Table 1.
Baseline demographics and disease characteristics
| Variables | Immunotherapy (n = 114) | Control (n = 112) | P value |
|---|---|---|---|
| Male sex, N (%) | 95 (83.3%) | 91 (81.3%) | 0.68e |
| Age, years | 55.4 ± 8.2 | 56.4 ± 10.6 | 0.41f |
| Treatment modality, N (%) | 0.06g | ||
| PEI | 13 (11.4%) | 4 (3.6%) | |
| RFA | 69 (60.5%) | 70 (62.5%) | |
| Surgical resection | 32 (28.1%) | 38d (33.9%) | |
| HCC stage, N (%)a | 0.67e | ||
| Stage I | 98 (86.0%) | 94 (83.9%) | |
| Stage II | 16 (14.0%) | 18 (16.1%) | |
| Number of HCC, N (%) | 0.98e | ||
| < 3 | 112 (98.2%) | 110 (98.2%) | |
| ≥ 3 | 2 (1.8%) | 2 (1.8%) | |
| Size of HCC, cm | 1.8 (1.4–2.3) | 2.3 (1.5–3.1) | 0.03h |
| ECOG status, N (%)b | 0.83e | ||
| 0 | 81 (71.1%) | 81 (72.3%) | |
| 1 | 33 (28.9%) | 31 (27.7%) | |
| Underlying liver disease, N (%) | 0.87g | ||
| HBV infection only | 96 (84.2%) | 90 (80.4%) | |
| HCV infection only | 9 (7.9%) | 10 (8.9%) | |
| HBV + HCV co-infection | 2 (1.8%) | 2 (1.8%) | |
| Others | 7 (6.1%) | 10 (8.9%) | |
| Cirrhosis, N (%)c | 76 (66.7%) | 70 (62.5%) | 0.51e |
| Alpha-fetoprotein, ng/mL | 5.2 (3.1–9.9) | 5.4 (3.0–13.0) | 0.56h |
| PIVKA-II, mAU/mL | 19.0 (14.0–24.8) | 18.0 (14.0–24.0) | 0.96h |
| AST, IU/L | 33.0 (27.0–43.5) | 34.0 (26.8–44.0) | 0.87h |
| ALT, IU/L | 33.0 (25.0–45.8) | 33.0 (23.0–47.5) | 0.55h |
| ALP, IU/L | 82.5 (70.0–101.5) | 82.0 (65.0–100.0) | 0.45h |
| Albumin, g/dL | 4.1 (3.9–4.3) | 4.1 (3.9–4.3) | 0.99h |
| Total bilirubin, mg/dL | 0.8 (0.6–1.0) | 0.8 (0.6–1.0) | 0.71h |
| Prothrombin time, s | 13.7 (13.1–14.7) | 13.9 (13.2–14.4) | 0.74h |
| Creatinine, mg/dL | 0.9 (0.8–1.0) | 0.9 (0.7–1.0) | 0.86h |
| Platelet, ×103/mm3 | 116.5 (92.3–158.0) | 141.0 (117.5–166.3) | 0.01h |
Data are expressed as N (%), mean ± SE, or median (interquartile range [Q1–Q3])
NS not significant, RFA radiofrequency ablation, PEI percutaneous ethanol injection, HCC hepatocellular carcinoma, IQR interquartile range, ECOG Eastern Cooperative Oncology Group, HBV hepatitis B virus, HCV hepatitis C virus, PIVKA-II protein induced by vitamin K absence-II, AST aspartate aminotransferase, ALT alanine aminotransferase, ALP alkaline phosphatase
aThe HCC staging was done according to AJCC staging system (6th edition) [18]
bThe ECOG performance status assesses the daily living abilities of the patient, on a scale ranging from 0 (fully active) to 5 (dead)
cLiver cirrhosis was diagnosed by the presence of histological and/or radiological evidence
dTwo of them underwent intrahepatic RFA in addition to surgical resection
eBy Chi-square test
fBy two sample t test
gBy Fisher’s exact test
hBy Wilcoxon rank sum test