Participant characteristics
| Total | Placebo | LD naproxen | HD naproxen | P value | |||||
| N | % | N | % | N | % | N | % | ||
| Total | 54 | 100 | 23 | 42.6 | 15 | 27.8 | 16 | 29.6 | |
| Age | 0.58 | ||||||||
| Mean (SD) | 44 | 12.6 | 43.7 | 14 | 46.4 | 12.7 | 42.3 | 10.8 | |
| Age group | |||||||||
| 20–29 | 10 | 18.4 | 6 | 26.1 | 2 | 13.3 | 2 | 12.5 | 0.81 |
| 30–39 | 9 | 16.7 | 2 | 8.7 | 2 | 13.3 | 5 | 31.3 | |
| 40–49 | 15 | 27.8 | 7 | 30.4 | 4 | 26.8 | 4 | 25.0 | |
| 50–59 | 15 | 27.8 | 6 | 26.1 | 5 | 33.3 | 4 | 25.0 | |
| 60–69 | 4 | 7.4 | 1 | 4.3 | 2 | 13.3 | 1 | 6.3 | |
| 70–70 | 1 | 1.9 | 1 | 4.3 | 0 | 0.0 | 0 | 0.0 | |
| Gender | |||||||||
| Male | 18 | 33.3 | 10 | 43.5 | 5 | 33.3 | 3 | 18.7 | 0.29 |
| Female | 36 | 66.7 | 13 | 56.5 | 10 | 66.7 | 13 | 81.3 | |
| Race | |||||||||
| White | 50 | 92.6 | 22 | 95.7 | 13 | 86.6 | 15 | 93.8 | 0.71 |
| Other | 3 | 5.6 | 1 | 4.3 | 1 | 6.7 | 1 | 6.2 | |
| Unknown | 1 | 1.9 | 0 | 0.0 | 1 | 6.7 | 0 | 0.0 | |
| Ethnicity | |||||||||
| Not Hispanic or Latino | 51 | 94.4 | 23 | 100 | 13 | 86.7 | 15 | 93.8 | 0.06 |
| Hispanic or Latino | 1 | 1.9 | 0 | 0.0 | 0 | 0.0 | 1 | 6.3 | |
| Not Reported | 2 | 3.7 | 0 | 0.0 | 2 | 13.3 | 0 | 0.0 | |
| Type of MMR deficiency | |||||||||
| LLS | 4 | 7.4 | 2 | 8.7 | 1 | 6.7 | 1 | 6.3 | 1 |
| LS positive | 50 | 92.6 | 21 | 91.3 | 14 | 93.3 | 15 | 93.8 | |
| MMR gene | |||||||||
| MLH1 | 18 | 36.0 | 7 | 33.3 | 7 | 50.0 | 4 | 26.7 | 0.2 |
| MSH2 | 16 | 32.0 | 5 | 23.8 | 3 | 21.4 | 8 | 53.3 | |
| MSH6 | 9 | 18.0 | 3 | 14.3 | 4 | 28.57 | 2 | 13.3 | |
| PMS2 | 4 | 8.0 | 4 | 19.0 | 0 | 0.0 | 0 | 0.0 | |
| EPCAM | 3 | 6.0 | 2 | 9.5 | 0 | 0.0 | 1 | 6.7 | |
| History of cancer | |||||||||
| Negative | 29 | 53.7 | 13 | 56.5 | 8 | 53.3 | 8 | 50 | 0.94 |
| Cancer diagnosis | 25 | 46.3 | 10 | 43.5 | 7 | 43.7 | 8 | 50 | |
| Type of cancer (n)* | |||||||||
| CRC | 13 | 5 | 4 | 4 | |||||
| Endometrial | 6 | 1 | 3 | 2 | |||||
| Urothelial | 0 | 0 | 0 | 0 | |||||
| Ovarian | 1 | 1 | 0 | 0 | |||||
| Other | 12 | 4 | 2 | 6 | |||||
| Accrual | |||||||||
| Site | 0.58 | ||||||||
| Brigham | 14 | 25.9 | 5 | 21.7 | 4 | 26.7 | 5 | 31.25 | |
| Huntsman | 6 | 11.1 | 3 | 13.0 | 3 | 20.0 | 0 | 0.0 | |
| MDACC | 17 | 31.5 | 6 | 26.1 | 5 | 33.3 | 6 | 37.5 | |
| Michigan | 17 | 31.5 | 9 | 39.1 | 3 | 20.0 | 5 | 31.25 | |
| Compliance | |||||||||
| Average | |||||||||
| Days on agent | 186.48 | 187.6 | 185.7 | 185.6 | 0.92 | ||||
| (min, max) | 172 to 215 | 180 to 215 | 172 to 203 | 177 to 194 | |||||
| Days missed | 2.71 | 3.15 | 2.7 | 2.09 | 0.87 | ||||
| (min, max) | 0 to 19 | 0 to 16 | 0 to 19 | 0 to 13 | |||||
| Percentage of study drug taken | 94.37 | 94.69 | 94.02 | 94.25 | 0.68 | ||||
| (min, max) | 81.9 to 100 | 81.9 to 100 | 85.9 to 98.9 | 82.3 to 100 | 0.68 | ||||
*Patients can present with more than one cancer type.
CRC, colorectal cancer; HD, high dose; LD, low dose; LLS, Lynch-like syndrome; LS, Lynch syndrome; MMR, mismatch repair.