In a study appearing in the March 22/29 issue of JAMA, Deborah W. Neklason, Ph.D., N. Jewel Samadder, M.D., M.S., of the Huntsman Cancer Institute, University of Utah, Salt Lake City, and colleagues randomly assigned 92 patients with familial adenomatous polyposis to the drugs sulindac twice daily and erlotinib daily (n = 46) or placebo (n = 46) for 6 months.
Familial adenomatous polyposis (FAP) is an inherited disorder, and patients with FAP are at markedly increased risk for duodenal (part of the small intestine) polyps and cancer. Surgical and endoscopic management of duodenal neoplasia is difficult and chemoprevention has not been successful.
The researchers found that sulindac in combination with erlotinib effectively reduced the total duodenal polyp burden and polyp number in participants with FAP compared with placebo. This effect was significant after 6 months of therapy.
Grade 1 and 2 adverse events were more common in the sulindac-erlotinib group, with an acne-like rash observed in 87 percent of participants receiving treatment and 20 percent of participants receiving placebo. “Adverse events may limit the use of these medications at the doses used in this study,” the authors write.
“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.”
- N. Jewel Samadder, Deborah W. Neklason, Kenneth M. Boucher, Kathryn R. Byrne, Priyanka Kanth, Wade Samowitz, David Jones, Sean V. Tavtigian, Michelle W. Done, Therese Berry, Kory Jasperson, Lisa Pappas, Laurel Smith, Danielle Sample, Rian Davis, Matthew K. Topham, Patrick Lynch, Elena Strait, Wendy McKinnon, Randall W. Burt, Scott K. Kuwada. Effect of Sulindac and Erlotinib vs Placebo on Duodenal Neoplasia in Familial Adenomatous Polyposis. JAMA, 2016; 315 (12): 1266 DOI: 10.1001/jama.2016.2522
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