Patients with familial adenomatous polyposis have an inherited gene mutation that results in hundreds of precancerous polyps and almost certain cancer of the colon. Most such patients eventually have their colons removed to prevent the development of cancer, note Dr. Gideon Steinbach, of the University of Texas M.D. Anderson Cancer Center in Houston and his research colleagues.
In light of experimental evidence suggesting that drugs like celecoxib might prevent polyp development, the authors studied the effects of celecoxib in 77 patients with familial adenomatous polyposis.
Twice daily treatment with 400 milligrams of celecoxib brought a 28% reduction in the number of polyps, the authors report, and a 100-mg dose twice daily led to an 11.9% reduction. In contrast, polyp counts in patients who received a placebo, or "dummy" pill, fell by only 4.5%.
More than half the patients in the 400-mg treatment group experienced at least a 25% reduction in the number of colorectal polyps, compared with 31% of the 100-mg group and 7% of the placebo group, the results indicate.
The researchers also measured the width of each polyp and added all the widths to arrive at what they called the "polyp burden." The average polyp burden improved by 30.7% for the 400-mg group and by 14.6% for the 100-mg group, they note. The placebo group experienced only a 4.9% reduction in polyp burden.
Side effects were similar for the three groups, according to the report in the June 29th issue of The New England Journal of Medicine.
"Our findings suggest," the authors conclude, "that celecoxib could serve as an adjunct to current management by suppressing polyp formation in patients with residual rectum after colectomy (surgery to remove the colon) and in patients with an intact colon who are awaiting colectomy."
"Celecoxib is FDA-approved for FAP (familial adenomatous polyposis) as an adjunct to polypectomy. It might also be appropriate treatment for patients who have a rectum with polyps, for patients with disease of the duodenum, and for patients who refuse or decide to delay colon surgery," Steinbach told Reuters Health.
"It has always been our hope that drugs like celecoxib will eventually spare patients the need for colectomy. We're not there yet, but studies are underway to test celecoxib's ability to prevent polyps in adolescents and other patients," he added.
"Our vision for the future is to be able to prevent cancers with simple treatments. This study represents the first step along the road to that goal," he concluded.
SOURCE: The New England Journal of Medicine 2000;342:1946-1952.