Table 3.
Summary of the efficacy endpoint analyses
| Study Population, n (%) |
||
|---|---|---|
| Evaluated by ERRC (n = 46) | Evaluated by Local Investigator (n = 63) | |
| Objective responsea, n (%) | ||
| CR | 2 (4.3) | 1 (1.6) |
| PR | 13 (28.3) | 20 (31.7) |
| SD | 19 (41.3) | 26 (41.3) |
| Progressive disease | 12 (26.1) | 15 (23.8) |
| Indeterminate | 0 | 1 (1.6) |
| Objective response ratea, n (%) | 15 (32.6) | 21 (33.3) |
| 95% CI | 19.5–48.0 | 22.0–46.3 |
| Duration of responsea | ||
| Median, wk | 27.0 | 19.1 |
| Range | 7.7–44.1 | 6.9–46.6 |
| TTP parameter | ||
| Event free at 6 mo,b % | 46.2 | 49.6 |
| 95% CI | 31.3–61.0 | 36.7–62.6 |
| Median TTP, mo | 4.3 | 5.6 |
| 95% CI | 2.7–6.4 | 3.8–7.4 |
| TTF parameter | ||
| Event free at 6 mo,b % | 37.0 | 34.9 |
| 95% CI | 23.0–50.9 | 23.1–46.7 |
| Median TTF, mo | 3.4 | 3.8 |
| 95% CI | 2.6–6.1 | 2.9–5.4 |
Abbreviations: TTP, time to tumor progression; TTF, time to treatment failure.
aResponses during the first 4 treatment cycles; in addition, 2 patients had PRs confirmed 21 and 23 days after the initial assessment, thus were considered per definition as unconfirmed PRs.
bFor both TTP and TTF, probability of being event free at 6 mo was calculated using Kaplan–Meier imputation method.