Child–Pugh B subgroup | Overall populationa | |||||
---|---|---|---|---|---|---|
Cabozantinib (N = 51) | Placebo (N = 22) | Total (N = 73) | Cabozantinib (N = 470) | Placebo (N = 237) | Total (N = 707) | |
Median age (range), years | 63.0 (22–82) | 64.5 (50–85) | 64.0 (22–85) | 64 (22–86) | 64 (24–86) | 64 (22–86) |
Male, n (%) | 45 (88) | 20 (91) | 65 (89) | 379 (81) | 202 (85) | 581 (82) |
Geographic region, n (%) | ||||||
Asia | 14 (27) | 3 (14) | 17 (23) | 116 (25) | 59 (25) | 175 (25) |
Europe | 21 (41) | 12 (55) | 33 (45) | 231 (49) | 108 (46) | 339 (48) |
Australian/New Zealand | 1 (2) | 1 (5) | 2 (3) | 15 (3) | 11 (5) | 26 (4) |
Canada/USA | 15 (29) | 6 (27) | 21 (29) | 108 (23) | 59 (25) | 167 (24) |
Race, n (%) | ||||||
Asian | 17 (33) | 5 (23) | 22 (30) | 159 (34) | 82 (35) | 241 (34) |
White | 30 (59) | 14 (64) | 44 (60) | 264 (56) | 130 (55) | 394 (56) |
Black | 0 | 2 (9) | 2 (3) | 8 (2) | 11 (5) | 19 (3) |
Other | 1 (2) | 1 (5) | 2 (3) | 8 (2) | 2 (1) | 10 (1) |
Not reported | 3 (6) | 0 | 3 (4) | 31 (7) | 12 (5) | 43 (6) |
ECOG status, n (%) | ||||||
0 | 27 (53) | 12 (55) | 39 (53) | 245 (52) | 131 (55) | 376 (53) |
1 | 24 (47) | 10 (45) | 34 (47) | 224 (48) | 106 (45) | 330 (47) |
2 | 0 | 0 | 0 | 1 (< 1) | 0 | 1 (< 1) |
Aetiology of disease, n (%) | ||||||
HBV | 18 (35) | 6 (27) | 24 (33) | 178 (38) | 89 (38) | 267 (38) |
HCV | 16 (31) | 4 (18) | 20 (27) | 113 (24) | 55 (23) | 168 (24) |
Alcohol use | 19 (37) | 4 (18) | 23 (32) | 112 (24) | 39 (16) | 151 (21) |
Nonalcoholic steatohepatitis | 3 (6) | 2 (9) | 5 (7) | 43 (9) | 23 (10) | 66 (9) |
AFP, n (%) | ||||||
< 400 ng/mL | 31 (61) | 16 (73) | 47 (64) | 278 (59) | 136 (57) | 414 (59) |
≥ 400 ng/mL | 20 (39) | 6 (27) | 26 (36) | 192 (41) | 101 (43) | 293 (41) |
Albumin, n (%) | ||||||
< 35 g/L | 27 (53) | 11 (50) | 38 (52) | 131 (28) | 60 (25) | 191 (27) |
≥ 35 g/L | 24 (47) | 11 (50) | 35 (48) | 339 (72) | 177 (75) | 516 (73) |
Bilirubin, n (%) | ||||||
< 22.23 µmol/L | 40 (78) | 20 (91) | 60 (82) | 421 (90) | 221 (93) | 642 (91) |
≥ 22.23– < 29.07 µmol/L | 6 (12) | 2 (9) | 8 (11) | 37 (8) | 13 (5) | 50 (7) |
≥ 29.07 µmol/L | 5 (10) | 0 | 5 (7) | 12 (3) | 3 (1) | 15 (2) |
Extrahepatic spread of disease and/or macrovascular invasion, n (%) | 47 (92) | 17 (77) | 64 (88) | 398 (85) | 200 (84) | 598 (85) |
Extrahepatic spread of disease | 42 (82) | 15 (68) | 57 (78) | 369 (79) | 182 (77) | 551 (78) |
Macrovascular invasion | 22 (43) | 7 (32) | 29 (40) | 129 (27) | 81 (34) | 210 (30) |
ALBI grade, n (%) | ||||||
1 | 5 (10) | 1 (5) | 6 (8) | 186 (40) | 102 (43) | 288 (41) |
2 | 45 (88) | 21 (95) | 66 (90) | 282 (60) | 133 (56) | 415 (59) |
3 | 1 (2) | 0 | 1 (1) | 2 (< 1) | 2 (1) | 4 (1) |
Child–Pugh score, n (%)b | ||||||
5 | 13 (25) | 7 (32) | 20 (27) | 264 (56) | 153 (65) | 417 (59) |
6 | 33 (65) | 14 (64) | 47 (64) | 183 (39) | 78 (33) | 261 (37) |
≥ 7 | 4 (8) | 1 (5) | 5 (7) | 17 (4) | 5 (2) | 22 (3) |
Missing | 1 (2) | 0 | 1 (1) | 6 (1) | 1 (< 1) | 7 (1) |
Sites of disease, n (%) | ||||||
Liver | 45 (88) | 21 (95) | 66 (90) | 395 (84) | 216 (91) | 611 (86) |
Bone | 9 (18) | 2 (9) | 11 (15) | 60 (13) | 34 (14) | 94 (13) |
Visceral (excluding liver) | 24 (47) | 9 (41) | 33 (45) | 215 (46) | 105 (44) | 320 (45) |
Lymph node | 19 (37) | 3 (14) | 22 (30) | 155 (33) | 71 (30) | 226 (32) |
Number of prior systemic anticancer regimens for advanced HCC, n (%) | ||||||
0 | 1 (2) | 0 | 1 (1) | 3 (1) | 0 | 3 (< 1) |
1 | 33 (65) | 13 (59) | 46 (63) | 335 (71) | 174 (73) | 509 (72) |
2 | 16 (31) | 9 (41) | 25 (34) | 130 (28) | 62 (26) | 192 (27) |
≥ 3 | 1 (2) | 0 | 1 (1) | 2 (< 1) | 1 (< 1) | 3 (< 1) |
TACE for HCC, N (%) | 26 (51) | 13 (59) | 39 (53) | 203 (43) | 111 (47) | 314 (44) |
Median total duration of prior sorafenib (range), months | 5.4 (1.1–40.0) | 7.1 (1.0–29.2) | 5.4 (1.0–40.0) | 5.3 (0.3–70.0) | 4.8 (0.2–76.8) | 5.2 (0.2–76.8) |
Median time from disease progression to randomisation (range), moc | 1.5 (0.2–100.8) | 1.9 (0.4–69.4) | 1.5 (0.2–100.8) | 1.6 (0–100.8) | 1.7 (0.2–69.4) | 1.6 (0–100.8) |