Table 1.
Baseline patient characteristics, n (%)
|
Variable
|
Category
|
No AEs or AEs grade < 2
|
AEs grade ≥ 2
|
OR
|
95%CI
|
P value
|
| n = 361 | 274 (76)1 | 87 (24) | ||||
| Age (Median) | 65 | 64 | 0.99 | (0.97, 1.01) | 0.450 | |
| Sex | Male | 222 (61) | 65 (18) | 1.00 | ||
| Female | 52 (14) | 22 (7) | 1.44 | (0.82, 2.56) | 0.206 | |
| AFP (Median) | 115 | 29 | 1.00 | (1, 1) | 0.850 | |
| Known cirrhosis | Yes | 201 (56) | 62 (17) | 0.90 | (0.53, 1.54) | 0.702 |
| No | 73 (20) | 25 (7) | 1.00 | |||
| Known PVT | Yes | 61 (17) | 18 (5) | 0.60 | (0.33, 1.1) | 0.100 |
| No | 124 (34) | 61 (17) | 1.00 | |||
| NLR | NLR ≤ 5 | 122 (34) | 62 (17) | 1.00 | ||
| NLR > 5 | 54 (15) | 16 (5) | 0.58 | (0.31, 1.1) | 0.096 | |
| Unknown | 98 (27) | 9 (2) | ||||
| PLR | PLR ≤ 300 | 145 (40) | 72 (20) | 1.00 | ||
| PLR > 300 | 31 (9) | 6 (2) | 0.39 | (0.16, 0.98) | 0.044 | |
| Unknown | 98 (27) | 9 (2) | ||||
| Child pugh class | A | 202 (56) | 74 (20) | 1.00 | ||
| B | 61 (17) | 13 (4) | 0.58 | (0.3, 1.12) | 0.105 | |
| C | 7 (2) | 0 (0) | 0.00 | (0, Inf) | 0.986 | |
| Unknown | 4 (1) | 0 (0) | ||||
| HCV | Yes | 112 (31) | 41 (11) | 1.29 | (0.79, 2.09) | 0.305 |
| No | 162 (45) | 46 (13) | 1.00 | |||
| HBV | Yes | 59 (16) | 18 (5) | 0.95 | (0.53, 1.72) | 0.867 |
| No | 215 (60) | 69 (19) | 1.00 | |||
| EtOH | Yes | 48 (13) | 17 (5) | 1.14 | (0.62, 2.11) | 0.669 |
| No | 226 (63) | 70 (19) | 1.00 | |||
| NASH | Yes | 37 (10) | 8 (2) | 0.65 | (0.29, 1.45) | 0.292 |
| No | 237 (66) | 79 (22) | 1.00 | |||
| BCLCs | A | 9 (2) | 1 (1) | 1.00 | ||
| B | 66 (18) | 25 (7) | 3.41 | (0.41, 28.31) | 0.256 | |
| C | 194 (53) | 61 (17) | 2.83 | (0.35, 22.79) | 0.328 | |
| D | 4 (1) | 0 (0) | 0.00 | (0, Inf) | 0.985 | |
| Unknown | 1 (1) | 0 (0) | ||||
| Extra Hepatic Disease | Yes | 100 (28) | 36 (10) | 0.73 | (0.43, 1.23) | 0.239 |
| No | 87 (24) | 43 (12) | 1.00 | |||
| Unknown | 87 (24) | 8 (2) | ||||
| ECOG | 0 | 168 (47) | 77 (21) | 1.00 | ||
| 1 | 18 (5) | 2 (1) | 0.24 | (0.05, 1.07) | 0.062 | |
| Unknown | 88 (24) | 8 (2) | ||||
| Steroid use | Yes | 57 (16) | 37 (10) | 2.74 | (1.61, 4.64) | 0.0002 |
| No | 190 (53) | 45 (12) | ||||
| Unknown | 27 (7) | 5 (2) | ||||
| Antibiotic use | Yes | 42 (12) | 14 (4) | 1.01 | (0.52, 1.98) | 0.95 |
| No | 205 (56) | 67 (19) | ||||
| Unknown | 27 (7) | 6 (2) | ||||
| Treatment | PD-1 | 244 (68) | 61 (17) | |||
| PD-1/CLTA-4 | 16 (4) | 12 (3) | 3.00 | (1.35, 6.67) | 0.007 | |
| PD-1/TKI | 12 (3) | 12 (3) | 4.00 | (1.71, 9.34) | 0.001 | |
| PD-1/other | 1 (0) | 1 (0) | 4.00 | (0.25, 64.86) | 0.329 | |
| CTLA-4 | 1 (0) | 1 (0) | 4.00 | (0.25, 64.86) | 0.32 |
1
Of 274 (76%) with no adverse events (AEs) or AEs grade < 2, 80 (22%) had grade 1 AEs and 194 (54%) had no AEs.
OR: Odds ratio; CI: Confidence Interval; AEs: Adverse events; AFP: Alpha-fetoprotein; ECOG: Eastern cooperative oncology group; BCLCs: Barcelona clinic liver cancers; NASH: Nonalcoholic steatohepatitis; HBV: Hepatitis B virus; HCV: Hepatitis C virus infection; PLR: Platelet-lymphocyte ratio; NLR: Neutrophil-lymphocyte ratio; PVT: Portal vein thrombosis; PD-1: Programmed cell death ligand 1; CLTA-4: Cytotoxic T-lymphocyte antigen-4; TKI: Tyrosine kinase inhibitor.