Table 5.
Summary of time-to-recurrence, disease-free survival probability, and overall survival results from the follow-up study n (%)
| Probability | 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 | |
| TTR probability1 | 45.9% | 29.8% | 61.5% | 48.1% |
| Difference | -16.1% | -13.4% | ||
| 95%CI | -33.6-1.5 | -31.5-4.7 | ||
| Rate of improvement2 | 35.1% | 21.8% | ||
| P value3 | 0.086 | 0.187 | ||
| DFS probability4 | 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 improvement | 26.4% | 28.1% | ||
| P value | 0.129 | 0.257 | ||
| OS probability | 90.9% | 88.6% | 81.0% | 82.8% |
| Difference | -2.3% | 1.7% | ||
| 95%CI | -13.4-8.8 | -12.4-15.9 | ||
| Rate of improvement | -2.5% | 2.2% | ||
| P value | 0.760 | 1.000 | ||
1,4Values from Figure 2 respectively;
2
Percent change in endpoint probability of treated group from untreated control;
3
Fisher’s exact test. Although not statistically significant, time-to-recurrence (TTR) and disease-free survival (DFS) probabilities and rates of improvements in the 160 mg/d group indicate substantial clinical advantages. Similarities in the two rates of DFS improvement indicate that the clinical benefits of 36 wk of treatment with 160 mg/d PI-88 persisted for up to 3 years. Despite the clinical survival benefits indicated by DFS, overall survival (OS) benefits were inconclusive.