Table 2.
Summary of response data by IRC.
| Response | Primary refractory (n = 35)a |
Acquired resistance (n = 45)a |
Total (N = 83) |
|---|---|---|---|
| Best overall response | |||
| Complete response | 0 | 0 | 0 |
| Partial response | 3 (8.6) | 1 (2.2) | 4 (4.8) |
| Stable disease | 0 | 9 (20.0) | 9 (10.8) |
| Non-complete response/nonprogressive diseaseb | 0 | 2 (4.4) | 2 (2.4) |
| Progressive disease | 25 (71.4) | 28 (62.2) | 54 (65.1) |
| Not evaluablec | 7 (20) | 5 (11.1) | 14 (16.9) |
| Objective response | 3 (8.6; 1.8-23.1) | 1 (2.2; 0.1-11.8) | 4 (4.8; 1.3-11.9) |
| Disease control rate | 3 (8.6; 1.8-23.1) | 12 (26.7; 14.6-41.9) | 15 (18.1; 10.5-28.1) |
Data are n (%), n (%; 95% CI), or median (range or 95% CI), according to IRC-assessed Response Evaluation Criteria in Solid Tumors version 1.1.
aPrimary refractory or acquired resistance status was not available for 3 of the 83 patients.
bNon-complete response/non-progressive disease was defined as the persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits in non-target lesion.
cOf 14 patients, 9 (64.3%) had no tumor review by the IRC.
Abbreviation: IRC, independent review committee.