Background
Methods
Patients
Statistical methods
Results
Patient characteristics
Characteristic | |
---|---|
Age, years | |
Mean ± SD | 55.43 ± 10.69 |
Range | 11–84 |
Sex, % | |
Male | 252 (82.1) |
Female | 55 (17.9) |
ECOG PS, % | |
0 | 100 (32.6) |
1 | 146 (47.6) |
2 | 44 (14.3) |
3 | 16 (5.2) |
4 | 1 (0.3) |
Etiology, % | |
HBV | 239 (77.8) |
HCV | 7 (2.3) |
HBV + HCV | 2 (0.7) |
Alcoholism | 5 (1.6) |
Other | 54 (17.6) |
Child-Pugh Grade, % | |
A | 239 (77.9) |
B | 56 (18.2) |
C | 12 (3.9) |
Child-Pugh Score, % | |
5 | 176 (57.4) |
6 | 63 (20.5) |
7 | 36 (11.7) |
8 | 9 (2.9) |
9 | 11 (3.6) |
10 | 9 (2.9) |
11 | 3 (1.0) |
Hepatic encephalopathy, % | |
No | 307 (100.0) |
Yes | 0 (0) |
Ascites, % | |
No | 219 (71.4) |
Little | 56 (18.2) |
Middle | 24 (7.8) |
Large | 8 (2.6) |
Portal hypertension, % | |
No | 245 (79.8) |
Yes | 62 (20.2) |
Cirrhosis, % | |
No | 97 (31.6) |
Yes | 210 (68.4) |
Laboratory values, mean ± SD | |
Total bilirubin (μmol/l) | 24.55 ± 50.93 |
Albumin (g/l) | 38.53 ± 5.78 |
Prothrombin time (sec) | 0.19 ± 0.80 |
AFP (ng/ml), % | |
< 400 | 211 (68.7) |
≥ 400 | 96 (31.3) |
Tumor characteristics | |
Tumor size (mean ± SD, cm) | 6.18 ± 4.04 |
Number of lesions, % | |
1 | 200 (65.2) |
2–3 | 29 (9.4) |
≥ 4 | 78 (25.4) |
Lobar involvement, % | |
Unilobar | 164 (53.4) |
≥ bilobar | 143 (46.6) |
Tumor morphology, % | |
Uninodular | 147 (47.9) |
Multinodular | 77 (25.1) |
Massive, diffuse | 83 (27.0) |
Vascular and/or organ invasion, % | |
No | 235 (76.6) |
Portal/hepatic vein | 52 (16.9) |
Other vascular | 9 (2.9) |
Organ invasion | 11 (3.6) |
N, % | |
No | 252 (82.1) |
Yes | 55 (17.9) |
M, % | |
No | 278 (90.6) |
Yes | 29 (9.4) |
Tumor thrombosis, % | |
None | 247 (80.4) |
Portal stem vein | 26 (8.5) |
Inferior vena cava | 6 (1.9) |
Hepatic vein branches | 2 (0.7) |
Portal vein branches | 16 (5.2) |
Vessel | 3 (1.0) |
Hepatic duct | 2 (0.7) |
Inferior vena cava branches and Portal vein branches and/or Hepatic vein branches | 5 (1.6) |
Current outcomes, % | |
Dead | 120 (39.1) |
Alive | 187 (60.9) |
OS, mean ± SD, months | 12.08 ± 11.87 |
Staging system | Patients (%) |
---|---|
CLIP | |
0 | 95 (30.9) |
1 | 86 (28.0) |
2 | 42 (13.7) |
3 | 53 (17.3) |
4 | 21 (6.8) |
5 | 8 (2.6) |
6 | 2 (0.7) |
BCLC | |
0 | 10 (3.3) |
A | 45 (14.7) |
B | 32 (10.4) |
C | 196 (63.8) |
D | 24 (7.8) |
TNMa
| |
I | 133 (43.3) |
II | 41 (13.4) |
IIIA | 15 (4.9) |
IIIB | 37 (12.0) |
IIIC | 11 (3.6) |
IVA | 41 (13.4) |
IVB | 29 (9.4) |
CS | |
Ia | 49 (16.0) |
Ib | 42 (13.7) |
IIa | 51 (16.6) |
IIb | 63 (20.5) |
IIIa | 90 (29.3) |
IIIb | 12 (3.9) |
Baseline predictors of survival
Variable | Coefficient | SE | P | HR | 95 % CI |
---|---|---|---|---|---|
Sex | 0.39 | 0.28 | 0.156 | 1.48 | 0.86–2.54 |
Age | −0.09 | 0.08 | 0.293 | 0.92 | 0.78–1.08 |
ECOG PS | 0.74 | 0.10 | 0.000 | 2.10 | 1.74–2.54 |
Tumor size | 0.15 | 0.02 | 0.000 | 1.16 | 1.12–1.21 |
Number of lesions | 0.58 | 0.10 | 0.000 | 1.78 | 1.47–2.17 |
Lobar involvement | 1.16 | 0.20 | 0.000 | 3.20 | 2.18–4.70 |
Tumor formation | 0.70 | 0.11 | 0.000 | 2.01 | 1.63–2.49 |
Ascites | 0.44 | 0.10 | 0.000 | 1.55 | 1.27–1.89 |
Total bilirubin | 0.68 | 0.14 | 0.000 | 1.98 | 1.51–2.60 |
Albumin | −0.10 | 0.02 | 0.000 | 0.91 | 0.88–0.94 |
Child-Pugh Grade | 0.86 | 0.16 | 0.000 | 2.37 | 1.72–3.25 |
alpha-fetoprotein | 0.72 | 0.18 | 0.000 | 2.05 | 1.43–2.94 |
hepatitis B virus | −0.37 | 0.21 | 0.081 | 0.69 | 0.46–1.05 |
hepatitis C virus | −0.55 | 0.59 | 0.347 | 0.58 | 0.18–1.82 |
Alcoholism | 0.53 | 0.59 | 0.366 | 1.70 | 0.54–5.36 |
Other | 0.42 | 0.23 | 0.066 | 1.53 | 0.97–2.39 |
Lymph node metastasis | 0.81 | 0.21 | 0.000 | 2.26 | 1.48–3.43 |
Distant metastasis | 1.37 | 0.22 | 0.000 | 3.93 | 2.56–6.05 |
Tumor thromboses | 1.31 | 0.20 | 0.000 | 3.71 | 2.50–5.50 |
Portal hypertension | 0.30 | 0.22 | 0.173 | 1.35 | 0.88–2.09 |
Cirrhosis | −0.80 | 0.18 | 0.000 | 0.45 | 0.31–0.64 |
Vascular/organ invasion | |||||
Portal/hepatic vein | 1.31 | 0.21 | 0.000 | 3.72 | 2.47–5.60 |
Others | 0.79 | 0.33 | 0.015 | 2.21 | 1.17–4.18 |
Variables | Coefficient | SE | P | HR | 95 % CI |
---|---|---|---|---|---|
Cirrhosis | −0.56 | 0.21 | 0.008 | 0.57 | 0.38–0.87 |
Tumor size | 0.11 | 0.02 | 0.000 | 1.12 | 1.07–1.17 |
Number of lesions | 0.36 | 0.11 | 0.001 | 1.44 | 1.16–1.79 |
Total bilirubin | 0.56 | 0.16 | 0.000 | 1.74 | 1.28–2.37 |
Albumin | −0.04 | 0.02 | 0.019 | 0.96 | 0.93–0.99 |
Tumor thromboses | 0.70 | 0.22 | 0.001 | 2.01 | 1.31–3.09 |
Survival comparisons among staging groups
Ranking of discriminatory ability of staging system
Rank | System | C-index | 95 % CI |
---|---|---|---|
1 | CS | 0.75 | 0.71–0.80 |
2 | CLIP | 0.74 | 0.69–0.79 |
3 | TNMa
| 0.70 | 0.65–0.75 |
4 | BCLC | 0.69 | 0.65–0.73 |
Discussion
Stage | Tumor size (cm) and location | Thrombosis | N | M | Child-Pugh score |
---|---|---|---|---|---|
Ia | single, ≤ 3 | absent | absent | absent | A |
Ib | unilobar, ≤ 5 | absent | absent | absent | A |
IIa | unilobar, ≤ 10; or bilobar, ≤ 5 | absent | absent | absent | A |
IIb | unilobar, >10; or bilobar, > 5; any | absent; portal vein, or inferior vena cava, or biliary duct branches | absent | absent | |
absent | absent | A or B | |||
IIIa | any; | portal vein, or inferior vena cava, or biliary duct stem; | any | any | A or B |
any; | any; | present | any | ||
any | any | any | present | ||
IIIb | any | any | any | any | C |