Safety and Efficacy of Eflornithine in Patients with Gastric Precancerous Lesions: A Double-Blinded, Randomized Clinical Trial
Abstract
Gastric adenocarcinoma is the fifth leading cause of global cancer mortality and a major health disparity in the United States. Effective chemoprevention strategies are limited for high-risk individuals with gastric premalignant conditions (GPMC). We conducted an NCI Division of Cancer Prevention-funded, double-blinded, phase IIa randomized, placebo-controlled trial evaluating eflornithine for chemoprevention in GPMC (NCT02794428). The study was executed in rural Honduras and Puerto Rico, regions with a high prevalence of Helicobacter pylori and gastric intestinal metaplasia (GIM), from September 2016 to December 2022. Eligible subjects (ages 30-69; H. pylori-positive or H. pylori-negative) were randomized 1:1 to receive 500 mg/day eflornithine or placebo for 18 months. Upper endoscopy was performed at baseline, 6, 18, and 24 months. H. pylori-positive patients were offered antibiotic treatment at 6 months. A total of 211 patients were screened, and 91 were randomized (45 to eflornithine and 46 to placebo). The mean age was 45.2 years (SD 8.8), and 74% were female. At baseline, 46% and 54% had gastric atrophy and GIM, respectively. Eighty percent were H. pylori-positive. Follow-up completion rates were 78 patients (6 months), 69 patients (18 months), and 55 patients (24 months). Eflornithine was well tolerated, with fewer grade 1 to 2 adverse events in the eflornithine group (81 vs. 108, placebo). No significant histology score differences were observed. A significant…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 211 participants or records.
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