Table 1.
Demographic and Clinical Characteristics of the Patients at Baseline (Per-Protocol Population).*
| Characteristic | FOLFOX Group (N = 585) | Chemoradiotherapy Group (N = 543) |
|---|---|---|
| Age — yr | ||
| Mean | 57.3±10.9 | 57.0±11.1 |
| Median (range) | 57 (19–91) | 57 (25–84) |
| Sex — no. (%) | ||
| Female | 216 (36.9) | 173 (31.9) |
| Male | 369 (63.1) | 370 (68.1) |
| Race — no. (%)† | ||
| White | 492 (84.1) | 467 (86.0) |
| Black | 32 (5.5) | 17 (3.1) |
| Asian | 31 (5.3) | 19 (3.5) |
| Other or not reported | 30 (5.1) | 40 (7.4) |
| Hispanic or Latino ethnic group† | ||
| Yes | 48 (8.2) | 48 (8.8) |
| No | 516 (88.2) | 475 (87.5) |
| Unknown or not reported | 21 (3.6) | 20 (3.7) |
| Country of residence — no. (%) | ||
| Canada | 51 (8.7) | 45 (8.3) |
| Switzerland | 10 (1.7) | 9 (1.7) |
| United States | 524 (89.6) | 489 (90.1) |
| Body-mass index‡ | ||
| Mean | 29.3±6.0 | 29.1±6.7 |
| Median (range) | 28.4 (14.5–65.4) | 28.1 (15.8–81.4) |
| Distribution — no. (%) | ||
| <18.5 | 4 (0.7) | 6 (1.1) |
| ≥18.5 to <25 | 127 (21.7) | 139 (25.6) |
| ≥25 to <30 | 225 (38.5) | 200 (36.8) |
| ≥30 | 229 (39.1) | 198 (36.5) |
| History of diabetes — no. (%) | ||
| Yes | 81 (13.8) | 83 (15.3) |
| No | 504 (86.2) | 460 (84.7) |
| History of cardiovascular disease — no. (%) | 106 (18.1) | 98 (18.0) |
| Starting neoadjuvant treatment — no. (%) | 479 (81.9) | 445 (82.0) |
| Highest education level — no./total no. (%) | ||
| Less than high school | 29/568 (5.1) | 29/531 (5.5) |
| High school diploma or GED certificate | 214/568 (37.7) | 201/531 (37.9) |
| Some college | 119/568 (21.0) | 102/531 (19.2) |
| College degree or higher | 206/568 (36.3) | 199/531 (37.5) |
| ECOG performance-status score — no. (%)§ | ||
| 0 or 1 | 582 (99.5) | 540 (99.4) |
| 2 | 3 (0.5) | 3 (0.6) |
| Primary rectal tumor on digital examination — no./total no. (%) | ||
| Rectal tumor not palpable | 290/580 (50.0) | 259/536 (48.3) |
| Rectal tumor palpable | 290/580 (50.0) | 277/536 (51.7) |
| Rectal tumor location — cm from anal verge | ||
| No. of patients with data | 585 | 542 |
| Mean | 8.6±2.9 | 8.5±2.8 |
| Median (range) | 8 (2–25) | 8 (2–18) |
| Rectal tumor location — no. (%) | ||
| ≤5 cm from anal verge | 83 (14.2) | 90 (16.6) |
| >5 to ≤10 cm from anal verge | 375 (64.1) | 344 (63.4) |
| >10 cm from anal verge | 127 (21.7) | 109 (20.1) |
| Clinical stage — no./total no. (%) | ||
| T2 node positive | 63/584 (10.8) | 38/543 (7.0) |
| T3 node negative | 232/584 (39.7) | 198/543 (36.5) |
| T3 node positive | 289/584 (49.5) | 307/543 (56.5) |
| Staging performed with MRI — no. (%) | ||
| Yes | 494 (84.4) | 458 (84.3) |
| No | 91 (15.6) | 85 (15.7) |
Plus–minus values are means ±SD. The per-protocol population included all the patients who received any dose of treatment. FOLFOX consists of fluorouracil, leucovorin, and oxaliplatin; the chemoradiotherapy used in the trial consisted of pelvic radiation therapy plus sensitizing chemotherapy with a fluoropyrimidine. Patients in the FOLFOX group received six cycles of FOLFOX, with chemoradiotherapy given only if the primary tumor decreased in size by less than 20% or if FOLFOX was discontinued because of side effects; patients in the chemoradiotherapy group received chemoradiotherapy alone. Percentages may not total 100 because of rounding. GED denotes General Educational Development.
Race and ethnic group were reported by the patients.
The body-mass index is the weight in kilograms divided by the square of the height in meters. Three patients had large values (>65), two as a result of an unusually short height (≤108 cm) and one because of an unusually high weight (205 kg). The sites confirmed that these data were correct.
Eastern Cooperative Oncology Group (ECOG) performance-status scores range from 0 to 5, with higher scores indicating greater disability.