Table 3.
Baseline characteristics of the patients in the sharp and phase I/II trial
| Characteristics | SHARP trial | Phase I/II trial | P value |
|---|---|---|---|
| Age, years | 64.9 | 69.4 | 0.22 |
| Male no (%) | 260 (87 %) | 80 (78.4 %) | 0.244 |
| Underlying liver disease | 0.011 | ||
| Hepatitis B | 56 (19 %) | 39 (38.2 %) | |
| Hepatitis C | 87 (29) | 39 (38.2 %) | |
| Alcohol related | 79 (26 %) | 25 (24.5 %) | |
| Other | 28 (9 %) | 14 (13.7 %) | |
| Unkown | 49 (16 %) | 7 (6.9) | |
| ECOG performance status n (%) | 0.225 | ||
| 0 | 161 (54 %) | 85 (83.3) | |
| 1 | 114 (38 %) | ||
| 2 | 24 (8 %) | 11 (10.8 %) | |
| BCLC stage | 0.208 | ||
| B (intermediate) | 54 (18 %) | 35 (34.3 %) | |
| C (advanced) | 244 (82 %) | 67 (65.7 %) | |
| Child-Pugh class, no (%) | < 0.0001 | ||
| A | 284 (95 %) | 102 (100 %) | |
| B | 14 (5 %) | 0 % | |
| Biochemical analysis | 0.25 | ||
| Albumin (g/dl) | 3.9 | 4.0 | |
| Total bilirubin (mg/dl) | 0.7 | 1.3 | |
| Alpha-fetoprotein | 44.3 ng/ml | 163 nmol/L | |
| Previous therapy | 0.079 | ||
| Surgery | 57 (19 %) | 9 (8.8 %) | |
| TACE | 86 (29 %) | 22 (21.6 %) | |
| RFA | 17 (6 %) | 35 (34.3 %) | |
| PEI | 28 (9 %) | 16 (15.7 %) | |
| Extrahepatic spread (no,%) | 159 (53 %) | 12 (11.8 %) | < 0.0001 |
| Vascular invasion (no,%) | 108 (36 %) | 20 (49 %) | < 0.0001 |
Abbreviations: ECOG Eastern Cooperative Oncology Group, BCLC Barcelona Clinic Liver Cancer staging system, TACE transarterial chemoembolization, RFA radiofrequency ablation, PEI percutaneous ethanol injection