Table 3.
Objective response rate and disease control rate in patients with evaluable treatment response data (N = 49)
| Cohort A (n = 35) | Cohort B (n = 14) | |
|---|---|---|
| Best overall response, n (%) | ||
| Complete response | 1 (2.9) | — |
| Partial response | 5 (14.3) | 1 (7.1) |
| Stable disease | 25 (71.4) | 9 (64.3) |
| Progressive disease | 4 (11.4) | 4 (28.6) |
| Objective response ratea, n (%) | 6 (17.1) | 1 (7.1) |
| 95% CIb | 8.1-32.7 | 1.3-31.5 |
| Disease control ratec, n (%) | 31 (88.6) | 10 (71.4) |
| 95% CIb | 74.1-95.5 | 45.4-88.3 |
| Progression-free survival, months | ||
| Median | 6.3 | 6.0 |
| 95% CId | 5.5-15.6 | 2.0-8.0 |
| Overall survival, months | ||
| Median | 15.1 | NR |
| 95% CId | 10.7-NR | 6.5-NR |
| Survival probability at 6 months | 0.886 | 0.857 |
CI, confidence interval; CR, complete response; NR, not yet reached; PR, partial response; SD, stable disease.
a
Objective response rate = best overall response (CR or PR).
b
95% confidence interval calculated using Wilson's method.
c
Disease control rate = best overall response (CR, PR or SD).
d
95% confidence interval calculated using the Kaplan–Meier method.