Table 1.
Baseline patient characteristics
| Characteristics | Overall (n = 1179) |
|---|---|
| Demographic factors | |
| Age, mean (SD), y | 60.8 (10.5) |
| Sex, No. (%) | |
| Male | 658 (55.8) |
| Female | 521 (44.2) |
| Race, No. (%) | |
| Asian | 34 (2.9) |
| Black or African American | 131 (11.1) |
| Hispanic or Latino, No. (%) | 65 (5.5) |
| Others or not reported | 41 (3.5) |
| White | 973 (82.5) |
| Clinical factors | |
| Extent of invasion through the bowel wall, No. (%)a | |
| T1 or T2 | 230 (19.6) |
| T3 | 775 (66.1) |
| T4 | 167 (14.3) |
| Missing | 7 |
| Nodal stage, No. (%)b | |
| N1 | 871 (73.9) |
| N2 | 308 (26.1) |
| Risk group, No. (%) | |
| Low (T1, T2, or T3, N1) | 753 (64.2) |
| High (T4, N2, or both) | 419 (35.8) |
| Missing | 7 |
| Tumor location, No. (%) | |
| Left | 576 (49.3) |
| Right | 588 (50.3) |
| Multiple | 5 (0.4) |
| Missing | 10 |
| Eastern Cooperative Oncology Group performance status, No. (%)c | |
| 0 | 852 (72.3) |
| 1-2 | 327 (27.7) |
| Low dose aspirin use, No. (%) | 277 (23.5) |
| Behavioral factorsd | |
| Body mass index, mean (SD), kg/m2 | 28.4 (6.8) |
| Smoking history, No. (%) | |
| Never | 586 (49.7) |
| Former | 490 (41.6) |
| Current | 91 (7.7) |
| Not reported | 12 (1.0) |
| Western dietary pattern score, median (IQR) | −0.21 (−0.64-0.42) |
| Prudent dietary pattern score, median (IQR) | −0.07 (−0.56-0.41) |
| Physical activity, mean (SD), metabolic equivalent h/wk, | 15.6 (23.5) |
| Randomization groups | |
| Chemotherapy, No. (%) | |
| 3 mo | 603 (51.1) |
| 6 mo | 576 (48.9) |
| Pharmacotherapy, No. (%) | |
| Celecoxib | 598 (50.7) |
| Placebo | 581 (49.3) |
| Inflammatory biomarker concentrations | |
| High-sensitivity C-reactive protein, median (IQR), mg/L | 2.6 (1.2-5.7) |
| ≥3.0 mg/L, No. (%) | 524 (44.4) |
| Interleukin 6, median (IQR), pg/mL, | 3.7 (2.3-6.2) |
| Soluble tumor necrosis factor-α receptor 2, median (IQR) , pg/L | 2870 (2338-3603) |
T1 indicates tumor has grown into the submucosa; T2, growth into the muscularis propria; T3, growth through the muscularis propria and into the subserosa; T4, growth into the surface of the visceral peritoneum or into or has attached to other organs or structures. IQR = interquartile range.
N1 indicates 1-3 lymph nodes tested positive for cancer (or for this table, N1c: tumor deposit(s) in the subserosa, mesentery, or nonperitonealized pericolic or perirectal tissues without regional lymph node metastases); N2, 4 or more lymph nodes tested positive for cancer.
Performance status: 0 indicates fully active; 1, restricted in physically strenuous activity but ambulatory and able to carry out light work; and 2, ambulatory and capable of all self-care but unable to carry out any work activities, up and about more than 50% of waking hours.
Body mass index, Western dietary pattern, prudent dietary pattern, and physical activity were calculated using the cumulative average method.