In the single-arm, multicenter study, 46 adults with FAP self-administered 350 mg of erlotinib by mouth one time per week for 6 months. All but four participants completed the 6-month study.
After 6 months of weekly erlotinib, duodenal polyp burden was significantly reduced, with a mean percent reduction of 29.6% ."Though only 12% of patients noted a decrease in Spigelman stage from 3 to 2 associated with therapy, the majority of patients had stable disease while on treatment," the study team reports.While once-weekly erlotinib was"generally" well tolerated, grade 2 or 3 AEs were reported in 72% of patients; two suffered grade 3 toxicity.
Four patients withdrew from the study because of drug-induced AEs, which included grade 3 rash acneiform, grade 2 infections , grade 1 fatigue, and grade 1 rash acneiform. No grade 4 AEs were reported. The most common AE was an erlotinib-induced acneiform-like rash, which occurred in 56.5% of study patients. The rash was managed with topical