Table 2.
Analysis of Secondary End Points
| End Point* | Placebo (n = 47) | Linifanib 7.5 mg (n = 44) | Linifanib 12.5 mg (n = 47) |
|---|---|---|---|
| PFS | |||
| Median, months | 5.4 | 8.3 | 7.3 |
| 95% CI, months | 4.2 to 5.7 | 4.2 to 10.8 | 4.6 to 10.8 |
| HR† | 0.509 | 0.640 | |
| P‡ | .022 | .118 | |
| OS | |||
| Median, months | 11.3 | 11.4 | 13.0 |
| 95% CI, months | 8.8 to 17.0 | 6.6 to 14.8 | 8.3 to 18.9 |
| HR† | 1.075 | 0.888 | |
| P‡ | .779 | .650 | |
| 12-Month survival rate, % | 45 | 44 | 54 |
| 95% CI | 30 to 58 | 29 to 59 | 40 to 68 |
| ORR, % | 25.5 | 43.2 | 31.9 |
| 95% CI | 13.9 to 40.3 | 28.3 to 59.0 | 19.1 to 47.1 |
| P§ | .066 | .500 | |
| Best % change in sum of target lesion sizes | |||
| Median | −14.6 | −37.2 | −35.3 |
| Range | −89.1-27.0 | −100.0-6.7 | −80.5-7.1 |
| DOR, months | |||
| Median | 6.9 | 7.0 | 8.1 |
| 95% CI | 3.0 to NR | 5.6 to 9.6 | 6.8 to NR |
Abbreviations: DOR, duration of response; ECOG Eastern Cooperative Oncology Group; HR, hazard ratio; NR, not reached; ORR, objective response rate; OS, overall survival; PFS, progression-free survival.
*
Analyses of PFS were performed with the 75th PFS event as the cutoff date. Analyses for OS and 12-month survival rate were performed with the 90th death event as the cutoff date.
†
Stratified (by ECOG and sex), Cox proportional hazards model for comparison to placebo group.
‡
Stratified (by ECOG and sex), log-rank test.
§
Stratified (by ECOG and sex), Cochran-Mantel-Haenszel test.