Association of Sulindac and Erlotinib vs Placebo With Colorectal Neoplasia in Familial Adenomatous Polyposis: Secondary Analysis of a Randomized Clinical Trial.

ABSTRACT:

Importance

Patients with familial adenomatous polyposis (FAP) are at markedly increased risk for colorectal polyps and cancer. A combination of sulindac and erlotinib led to a 71% reduction in duodenal polyp burden in a phase 2 trial.

Objective

To evaluate effect of sulindac and erlotinib on colorectal adenoma regression in patients with FAP.

Design, setting, and participants

Prespecified secondary analysis for colorectal adenoma regression was carried out using data from a double-blind, randomized, placebo-controlled trial, enrolling 92 patients with FAP, conducted from July 2010 to June 2014 in Salt Lake City, Utah.

Interventions

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

SUBMITTER: Samadder NJ 

PROVIDER: S-EPMC5885170 | biostudies-literature | 2018 May

REPOSITORIES: biostudies-literature