Phase II trial of weekly erlotinib dosing to reduce duodenal polyp burden associated with familial adenomatous polyposis.

ABSTRACT:

Importance

Patients with familial adenomatous polyposis (FAP) are at markedly increased risk for duodenal adenomas and cancer. Combination sulindac and erlotinib was previously shown to reduce duodenal polyp burden but was associated with a relatively high adverse event (AE) rate.

Objective

To evaluate if a once weekly dosing schedule for erlotinib intervention improves the AE profile, while still providing efficacy with respect to reduced polyp burden, in participants with FAP.

Design, setting and participants

Single-arm trial, enrolling 46 participants with FAP, conducted from October 2017 to September 2019 in eight academic cancer centres.

Exposures

Participants self-administered 350 mg of erlotinib by mouth, one time per week for 6 months.

Main outcomes

SUBMITTER: Samadder NJ 

PROVIDER: S-EPMC9708943 | biostudies-literature | 2023 Feb

REPOSITORIES: biostudies-literature