Table 2.
Patient Outcomes (N = 53)
| Outcome | Estimate |
|||
|---|---|---|---|---|
| No. | % | Range | 95% CI | |
| Best objective response | ||||
| Evaluable* | 49 | 100 | ||
| Too early/not evaluable | 4 | |||
| CR | 0 | |||
| PR | 9 | 18 | ||
| Stable disease | 25 | 51 | ||
| Disease progression | 15 | 31 | ||
| Confirmed CR/PR | 6 | |||
| Time to progression, months | ||||
| Median† | 4.4 | 3.0 to 7.8 | ||
| Progressions | 46 | |||
| Progression-free, months | ||||
| 3 | 62 | 50-76 | ||
| 6 | 43 | 32-59 | ||
| 12 | 21 | 12-36 | ||
| 18 | 10 | 4-245 | ||
| 24 | 6 | 3-21 | ||
| Survival, months | ||||
| Median† | 9.9 | 7.2 to 13.6 | ||
| Deaths | 44 | |||
| Alive, months | ||||
| 3 | 87 | 78-96 | ||
| 6 | 70 | 59-83 | ||
| 12 | 40 | 28-55 | ||
| 18 | 19 | 10-35 | ||
| 24 | 16 | 8-32 | ||
| Time to treatment failure, months | ||||
| Median† | 3.6 | 2.8 to 4.8 | ||
| Failures | 50 | |||
| On study, months | ||||
| 3 | 59 | 47-73 | ||
| 6 | 32 | 22-48 | ||
| 12 | 11 | 5-24 | ||
| 18 | 6 | 2-17 | ||
| 24 | 6 | 2-17 | ||
Abbreviations: CR, complete response; PR, partial response.
*
Eligible patients having begun treatment and having at least one post-baseline disease assessment.
†
Kaplan-Meier method.