Table 6.
Subgroup analyses comparing disease-free survival probabilities of the 160 mg/d group to their respective controls in the phase II and follow-up studies
| Subgroup analyses | Phase II study | 3-yr study | ||
|
Week 48 |
Week 156 |
|||
| Group A untreated | Group B 160 mg/d | Group A untreated | Group B 160 mg/d | |
| Study cohort | ||||
| DFS probability | 54.1% | 68.4% | 38.5% | 49.4% |
| Difference | 14.3% | 10.8% | ||
| 95%CI | -3.4-32.0 | -7.3-29.0 | ||
| Rate of improvement1 | 26.4% | 28.1% | ||
| P value2 | 0.129 | 0.257 | ||
| Intermediate-risk group (multiple or single tumor ≥ 2 cm) | ||||
| DFS probability | 45.1% | 63.8% | 33.0% | 48.4% |
| Difference | 18.7% | 15.4% | ||
| 95%CI | -0.8-38.2 | -3.9-34.7 | ||
| Rate of improvement | 41.5% | 46.6% | ||
| P value | 0.104 | 0.150 | ||
| High-risk group (multiple or single tumor ≥ 2 cm and positive HBV/HCV infection)3 | ||||
| DFS probability | 41.4% | 64.9% | 29.6% | 46.4% |
| Difference | 23.5% | 16.8% | ||
| 95%CI | 2.0-45.0 | -4.4-38.1 | ||
| Rate of improvement | 56.8% | 56.8% | ||
| P value | 0.045 | 0.163 | ||
1,2 Table 3 footnote 2 and 3;
3
Values from Figure 3. The clinical benefits of 160 mg/d PI-88 were more pronounced in intermediate and high-risk groups. Statistically significant survival benefits were observed in the high-risk group at the end of the phase II study. TTR: Time-to-recurrence; DFS: Disease-free survival; OS: Overall survival; HBV: Hepatitis B virus; HCV: Hepatitis C virus.