TUESDAY, March 22, 2016 (HealthDay News) -- For patients with familial adenomatous polyposis (FAP), treatment with a combination of sulindac and erlotinib is associated with significant reductions in the number and diameter of polyps, according to a study published in the March 22/29 issue of the Journal of the American Medical Association.
N. Jewel Samadder, M.D., from the University of Utah in Salt Lake City, and colleagues examined the effect of the combination of sulindac and erlotinib on duodenal adenoma regression in 92 patients with FAP. Participants were randomized to sulindac twice daily and erlotinib daily (46 patients) or placebo (46 patients) for six months.
The second preplanned interim analysis met the prespecified stopping rule for superiority, and consequently the trial was stopped by the external data and safety monitoring board. The researchers found that the sulindac-erlotinib group had significant reductions in the median duodenal polyp burden (sum of the diameters of polyps) and polyp count (both P < 0.001). The sulindac-erlotinib group more often had grade 1 and 2 adverse events, with an acne-like rash seen in 87 and 20 percent of patients receiving treatment and placebo, respectively (P < 0.01). Two patients experienced grade 3 adverse events.
"Further research is necessary to evaluate these preliminary findings in a larger study population with longer follow-up to determine whether the observed effects will result in improved clinical outcomes," the authors write.
Several authors disclosed financial ties to the biopharmaceutical industry.