Table 1.
Patient characteristics of responders and non-responders in the SILIUS trial
| Characteristics | All cohort |
Sorafenib alone group |
Sorafenib plus HAIC group |
|||
|---|---|---|---|---|---|---|
| responders (n = 55) | non-responders (n = 123) | responders (n = 18) | non-responders (n = 78) | responders (n = 37) | non-responders (n = 45) | |
| Age, n (%) | ||||||
| ≥65 years | 35 (64) | 82 (67) | 14 (78) | 54 (69) | 21 (57) | 28 (62) |
| <65 years | 20 (36) | 41 (33) | 4 (22) | 24 (31) | 16 (43) | 17 (38) |
| Sex, n (%) | ||||||
| Male | 47 (85) | 108 (88) | 15 (83) | 67 (86) | 32 (86) | 41 (91) |
| Female | 8 (15) | 15 (12) | 3 (17) | 11 (14) | 5 (14) | 4 (9) |
| Performance status, n (%) | ||||||
| 0 | 50 (91) | 107 (87) | 17 (94) | 69 (88) | 33 (89) | 38 (84) |
| 1 | 5 (9) | 16 (13) | 1 (6) | 9 (12) | 4 (11) | 7 (16) |
| Etiology HBV, n (%) | ||||||
| Yes | 14 (25) | 28 (23) | 4 (22) | 15 (19) | 10 (27) | 13 (29) |
| No | 40 (73) | 94 (76) | 13 (72) | 62 (79) | 27 (73) | 32 (71) |
| Indeterminate | 1 (2) | 1 (1) | 1 (6) | 1 (1) | 0 (0) | 0 (0) |
| Etiology HCV, n (%) | ||||||
| Yes | 26 (47) | 54 (44) | 9 (50) | 34 (44) | 17 (46) | 20 (44) |
| No | 28 (51) | 67 (54) | 8 (44) | 43 (55) | 20 (54) | 24 (53) |
| Indeterminate | 1 (2) | 2 (2) | 1 (6) | 1 (1) | 0 (0) | 1 (2) |
| ALBI grade, n (%) | ||||||
| 1 | 24 (44) | 40 (33) | 9 (50) | 28 (36) | 15 (41) | 12 (27) |
| 2 | 31 (56) | 82 (67) | 9 (50) | 50 (64) | 22 (59) | 32 (71) |
| 3 | 0 (0) | 1 (1) | 0 (0) | 0 (0) | 0 (0) | 1 (2) |
| Albumin, n (%) | ||||||
| ≥3.7 g/dL | 34 (62) | 62 (50) | 10 (56) | 43 (55) | 24 (65) | 19 (42) |
| <3.7 g/dL | 21 (38) | 61 (50) | 8 (44) | 35 (45) | 13 (35) | 26 (58) |
| Bilirubin, n (%) | ||||||
| <0.8 mg/dL | 33 (60) | 53 (43) | 15 (83) | 30 (38) | 18 (49) | 23 (51) |
| ≥0.8 mg/dL | 22 (40) | 70 (57) | 3 (17) | 48 (62) | 19 (51) | 22 (49) |
| Macroscopic portal vein invasion, n (%) | ||||||
| Vp0 | 23 (42) | 49 (40) | 7 (39) | 30 (38) | 16 (43) | 19 (42) |
| Vp1-4 | 32 (58) | 74 (60) | 11 (61) | 48 (62) | 21 (57) | 26 (58) |
| Extrahepatic spread, n (%) | ||||||
| Yes | 15 (27) | 31 (25) | 5 (28) | 19 (24) | 10 (27) | 12 (27) |
| No | 40 (73) | 92 (75) | 13 (72) | 59 (76) | 27 (73) | 33 (73) |
| Baseline serum AFP, n (%) | ||||||
| <400 ng/mL | 30 (55) | 63 (51) | 11 (61) | 41 (53) | 19 (51) | 22(49) |
| ≥400 ng/mL | 23 (42) | 60 (49) | 7 (39) | 37 (47) | 16 (43) | 23 (51) |
| Missing | 2 (4) | 0 (0) | 0 (0) | 0 (0) | 2 (5) | 0 (0) |
| Baseline serum DCP, n (%) | ||||||
| <2,050 mAU/mL | 27 (49) | 61 (50) | 9 (50) | 42 (54) | 18 (49) | 19 (42) |
| >2,050 mAU/mL | 25 (45) | 62 (50) | 8 (44) | 36 (46) | 17 (46) | 26 (58) |
| Missing | 3 (5) | 0(0) | 1 (6) | 0 (0) | 2 (5) | 0 (0) |
| mRECIST BOR, n (%) | ||||||
| Complete response | 10 (18) | 0 (0) | 2 (11) | 0 (0) | 8 (22) | 0 (0) |
| Partial response | 45 (82) | 0 (0) | 16 (89) | 0 (0) | 29 (78) | 0 (0) |
| Stable disease | 0 (0) | 86 (70) | 0 (0) | 57 (73) | 0 (0) | 29 (64) |
| Progressive disease | 0 (0) | 37 (30) | 0 (0) | 21 (27) | 0 (0) | 16 (36) |
| Treatment, n (%) | ||||||
| Sorafenib + HAIC | 37 (67) | 45 (37) | ||||
| Sorafenib | 18 (33) | 78 (63) | ||||
ALBI grade, albumin-bilirubin grade; AFP, alfa-fetoprotein; DCP, des-γ-carboxy prothrombin; BOR, best objective response; HAIC, hepatic arterial infusion chemotherapy.