Colon Cancer Prevention Studies with Nonselective NSAIDs

Throughout the 1990s, data from cancer epidemiology strongly supported a role for NSAIDs in colorectal cancer prevention. Large studies found that frequent NSAID use was associated with an approximately 50% reduction in prema-lignant adenomas, carcinomas, and even death due to colorectal cancer (Hawk et al. 2004). Animal colon cancer models, both genetic and carcinogen-induced, also showed this relationship. Dr. Waddell's initial observation was confirmed in prospective randomized trials of sulindac for management of patients with FAP (Giardiello et al. 1993; Labayle et al. 1991). These studies documented treatment-associated regression of pre-existing adenomas in FAP patients using sulindac, with this response achieved in approximately 30% of patients over 6 months of treatment. The next goal was to apply this finding to prevention of sporadic disease. Unfortunately, sulindac was poorly tolerated during long-term administration, with many patients experiencing gastrointestinal upset and even episodes of gastric ulceration and bleeding. Because of its better overall tolerance, aspirin was chosen for prevention trials in patients with sporadic colorectal adenomas. Three prospective randomized trials of aspirin have been completed. Overall, these show a roughly 20% reduction in incidence of newly detected colorectal adenomas in patients with a prior history of colorectal adenomas or colorectal cancer (Baron et al. 2002; Benamouzig et al. 2003; Sandler et al. 2003) One study, involving approximately 1,100 patients with sporadic adenomas, showed a significant decrease in recurrent adenomas in a low-dose aspirin arm (81 mg per day; relative risk, 0.81, 95% confidence interval, 0.69;0.96), but not a high-dose aspirin arm (325 mg per day; relative risk, 0.96; 95% confidence interval, 0.81;1.13) (Baron et al. 2002). Nevertheless, the general agreement between these three studies combined with strong epidemiological data led researchers to conclude that aspirin effectively prevented a subset of sporadic colorectal adenomas.

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