Table 2.
Tumor response and TTP using WHO criteria and mRECIST
| Cohort A (n = 55) |
Cohort B (n = 46) |
|||
|---|---|---|---|---|
| WHOa | mRECIST | WHOa | mRECIST | |
| Best tumor response, n (%) | ||||
| CR | 1 (1.8) | 5 (9.1) | 0 | 0 |
| PR | 3 (5.5) | 9 (16.4) | 2 (4.3) | 5 (10.9) |
| SD | 24 (43.6) | 29 (52.7) | 18 (39.1) | 28 (60.9) |
| Response rateb,% (n/N) | 7.3 (4/55) | 25.5 (14/55) | 4.3 (2/46) | 10.9 (5/46) |
| DCRc,% (n/N) | 50.9 (28/55)d | 78.2 (43/55)e | 43.5 (20/46) | 71.7 (33/46)f |
| Number progressed/number treated patients | 34/55 | 18/55 | 30/46 | 14/46 |
| Median TTP (months) (95% CI) | 2.8 (1.4-3.5) | 5.4 (2.8-NR) | 1.4 (1.4-2.7) | 6.9 (3.9-NR) |
Cohort A: brivanib alaninate 800 mg once daily and no prior systemic therapy; Cohort B: brivanib alaninate 800 mg once daily and prior systemic therapy.
a
Independent Response Review Committee assessment.
b
Response rate = CR + PR.
c
Disease control rate = CR + PR + uCR + uPR + SD.
d
DCR includes 2 uPRs.
e
DCR includes 2 uCRs and 3 uPRs.
f
DCR includes 1 uPR. uCR=unconfirmed complete response; uPR=unconfirmed partial response; NR=not reached.