Table 2.
Summary of the most important data from clinical trials of NSAIDs in colorectal cancer chemoprevention.
| Clinical Trial, Source, Year | Study Drug | Number of Patients, n | Drug Dose, Treatment Period |
Population | Endpoint | Result |
|---|---|---|---|---|---|---|
| CAPS, [74], 2003 | ASA | 635 (317—ASA; 318—placebo) |
ASA 325 mg for 3 years |
patients with a history of colorectal cancer without relapse for at least 5 years after tumor resection; age 30–80 years | at least one colon adenoma in the study group vs. control group | RR = 0.65 95% CI (0.46–0.91) |
| APACC, [75], 2012 | Lysine acetylsalicylate (soluble acetylsalicylic salt) | 272 (73—lower dose of ASA; 67—higher dose of ASA; 132—placebo) |
ASA 160 mg or 300 mg for 4 years | patients with a history of sporadic colon adenomas; age 18–75 years | at least one colon adenoma in the study group vs. control group after one year | RR = 0.73 95% CI (0.52–1.04) |
| and after four years | RR = 0.96 95% CI (0.75-1.22) |
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| Ishikawa et al. [76], 2014 | ASA | 311 (152—ASA; 159—placebo) |
ASA 100 mg for 2 years |
patients with single or multiple adenomas and/or colorectal adenocarcinomas, originating from Japan; age 40–70 years | frequency of relapse in the study group vs. control group | OR = 0.60 95% CI (0.36–0.98) |
| CAPP2, [77], 2020 | ASA; resistant starch | 861 (427—ASA; 434—placebo) |
ASA 600 mg; resistant starch 30 g for at least 2 years |
patients with Lynch syndrome; min age 45 years | colorectal cancer onset | HR = 0.65 95% CI (0.43–0.97) |
| Giardiello et al. [78], 2002 | Sulindac | 41 (21—Sulindac; 20—placebo) |
2 × 150 mg or 2 × 75 mg for 4 years |
young patients with FAP; age 8–25 years | colon adenomas | no positive results; adenomas developed in 43% of patients on sulindac and 55% of patients on placebo |
| PreSAP, [79], 2006 | Celecoxib | 1561 (933—Celecoxib; 628—placebo) |
Celecoxib 400 mg daily for 3 years |
patients with a history of sporadic colon adenomas; age > 30 years |
at least one colon adenoma in the study group vs. control group | RR = 0.64 95% CI (0.56–0.75) |
| detection of advanced adenomas | RR = 0.49 95% CI (0.33–0.73) |
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| APC, [80], 2006 | Celecoxib | 2035 (679—higher dose of Celecoxib; 685—lower dose of Celecoxib; 671—placebo) |
2 × 200 mg or 2 × 400 mg of Celecoxib daily for 3 years |
patients with a history of sporadic colon adenomas; age 31–88 years |
at least one colon adenoma in the study group vs. control group | in a group on a lower dose: RR = 0.67 95% CI (0.59–0.77); in a group on a higher dose: RR = 0.45 95% CI (0.33–0.63) |
| advanced adenomas | in a group on a lower dose: RR = 0.43 95% CI (0.31–0.61); in a group on a higher dose: RR = 0.34 95% CI (0.24–0.50) |
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| CHIP, [81], 2017 | Celecoxib | 106 (55—Celecoxib; 51—placebo) |
weight-dependent dose: 2 × 200 mg (25.0–37.5 kg); 2 × 300 mg (37.6–50.0 kg); 2 × 400 mg (>50.0 kg) for max. 5 years |
young patients with FAP; age 10–17 years |
time to disease progression (TDP), defined as development of 20 polyps or more >2 mm by colonoscopy | median in the study group—2.1 years; median in the control group—1.1 years |
| the percentage of patients with progression | 12.7% of patients in the study group and 25.5% of patients in the control group |
RR: relative risk, OR: odds ratio, HR: hazard ratio, CI: confidence interval.