Table 2.
Tumor response to treatment with motesanib
| Criteria and response | All patients (N = 138) | Per-protocol analysis seta (N = 120) | RECIST/Choi evaluable patients (N = 102) | 18FDG-PET evaluable patients (N = 91) |
|---|---|---|---|---|
| RECIST | ||||
| Confirmed RECIST response, n (%) | 3 (2) | 3 (3) | 3 (3) | 3 (3) |
| 95% CI | 0.5–6.2 | 0.5–7.1 | 0.6–8.4 | 0.7–9.3 |
| Confirmed partial response, n (%) | 3 (2) | 3 (3) | 3 (3) | 3 (3) |
| Stable disease, n (%) | 70 (51) | 60 (50) | 60 (59) | 55 (60) |
| Durable stable disease ≥24 weeks, n (%) | 19 (14) | 14 (12) | 14 (14) | 14 (15) |
| Progressive disease, n (%) | 43 (31) | 39 (33) | 39 (38) | 33 (36) |
| Not assessed, n (%)b | 22 (16) | 18 (15) | 0 (0) | 0 (0) |
| 18FDG-PET at week 8c | ||||
| Objective response, n (%) | 28 (20) | 27 (23) | – | 27 (30) |
| 95% CI | 13.9–28.0 | 15.4–31.0 | 20.5–40.2 | |
| Nonresponse, n (%) | 110 (80) | 93 (78) | – | 64 (70) |
| 95% CI | 72.0–86.1 | 69.0–84.6 | 59.8–79.5 | |
| Choi criteria at week 8d | ||||
| Objective response, n (%) | 45 (33) | 42 (35) | 42 (41) | – |
| 95% CI | 24.9–41.1 | 26.5–44.2 | 31.5–51.4 | |
| Nonresponse, n (%) | 93 (67) | 78 (65) | 60 (59) | – |
| 95% CI | 58.9–75.1 | 55.8–73.5 | 48.6–68.5 | |
aAll patients who received at least one dose of motesanib and who had prestudy disease progression per RECIST as assessed by independent review
bEnded motesanib treatment prior to the first scheduled assessment of response
cDefined as >25% decrease in average standardized uptake value (SUVmax) in all RECIST target lesions compared with the average SUVmax in all RECIST target lesions at baseline (measured by independent reviewer)
dDefined as ≥10% decrease in the sum of the longest diameter of the target lesions (identified by RECIST) and/or ≥15% decrease in the average target tumor density using the RECIST target lesions compared with the average baseline density based on CT scans