Parameter | Better efficacy subgroup | ITT population | ||
---|---|---|---|---|
FOLFIRI-Placebo | FOLFIRI-Aflibercept | FOLFIRI-Placebo | FOLFIRI-Aflibercept | |
(n = 406) | ( n = 404) | ( n = 614) | ( n = 612) | |
Gender, n (%) | ||||
Female | 174 (42.9) | 153 (37.9) | 261 (42.5) | 247 (40.4) |
Male | 232 (57.1) | 251 (62.1) | 353 (57.5) | 365 (59.6) |
Mean age, y (range) | 59.9 (25–86) | 59.4 (21–82) | 60.2 (19–86) | 59.5 (21–82) |
Age group, n (%) | ||||
<65 y | 254 (62.6) | 277 (68.6) | 376 (61.2) | 407 (66.5) |
≥65 but <75 y | 133 (32.8) | 108 (26.7) | 199 (32.4) | 172 (28.1) |
≥75 y | 19 (4.7) | 19 (4.7) | 39 (6.4) | 33 (5.4) |
Race, n (%) | ||||
Asian | 29 (7.1) | 23 (5.7) | 51 (8.3) | 35 (5.7) |
Black | 14 (3.4) | 11 (2.7) | 27 (4.4) | 16 (2.6) |
White | 355 (87.4) | 361 (89.4) | 523 (85.2) | 548 (89.5) |
Other | 8 (2) | 9 (2.2) | 13 (2.1) | 13 (2.1) |
Cancer diagnosis category, n (%) | ||||
Colon | 187 (46.1) | 188 (46.5) | 302 (49.2) | 289 (47.2) |
Rectosigmoid | 95 (23.4) | 85 (21) | 136 (22.1) | 123 (20.1) |
Rectum | 123 (30.3) | 129 (31.9) | 174 (28.3) | 197 (32.2) |
Other | 1 (0.2) | 2 (0.5) | 2 (0.3) | 3 (0.5) |
Number of organs with metastasis, n (%) | ||||
0 | 2 (0.5) | 2 (0.5) | 6 (1.0) | 2 (0.3) |
1 | 237 (58.4) | 230 (56.9) | 271 (44.1) | 256 (41.8) |
>1 | 167 (41.1) | 172 (42.6) | 337 (54.9) | 354 (57.8) |
Metastatic sites, n (%) | ||||
Liver | 283 (69.7) | 294 (72.8) | 431 (70.2) | 459 (75.0) |
Lung | 160 (39.4) | 152 (37.6) | 277 (45.1) | 271 (44.3) |
Lymph | 88 (21.7) | 100 (24.8) | 181 (29.5) | 173 (28.3) |
Liver metastasis only, n (%) | 134 (33) | 141 (34.9) | 146 (23.8) | 153 (25.0) |
ECOG performance status, n (%) | ||||
0 | 314 (77.3) | 317 (78.5) | 350 (57.0) | 349 (57.0) |
1 | 92 (22.7) | 87 (21.5) | 250 (40.7) | 250 (40.8) |
2 | 0 | 0 | 14 (2.3) | 13 (2.1) |
Prior bevacizumab, n (%) | ||||
Yes | 133 (32.8) | 132 (32.7) | 187 (30.5) | 186 (30.4) |
No | 273 (67.2) | 272 (67.3) | 427 (69.5) | 426 (69.6) |