Effect of Sulindac and Erlotinib vs Placebo on Duodenal Neoplasia in Familial Adenomatous Polyposis: A Randomized Clinical Trial.

ABSTRACT:

Importance

Patients with familial adenomatous polyposis (FAP) are at markedly increased risk for duodenal polyps and cancer. Surgical and endoscopic management of duodenal neoplasia is difficult and chemoprevention has not been successful.

Objective

To evaluate the effect of a combination of sulindac and erlotinib on duodenal adenoma regression in patients with FAP.

Design, setting, and participants

Double-blind, randomized, placebo-controlled trial, enrolling 92 participants with FAP, conducted from July 2010 through June 2014 at Huntsman Cancer Institute in Salt Lake City, Utah.

Interventions

Participants with FAP were randomized to sulindac (150 mg) twice daily and erlotinib (75 mg) daily (n = 46) vs placebo (n = 46) for 6 months.

Main outcomes and measur

SUBMITTER: Samadder NJ 

PROVIDER: S-EPMC5003411 | biostudies-literature | 2016 Mar 22-29

REPOSITORIES: biostudies-literature