Table 1.
Patients’ baseline characteristics in the training and validation groups.
| Training Group (n = 215) |
Validation Group (n = 113) |
p-Value | |
|---|---|---|---|
| Age (years) | 69 (IQR 14) | 68 (IQR 13,5) | 0.912 |
| Gender (M/F) | 183/32 (85.1%/14.9%) | 89/24 (78.8%/21.2%) | 0.165 |
| Sarcopenia (yes/no) | 103/112 (47.9%/52.1%) | 56/57 (49.6%/50.4%) | 0.817 |
Etiology of cirrhosis
|
0.077 | ||
| 85 (39.5%) | 54 (47.8%) | ||
| 34 (15.8%) | 17 (15.0%) | ||
| 27 (12.6%) | 20 (17.7%) | ||
| 69 (32.1%) | 22 (19.5%) | ||
| BMI | 25.62 (IQR 5.7) | 24.60 (IQR 4.6) | 0.001 |
| Bilirubin (mg/dL) | 1.02 (IQR 0.8) | 0.97 (IQR 0.83) | 0.695 |
| INR | 1.16 (IQR 0.18) | 1.00 (IQR 0.16) | <0.001 |
| Albumin (g/dL) | 3.5 (IQR 0.61) | 3.8 (IQR 0.6) | 0.036 |
| Creatinine (mg/dL) | 0.85 (IQR 0.32) | 0.80 (IQR 0.30) | 0.557 |
| Esophageal varices | 107 (49.8%) | 65 (57.5%) | 0.201 |
| Platelets (×109/mmc) | 129 (IQR 107) | 123 (IQR 122) | 0.406 |
| Ascites | 63 (29.3%) | 23 (20.4%) | 0.087 |
| ALBI score | −2.19 (IQR 0.69) | −2.4 (IQR 0.60) | 0.051 |
| MELD score | 9 (IQR 3) | 8 (IQR 4) | 0.002 |
CTP class
|
0.214 | ||
| 161 (74.9%) | 92 (81.4%) | ||
| 54 (25.1%) | 21 (18.6%) | ||
| AFP baseline | 36 (IQR 538.2) | 45 (IQR 487.0) | 0.045 |
| Macrovascular invasion | 72 (33.5%) | 21 (18.6%) | 0.005 |
| Metastasis | 58 (27%) | 26 (23%) | 0.506 |
ECOG PS
|
0.013 | ||
| 108 (50.2%) | 40 (35.4%) | ||
| 78 (36.3%) | 46 (40.7%) | ||
| 29 (13.5%) | 27 (23.9%) | ||
BCLC stage
|
0.340 | ||
| 3 (1.4%) | 0 | ||
| 36 (16.7%) | 23 (20.4%) | ||
| 176 (81.9%) | 90 (79.6%) | ||
CLIP score
|
0.706 | ||
| 22 (10.2%) | 11 (9.7%) | ||
| 60 (27.9%) | 25 (22.1%) | ||
| 74 (34.4%) | 41 (36.3%) | ||
| 44 (20.5%) | 30 (26.5%) | ||
| 14 (6.5%) | 6 (5.3%) | ||
| 1 (0.5%) | 0 | ||
| PROSASH-II model | 0.325 ± 0.459 | 0.257 ± 0.4 | 0.211 |
PROSASH-II risk groups
|
0.443 | ||
| 39 (18.1%) | 22 (19.5%) | ||
| 79 (36.7%) | 49 (43.4%) | ||
| 67 (31.2%) | 32 (28.3%) | ||
| 30 (14%) | 10 (8.8%) | ||
| Treatment duration (days) | 135.0 (IQR 204.0) | 159 (IQR 199.0) | 0.972 |
Presence of adverse effects during Sorafenib
|
184 (85.6%) | 96 (85.0%) | 0.871 |
| 59 (27.4%) | 36 (31.9%) | 0.443 | |
Cause of Sorafenib discontinuation
|
0.044 | ||
| 5 (2.3%) | 0 | ||
| 112 (52.1%) | 45 (39.8%) | ||
| 58 (27.0%) | 46 (40.7%) | ||
| 15 (7.0%) | 10 (8.8%) | ||
| 25 (11.6%) | 12 (10.6%) |
Data are expressed as medians and interquartile ranges (IQRs) (in parenthesis) or percentages. Comparisons between groups were made by χ2 test or Fisher’s exact test (2-tailed) for qualitative variables, and the Mann–Whitney test or Kruskal–Wallis test for quantitative variables. Significant p-values are highlighted in bold. Abbreviations: AFP, Alpha-fetoprotein; ALBI, Albumin-Bilirubin; BCLC, Barcelona Clinic Liver Cancer; BMI, Body Mass Index; CLIP, Cancer Liver Italian Program; PROSASH-II, Prediction of Survival in Advanced Sorafenib-treated HCC-II; CTP, Child-Turcotte-Pugh; ECOG-PS, Eastern Cooperative Oncology Group Performance Status; INR, International Normalized Ratio; MELD, Model for End-stage Liver Disease.