Table 2.
Baseline characteristics of the patients included in the RCTs
| IMPACT | QUASAR | Schippinger et al. | MOSAIC | NSABP C07 | ||||||
|---|---|---|---|---|---|---|---|---|---|---|
| FU + LV | Control | FU + LV | Control | 5‐FU/LV | Control | FOLFOX4 | LV5FU2 | FOLFOX | FU + LV | |
| 5‐year DFS Stage II | 0.77 | 0.74 | 0.80 | 0.77 | 0.85 | 0.80 | 0.83 | 0.80 | 0.83 | 0.80 |
| Stage | ||||||||||
| I | 0 (0) | 0 (0) | 8 (1) | 8 (1) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| II | 507 (100) | 509 (100) | 1,483 (91) | 1,480 (91) | 252 (100) | 248 (100) | 451 (40) | 448 (40) | 360 (29) | 359 (29) |
| III | 0 (0) | 0 (0) | 131 (8) | 129 (8) | 0 (0) | 0 (0) | 672 (60) | 675 (60) | 884 (71) | 878 (71) |
| Site | ||||||||||
| Colon | 507 (100) | 509 (100) | 1,148 (71) | 1,143 (71) | 252 (100) | 248 (100) | NR | NR | 1,247 (100) | 1,245 (100) |
| Left | 256 (50) | 280 (55) | NR | NR | 122 (48) | 124 (50) | NR | NR | 247 (20) | 263 (21) |
| Right | 236 (47) | 220 (43) | NR | NR | 130 (52) | 124 (50) | NR | NR | 576 (46) | 507 (41) |
| Recto sigmoid | NR | NR | NR | NR | NR | NR | NR | NR | 412 (33) | 459 (37) |
| Multiple | 6 (1) | 3 (1) | NR | NR | NR | NR | NR | NR | 10 (1) | 15 (1) |
| Unknown | 9 (2) | 6 (1) | NR | NR | NR | NR | NR | NR | 0 (0) | 0 (0) |
| Rectum | 0 (0) | 0 (0) | 474 (29) | 474 (29) | 0 (0) | 0 (0) | NR | NR | 0 (0) | 0 (0) |
| Gender | ||||||||||
| Male | 272 (54) | 287(56) | 1,006 (62) | 973 (60) | 137 (54.4) | 134 (54.0) | 630 (56) | 588 (52) | 690 (55.3) | (58) |
| Age | 61 (22–79) | 62 (26–86) | 63 (23–84) | 63 (23–86) | 65 (29–79) | 65 (30–80) | 61 (NR) | 60 (NR) | 59 (NR) | 59 (NR) |
| pT stage | ||||||||||
| T2 | 0 (0) | 0 (0) | NR | NR | 0 (0) | 0 (0) | 51 (4) | 54 (5) | NR | NR |
| T3 | 429 (85) | 437 (86) | NR | NR | 217 (86) | 214 (86) | 853 (76) | 852 (76) | NR | NR |
| T4 | 9 (1) | 6 (1) | NR | NR | 35 (14) | 34 (14) | 213 (20) | 208 (19) | NR | NR |
| Unknown | 69 (14) | 6 (13) | NR | NR | 0 (0) | 0 (0) | 0 (0) | 0 (0) | NR | NR |
| Tumor differentiation | ||||||||||
| Moderate/well | 432 (85) | 421 (83) | NR | NR | NR | NR | 934 (83) | 914 (81) | NR | NR |
| Poor | 51 (10) | 63 (12) | NR | NR | NR | NR | 141 (13) | 148 (13) | NR | NR |
| Other | 8 (2) | 10 (2) | NR | NR | NR | NR | 0 (0) | 0 (0) | NR | NR |
| Unknown | 16 (3) | 15 (3) | NR | NR | NR | NR | 47 (4) | 61 (5) | NR | NR |
| Perforation present | NR | NR | NR | NR | NR | NR | 77 (7) | 77 (7) | NR | NR |
| Bowel obstruction | NR | NR | NR | NR | NR | NR | 201 (18) | 217 (19) | NR | NR |
Baseline characteristics of Stage II patients were not reported separately in most of the included trials. For these studies, the table shows the baseline characteristics of all patients included in the trial. Data are presented as numbers (%) except for 5‐year DFS and age. For DFS, data were presented as proportion disease‐free. For age, data were presented as mean (range).
Abbreviations: DFS, disease‐free survival; FOLFOX, regimen that includes the drugs leucovorin, fluoropyrimidine and oxaliplatin; FU, fluoropyrimidine; LV, leucovorin; m, months; NR, not reported.