Table 1.
Patient demographics according to baseline ALBI grade.
| ALBI grade 1 | ALBI grade 2 | |||
|---|---|---|---|---|
| Characteristic | Pembrolizumab + BSC (n = 74) | Placebo + BSC (n = 42) | Pembrolizumab + BSC (n = 193) | Placebo + BSC (n = 86) |
| Age, median (range), years | 66.0 (21–82) | 64.5 (23–81) | 67.0 (18–91) | 65.5 (26–89) |
| Sex | ||||
| Male | 54 (73.0) | 34 (81.0) | 163 (84.5) | 72 (83.7) |
| Female | 20 (27.0) | 8 (19.0) | 30 (15.5) | 14 (16.3) |
| Region | ||||
| Asia (excluding Japan) | 24 (32.4) | 13 (31.0) | 43 (22.3) | 18 (20.9) |
| Europe | 27 (36.5) | 12 (28.6) | 65 (33.7) | 28 (32.6) |
| Japan | 5 (6.8) | 5 (11.9) | 34 (17.6) | 14 (16.3) |
| USA | 1 (1.4) | 2 (4.8) | 19 (9.8) | 12 (14.0) |
| Rest of worlda | 17 (23.0) | 10 (23.8) | 32 (16.6) | 14 (16.3) |
| ECOG PS | ||||
| 0 | 43 (58.1) | 29 (69.0) | 115 (59.6) | 37 (43.0) |
| 1 | 31 (41.9) | 13 (31.0) | 78 (40.4) | 49 (57.0) |
| Child–Pugh class | ||||
| A | 74 (100.0) | 42 (100.0) | 192 (99.5) | 85 (98.8) |
| A5 | 71 (95.9) | 42 (100.0) | 104 (53.9) | 43 (50.0) |
| A6 | 3 (4.1) | 0 | 88 (45.6) | 42 (48.8) |
| B | 0 | 0 | 1 (0.5) | 1 (1.2) |
| Overall BCLC stage | ||||
| B | 11 (14.9) | 5 (11.9) | 44 (22.8) | 23 (26.7) |
| C | 63 (85.1) | 37 (88.1) | 149 (77.2) | 63 (73.3) |
| HBV infectionb | 26 (35.1) | 11 (26.2) | 46 (23.8) | 18 (20.9) |
| HCV infectionc | 8 (10.8) | 1 (2.4) | 34 (17.6) | 20 (23.3) |
| Discontinuation of previous sorafenib | ||||
| Intolerance | 8 (10.8) | 5 (11.9) | 26 (13.5) | 11 (12.8) |
| PD | 66 (89.2) | 37 (88.1) | 167 (86.5) | 75 (87.2) |
| Extrahepatic disease | 59 (79.7) | 34 (81.0) | 127 (65.8) | 54 (62.8) |
| Macrovascular invasion | 4 (5.4) | 3 (7.1) | 28 (14.5) | 12 (14.0) |
| AFP ⩾200 ng/mL | 33 (44.6) | 17 (40.5) | 90 (46.6) | 37 (43.0) |
a
Includes Argentina, Australia, Canada, Chile, Colombia, Israel, Mexico, Norway, Russian Federation, and Turkey.
b
HBV infection defined as hepatitis B surface antigen positive and/or detectable HBV DNA.
c
HCV infection defined as anti-hepatitis C antibody positive and detectable HCV RNA.
AFP, alpha-fetoprotein; ALBI, albumin/bilirubin; BCLC, Barcelona Clinic Liver Cancer scale; BSC, best supportive care; ECOG PS, Eastern Cooperative Oncology Group performance status; HBV, hepatitis B virus; HCV, hepatitis C virus; PD, progressive disease.