Antibiotic Therapy for Helicobacter pylori Infection and Prevention of Metachronous Gastric Cancer
In a Korean study reported in The New England Journal of Medicine, Choi et al found that antibiotic treatment for Helicobacter pylori was associated with a significant reduction in metachronous gastric cancer in patients who had undergone endoscopic resection of early gastric cancer or high-grade adenoma.
Study Details
In the double-blind trial conducted at the South Korea National Cancer Center, 470 patients with H pylori infection who were scheduled for endoscopic resection of histologically differentiated early gastric cancer or high-grade adenoma were randomized to receive antibiotic eradication therapy with amoxicillin (1,000 mg), clarithromycin (500 mg), and the proton-pump inhibitor rabeprazole (10 mg) twice daily for 7 days (n = 236) or placebo and rabeprazole (n = 234), with both groups receiving rabeprazole for an additional 4 weeks for ulcer healing. Randomization was stratified by severity of grade of histologic atrophy at the antrum. Of the 470 patients, 396 were included in the modified intent-to-treat population (194 in the antibiotic group, 202 in placebo group); 74 patients were excluded for additional surgery after endoscopic resection, not receiving trial medication, or failing to meet other eligibility requirements.
Two primary outcomes were the incidence of metachronous gastric cancer at 1-year follow-up or thereafter in the modified intent-to-treat population, and improvement in grade of glandular atrophy in the gastric corpus lesser curvature at 3-year follow-up.
Prevention of Metachronous Disease
Median follow-up was 5.9 years. Metachronous gastric cancer developed in 14 patients (7.2%) in the antibiotic treatment group and in 27 patients (13.4%) in the placebo group (hazard ratio = 0.50, P = .03). Among 162 patients in the antibiotic treatment group and 167 in the placebo group who underwent histologic analysis, improvement from baseline in atrophy grade at the gastric corpus lesser curvature was observed at 3 years in 48.4% vs 15.0% (P < .001). Improved grade of intestinal metaplasia at the same site was observed in 36.6% vs 18.3% (P < .001).
Adverse Events
Mild drug-related adverse events, including taste alteration, diarrhea, and dizziness, were more common in the antibiotic treatment group (42.0% vs 10.2%, P < .001). No serious adverse events were reported. No significant difference between groups was observed in proportion of patients receiving medication to treat gastrointestinal symptoms during follow-up.
The investigators concluded, “Patients with early gastric cancer who received H. pylori treatment had lower rates of metachronous gastric cancer and more improvement from baseline in the grade of gastric corpus atrophy than patients who received placebo.”
The study was funded by the National Cancer Center, South Korea.
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