Table 3.
Cox multivariate analysis for prognostic factors for survival 18 months after Sorafenib initiation. (A) training group. (B) validation group.
| (A) Training Group n = 215 | ||||
| Univariate Analysis | Multivariate Analysis | |||
| Variable | HR (95% CI) | p-Value | HR (95% CI) | p-Value |
| Gender (Male) | 1.05 (0.68–1.60) | 0.838 | ||
| Age (yr) | 0.99 (0.97–1.01) | 0.456 | ||
| BMI | 0.99 (0.96–1.03) | 0.785 | ||
| INR | 1.03 (0.35–3.00) | 0.963 | ||
| Bilirubin (mg/dL) | 1.35 (1.14–1.59) | <0.001 | ||
| Albumin (g/dL) | 0.80 (0.54–1.17) | 0.242 | ||
| Creatinine (mg/dL) | 1.02 (0.75–1.39) | 0.890 | ||
| Platelets (×109) | 1.00 (0.99–1.00) | 0.965 | ||
| Ascites | 1.63 (1.15–2.33) | 0.006 | 1.35 (0.93–1.97) | 0.119 |
| Oesophageal varices | 1.08 (0.79–1.49) | 0.625 | ||
| CTP class | 1.39 (1.14–1.68) | 0.001 | ||
| MELD | 1.08 (1.02–1.16) | 0.011 | ||
| MELD > 9 | 1.50 (1.04–2.17) | 0.030 | 1.37 (1.02–1.83) | 0.037 |
| ALBI score | 1.12 (0.70–1.79) | 0.633 | ||
| Sarcopenia | 1.45 (1.10–1.93) | 0.008 | 1.47 (1.05–2.07) | 0.026 |
| ECOG–PS | 1.32 (1.05–1.65) | 0.017 | 1.18 (0.93–1.51) | 0.178 |
| AFP | 1.000019 (1.000014–1.000024) | <0.001 | ||
| AFP (>25 ng/mL) | 1.72 (1.25–2.38) | 0.001 | 1.42 (0.97–2.07) | 0.07 |
| Macrovascular invasion | 1.70 (1.26–2.30) | 0.001 | 1.29 (0.85–1.95) | 0.228 |
| Metastasis | 1.07 (0.71–1.60) | 0.762 | ||
| BCLC | 1.35 (0.90–2.04) | 0.150 | ||
| PROSASH-II | 2.52 (1.62–3.93) | <0.001 | ||
| PROSASH-II risk groups | 1.47 (1.2–1.8) | <0.001 | 1.2 (0.95–1.52) | 0.134 |
| CLIP | 1.58 (1.18–2.13) | 0.002 | 1.07 (0.87–1.3) | 0.521 |
| (B) Validation Group n = 113 | ||||
| Univariate Analysis | Multivariate Analysis | |||
| Variable | HR (95% CI) | p -Value | HR (95% CI) | p -Value |
| Gender (Male) | 1.09 (0.66–1.79) | 0.744 | ||
| Age (yr) | 0.97 (0.95–1) | 0.041 | ||
| Age > 75 yr | 0.58 (0.33–1.01) | 0.055 | 0.57 (0.29–1.15) | 0.115 |
| BMI | 1.00 (0.95–1.06) | 0.888 | ||
| INR | 4.26 (0.71–25.59) | 0.113 | ||
| Bilirubin (mg/dL) | 1.30 (0.91–1.87) | 0.155 | ||
| Albumin (g/dL) | 0.58 (0.36–0.94) | 0.028 | ||
| Albumin < 3.8 g/dL | 1.80 (1.25–2.58) | 0.002 | 1.58 (0.79–3.18) | 0.2 |
| Creatinine (mg/dL) | 2.07 (0.65–6.59) | 0.217 | ||
| Platelets (×109) | 1.00 (0.99–1.01) | 0.190 | ||
| Ascites | 1.01 (0.60–1.71) | 0.965 | ||
| Oesophageal varices | 0.85 (0.59–1.23) | 0.380 | ||
| CTP class | 1.37 (0.98–1.90) | 0.064 | ||
| MELD > 9 | 1.96 (1.14–3.38) | 0.015 | 1.78 (1.04–3.03) | 0.035 |
| ALBI score | 1.38 (0.86–2.22) | 0.182 | ||
| Sarcopenia | 1.75 (1.17–2.63) | 0.007 | 1.99 (1.06–3.7) | 0.033 |
| ECOG–PS | 1.50 (1.17–1.93) | 0.001 | 1.51 (1.05–2.18) | 0.028 |
| AFP > 25 ng/ml | 1.75 (1.04–2.87) | 0.035 | 1.1 (0.6–2) | 0.765 |
| Macrovascular invasion | 1.07 (0.59–1.94) | 0.819 | ||
| Metastasis | 0.59 (0.28–1.26) | 0.174 | ||
| BCLC | 1.37 (0.67–2.82) | 0.393 | ||
| PROSASH-II risk groups | 1.27 (0.99–1.62) | 0.063 | 1.04 (0.68–1.59) | 0.852 |
| CLIP | 1.30 (0.78–2.17) | 0.312 | ||
Data are expressed as Hazard Ratio and 95% Confidence Interval. Univariate and multivariate analyses for OS were made using the Cox proportional hazards model. Significant p-values are highlighted in bold. AFP, Alpha-fetoprotein; ALBI, Albumin-Bilirubin; BCLC, Barcelona Clinic Liver Cancer; BMI, Body Mass Index; CLIP, Cancer Liver Italian Program; CTP, Child-Turcotte-Pugh; ECOG-PS, Eastern Cooperative Oncology Group Performance Status; INR, International Normalized Ratio; MELD, Model for End-stage Liver Disease; PROSASH-II, Prediction of Survival in Advanced Sorafenib-treated HCC-II.