | 130 (30.4) |
| Underlying cirrhosis c , n (%) | ||||
| Yes | 54 (90.0) | 298 (72.2) | 39 (83.0) | 324 (75.9) |
| No | 6 (10.0) | 115 (27.8) | 8 (17.0) | 103 (24.1) |
a
Includes patients who deteriorated to CP-B liver function within 8 weeks post-randomization.
b
Includes patients with CP-A liver function within 8 weeks post-randomization.
c
By IIR.
AFP, alpha-fetoprotein; ALBI, albumin–bilirubin; BCLC, Barcelona Clinic Liver Cancer; CP, Child-Pugh; ECOG, Eastern Cooperative Oncology Group; IIR, independent imaging review.