TABLE 2.
Antitumor Activity Outcomes
| Outcome | Liposomal Irinotecan (n = 229) | Topotecan (n = 232) |
|---|---|---|
| Best overall response, No. (%) | ||
| Complete response | 12 (5.2) | 7 (3.0) |
| Partial response | 89 (38.9) | 43 (18.5) |
| Stable disease | 68 (29.7) | 98 (42.2) |
| Progressive disease | 28 (12.2) | 50 (21.6) |
| Not evaluable | 29 (12.7) | 32 (13.8) |
| Undefined | 3 (1.3) | 2 (0.9) |
| ORR, % (95% CI) | ||
| CR + PR | 44.1 (37.6 to 50.8) | 21.6 (16.4 to 27.4) |
| Difference in ORR | 22.3 (14.0 to 30.6); nominal P < .0001 | |
| DoR, months | ||
| Median (95% CI) | 4.1 (3.1 to 4.3) | 4.2 (2.9 to 4.8) |
Abbreviations: CR, complete response; DoR, duration of response; ORR, objective response rate; PR, partial response.