Table 3.
End Point | Trabectedin (n = 345) | Dacarbazine (n = 173) | HR/OR (95% CI)* | P |
---|---|---|---|---|
PFS, months | 4.2 | 1.5 | 0.55 (0.44 to 0.70) | < .001 |
TTP, months | 4.2 | 1.5 | 0.52 (0.41 to 0.66) | < .001 |
No. (%) of ORR | 34 (9.9) | 12 (6.9) | 1.47 (0.72 to 3.2) | .33 |
DOR, months | 6.5 | 4.2 | 0.47 (0.17 to 1.32) | .14 |
No. (%) with SD as best response | 177 (51) | 60 (35) | — | — |
Duration of SD, months | 6.01 | 4.17 | 0.45 (0.30 to 0.67) | < .001 |
% of CBR | 34 | 19 | 2.3 (1.45 to 3.7) | < .001 |
Abbreviations: CBR, clinical benefit rate; DOR, duration of response; HR, hazard ratio; OR, odds ratio; ORR, objective response rate; PFS, progression-free survival; SD, stable disease; TTP, time to progression..
The HR was calculated as the hazard in the trabectedin treatment group, divided by the hazard in the dacarbazine treatment group.