Table 4.
Summary of progression-free survival (PFS).
| Cohort 1, 200 mg/week (n = 3) | Cohort 2, 400 mg/week (n = 7) | Total (N = 10) | |
|---|---|---|---|
| Median PFSa, months (95% CI) | 2.37 (2.33, 6.01) | NE (2.30, NE) | 5.01 (2.30, NE) |
| Events, n | 3 | 3 | 6 |
| Progression-free rates, % (95% CI) | |||
| 3 months | 33.3 (0.9, 77.4) | 71.4 (25.8, 92.0) | 60.0 (25.3, 82.7) |
| 6 months | 33.3 (0.9, 77.4) | 57.1 (17.2, 83.7) | 50.0 (18.4, 75.3) |
| 9 months | 0.0 | 57.1 (17.2, 83.7) | 40.0 (12.3, 67.0) |
| 12 months | 0.0 | 57.1 (17.2, 83.7) | 40.0 (12.3, 67.0) |
| PFS-6, % (95% CI)b | 33.3 [0.8, 90.6] | 57.1 [18.4, 90.1] | 50.0 [18.7, 81.3] |
| Disease progression within 6 months, n | 2 | 3 | 5 |
NE not evaluable (four patients in Cohort 2 had not experienced progression at the time of cut-off).
aKaplan–Meier methodology is used to estimate median time and its 95% confidence interval (CI).
bExact 95% CI is calculated according to Clopper–Pearson.