Patient outcomes
| . | 2 mg (n = 35) . | 4 mg (n = 35) . |
|---|---|---|
| Confirmed response rate | 26% (95% CI: 12-43) | 28% (95% CI: 14-46) |
| No. of responders | 9 | 10 |
| CR | 0 | 1 |
| VGPR | 5 | 3 |
| PR | 4 | 6 |
| MR | 8 | 5 |
| SD | 12 | 11 |
| PD | 3 | 8 |
| NE | 3 | 1 |
| Median time to response | 1 mo (range: 0.8-3.9) | 1.7 mo (range: 0.9-7.2) |
| Overall survival* | NA | NA |
| Event free at 6 mo, % | 78% (95% CI: 65-94) | 67% (95% CI: 52-86) |
| Progression-free survival* | 6.5 mo (95% CI: 3.9-8.9) | 3.2 mo (95% CI: 1.9-8.6) |
| Event free at 6 mo, % | 56% (95% CI: 41-75) | 34% (95% CI: 21-55) |
| . | 2 mg (n = 35) . | 4 mg (n = 35) . |
|---|---|---|
| Confirmed response rate | 26% (95% CI: 12-43) | 28% (95% CI: 14-46) |
| No. of responders | 9 | 10 |
| CR | 0 | 1 |
| VGPR | 5 | 3 |
| PR | 4 | 6 |
| MR | 8 | 5 |
| SD | 12 | 11 |
| PD | 3 | 8 |
| NE | 3 | 1 |
| Median time to response | 1 mo (range: 0.8-3.9) | 1.7 mo (range: 0.9-7.2) |
| Overall survival* | NA | NA |
| Event free at 6 mo, % | 78% (95% CI: 65-94) | 67% (95% CI: 52-86) |
| Progression-free survival* | 6.5 mo (95% CI: 3.9-8.9) | 3.2 mo (95% CI: 1.9-8.6) |
| Event free at 6 mo, % | 56% (95% CI: 41-75) | 34% (95% CI: 21-55) |
CI indicates confidence interval; CR, complete response; VGPR, very good partial response; PR, partial response; MR, minor response; SD, stable disease; PD, progressive disease; NE, not evaluable; and NA, not attained.
Kaplan-Meier.