Table 1.
Baseline characteristics and demographics
| XELOX or FOLFOX vs leucovorin and fluorouracil monotherapy |
Capecitabine with or without oxaliplatin vs leucovorin and fluorouracil with or without oxaliplatin |
XELOX vs capecitabine | ||||
|---|---|---|---|---|---|---|
| Leucovorin and fluorouracil (n=1921)* |
XELOX or FOLFOX (n=2898)† |
Leucovorin and fluorouracil with or without oxaliplatin (n=3877)‡ |
Capecitabine with or without oxaliplatin (n=1942)§ |
Capecitabine (n=1000)¶ |
XELOX (n=942)‖ | |
| Age (years) | 62·0 (22–82) | 59·0 (19–85) | 60·0 (19–85) | 62·0 (22–83) | 62·0 (25–80) | 61·0 (22–83) |
| Sex | ||||||
| Women | 890 (46%) | 1374 (47%) | 1833 (47%) | 891 (46%) | 460 (46%) | 431 (46%) |
| Men | 1031 (54%) | 1524 (53%) | 2044 (53%) | 1051 (54%) | 540 (54%) | 511 (54%) |
| Race | ||||||
| Asian/Pacific Islander | 134 (7%) | 298 (10%) | 310 (8%) | 136 (7%) | 14 (1%) | 122 (13%) |
| Black | 30 (2%) | 97 (3%) | 113 (3%) | 19 (1%) | 5 (1%) | 14 (1%) |
| White | 1734 (90%) | 2447 (84%) | 3400 (88%) | 1756 (90%) | 975 (98%) | 781 (83%) |
| Hispanic | 14 (1%) | 32 (1%) | 28 (1%) | 19 (1%) | 1 (<1%) | 18 (2%) |
| Other | 9 (<1%) | 24 (1%) | 26 (1%) | 12 (<1%) | 5 (1%) | 7 (1%) |
| ECOG performance status | ||||||
| 0 | 1100 (57%) | 2338 (81%) | 2739 (71%) | 1084 (56%) | 385 (39%) | 699 (74%) |
| 1 | 336 (17%) | 551 (19%) | 652 (17%) | 367 (19%) | 132 (13%) | 235 (25%) |
| Unknown | 485 (25%) | 9 (<1%) | 486 (13%) | 491 (25%) | 483 (48%) | 8 (1%) |
| Disease stage | ||||||
| IIIA | 156 (8%) | 297 (10%) | 363 (9%) | 182 (9%) | 92 (9%) | 90 (10%) |
| IIIB | 1146 (60%) | 1505 (52%) | 2130 (55%) | 1124 (58%) | 603 (60%) | 521 (55%) |
| IIIC | 619 (32%) | 1093 (38%) | 1381 (36%) | 636 (33%) | 305 (31%) | 331 (35%) |
| Unknown | 0 | 3 (<1%) | 3 (<1%) | 0 | 0 | 0 |
| Primary tumour classification | ||||||
| T0 | 0 | 1 (<1%) | 1 (<1%) | 0 | 0 | 0 |
| T1 | 36 (2%) | 101 (3%) | 110 (3%) | 39 (2%) | 12 (1%) | 27 (3%) |
| T2 | 161 (8%) | 263 (9%) | 346 (9%) | 168 (9%) | 90 (9%) | 78 (8%) |
| T3 | 1442 (75%) | 2124 (73%) | 2866 (74%) | 1461 (75%) | 761 (76%) | 700 (74%) |
| T4 | 282 (15%) | 407 (14%) | 552 (14%) | 274 (14%) | 137 (14%) | 137 (15%) |
| Carcinoma in situ | 0 | 1 (<1%) | 1 (<1%) | 0 | 0 | 0 |
| Unknown | 0 | 1 (<1%) | 1 (<1%) | 0 | 0 | 0 |
| Regional lymph node classification | ||||||
| N1 | 1302 (68%) | 1805 (62%) | 2496 (64%) | 1306 (67%) | 695 (70%) | 611 (65%) |
| N2 | 619 (32%) | 1093 (38%) | 1381 (36%) | 636 (33%) | 305 (31%) | 331 (35%) |
| Number of lymph nodes examined | ||||||
| ≤12 | 456 (24%) | 1131 (39%) | 1128 (29%) | 459 (24%) | 0 | 459 (49%) |
| >12 | 483 (25%) | 1757 (61%) | 1765 (46%) | 475 (24%) | 0 | 475 (50%) |
| Unknown | 982 (51%) | 10 (<1%) | 984 (25%) | 1008 (52%) | 1000 (100%) | 8 (1%) |
| Time from surgery to relapse (years) | 1·46 (0·05–7·30)** | 1·42 (0·08–7·47)†† | 1·45 (0·05–7·30)‡‡ | 1·44 (0·06–7·47)§§ | -- | -- |
Data are median (range) or n (%) unless otherwise indicated. XELOX=capecitabine plus oxaliplatin. FOLFOX=leucovorin and fluorouracil plus oxaliplatin. ECOG=Eastern Cooperative Oncology Group.
*
982 patients in X-ACT and 939 in XELOXA.
†
942 patients in XELOXA, 1001 in NSABP C-08, and 955 in AVANT.
‡
982 patients in X-ACT, 939 in XELOXA, 1001 in NSABP C-08, and 955 in AVANT.
§
1000 patients in X-ACT and 942 in XELOXA.
¶
X-ACT only.
‖‖
XELOXA only.
**
N=744.
††
N=757.
‡‡
N=1222.
§§
N=659.