Eflornithine + Sulindac Shows No Benefit in Adenomatous Polyposis

TUESDAY, Sept. 15, 2020 -- For patients with familial adenomatous polyposis, the incidence of disease progression is not statistically significantly lower with the combination of eflornithine and sulindac versus either eflornithine or sulindac alone, according to a study published in the Sept. 10 issue of the New England Journal of Medicine.

Carole A. Burke, M.D., from the Cleveland Clinic, and colleagues examined the efficacy and safety of the combination of eflornithine and sulindac compared with either drug alone for adults with familial adenomatous polyposis. One hundred seventy-one patients were randomly assigned to eflornithine, sulindac, or both once daily for up to 48 months.

The researchers found that disease progression occurred in 32, 38, and 40 percent of patients in the eflornithine-sulindac, sulindac, and eflornithine groups, respectively (hazard ratios, 0.71 for eflornithine-sulindac versus sulindac and 0.66 for eflornithine-sulindac versus eflornithine). The corresponding values in the treatment groups were similar for precolectomy patients, for patients with rectal or ileal pouch polyposis, and for patients with duodenal polyposis.

"Additional studies that focus on clinical end points in the lower gastrointestinal tract are warranted to better understand the potential of this combination therapy for pharmacologic prevention in specific groups of patients with familial adenomatous polyposis, especially those who have not yet undergone prophylactic colectomy," the authors write.

The study was funded by Cancer Prevention Pharmaceuticals.

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Posted: September 2020