Table 3.
Summary of Outcomes of EP
| Measure | Level | Treatment Arm1 (N = 8) | Treatment Arm2 (N = 10) | All (N = 18) | p-value |
|---|---|---|---|---|---|
| Follow-up (months) | Mean (SD) | 9.7 (4.3) | 9.1 (2.9) | 9.3 (3.5) | 0.71 |
| Median (Min, Max) | 11.3 (4.2, 14.8) | 9.1 (5.0, 13.1) | 10.1 (4.2, 14.8) | ||
| Best response, n (%) | CR | 1 (13) | 2 (20) | 3 (17) | 1.00 |
| PR | 3 (38) | 3 (30) | 6 (33) | ||
| SD | 3 (38) | 3 (30) | 6 (33) | ||
| PD | 1 (13) | 2 (20) | 3 (17) | ||
| Duration of best response (months) | Number of patients | 4 | 5 | 9 | 0.56 |
| Mean (SD) | 6.3 (1.4) | 7.4 (2.1) | 6.9 (1.8) | 0.73 | |
| Median (Min, Max) | 6.9 (4.2, 7.4) | 6.8 (5.6,11.0) | 6.8 (4.2, 11.0) | ||
| Overall survival | Number of deaths | 1 | 1 | 2 | 0.81 |
| 1-year rate % (95% CI) | 88 (39, 98) | 88 (39, 98) | 87 (57, 97) | ||
| Progression-free survival | Number of events | 3 | 2 | 5 | 0.59 |
| 1-year rate % (95% CI) | 58 (18, 84) | 80 (41, 95) | 68 (37, 86) | ||
| Duration of clinical benefit (months) | Mean (SD) | 7.0 (3.1) | 6.0 (3.0) | 6.4 (3.0) | 0.59 |
| Median (Min, Max) | 7.0 (2.1, 10.7) | 6.5 (1.5, 11.0) | 6.8 (1.5, 11.0) |
Abbreviations: CI = confidence interval; CR = complete remission; EP = Evaluable Population; Max = Maximum; Min = Minimum; PD = progressive disease; PR = partial response; SD = standard deviation.