Patient characteristics by treatment arm
| Characteristic | All | CXB+DFMO | CXB+PBO | p Value |
|---|---|---|---|---|
| N (%) | N (%) | N (%) | ||
| All patients | 112 (100) | 57 (100) | 55 (100) | |
| Age—median (min–max) | 38 (18–63) | 38 (19–59) | 38 (18–63) | 0.89 |
| Sex | 0.84 | |||
| Male | 60 (54) | 30 (53) | 30 (55) | |
| Female | 52 (46) | 27 (47) | 25 (45) | |
| Race | 0.62 | |||
| White | 95 (85) | 49 (86) | 46 (84) | |
| Hispanic | 11 (10) | 4 (7) | 7 (13) | |
| Black | 1 (1) | 1 (2) | 0 (0) | |
| Other | 5 (4) | 3 (5) | 2 (4) | |
| Institution | 0.91 | |||
| Site 1 | 63 (56) | 31 (54) | 32 (58) | |
| Site 2 | 27 (24) | 14 (25) | 13 (24) | |
| Site 3 | 22 (20) | 12 (21) | 10 (18) | |
| Basis of FAP diagnosis | 0.36 | |||
| >100 polyps | 44 (39) | 23 (40) | 21 (38) | |
| >10 polyps and age <40 | 51 (46) | 23 (40) | 28 (51) | |
| >25 polyps and age >40 | 17 (15) | 11 (19) | 6 (11) | |
| Colon vs rectum | 0.17 | |||
| Colon | 46 (41) | 27 (47) | 19 (35) | |
| Rectum only | 66 (59) | 30 (53) | 36 (65) | |
| Number of patients with baseline screen | 108 (100) | 57 (100) | 51 (100) | |
| Number of landmark polyps at baseline screen | 0.20 | |||
| 0–1 | 8 (7) | 5 (9) | 3 (5) | |
| 2–4 | 19 (17) | 12 (21) | 7 (13) | |
| 5–9 | 40 (36) | 21 (37) | 19 (35) | |
| 10 or more | 41 (37) | 19 (33) | 22 (40) | |
| Number of landmark polyps at least 2 mm at baseline screen | 0.05 | |||
| 0–1 | 33 (29) | 20 (35) | 13 (24) | |
| 2–4 | 35 (31) | 23 (40) | 12 (22) | |
| 5–9 | 30 (27) | 8 (14) | 22 (40) | |
| 10 or more | 10 (9) | 6 (11) | 4 (7) | |
| Number of landmark polyps at least 2 mm at baseline screen for evaluable polyps in evaluable patients* | 0.39 | |||
| 0–1 | 22 (32) | 13 (37) | 9 (27) | |
| 2–4 | 24 (35) | 13 (37) | 11 (33) | |
| 5–9 | 18 (26) | 5 (14) | 13 (39) | |
| 10 or more | 4 (6) | 4 (11) | 0 (0) |
Every patient met the eligibility requirements for polyp count; however, those polyps were not required to be in matched landmark areas.
*To be evaluable, patients had to (1) have matching polyp data at baseline and 6 months as well as (2) have completed at least 80% of the treatment both overall and for the final 60 days.
CXB, celecoxib; DFMO, difluoromethylornithine; FAP, familial adenomatous polyposis; PBO, placebo.