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Bending the Curve Trial by Trial
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Helicobacter pylori Therapy for the Prevention of Metachronous Gastric Cancer

N = 470NCT02407119

Population
Patients who had undergone endoscopic resection of early gastric cancer or high-grade adenoma.
Design
Prospective, double-blind, placebo-controlled randomised trial of 470 patients who had undergone endoscopic resection of early gastric cancer or high-grade adenoma: H. pylori eradication therapy or placebo. Two primary outcomes: metachronous gastric cancer detected at 1-year follow-up or later, and improvement in the grade of gastric corpus (lesser curvature) atrophy at 3 years. The modified ITT population was 396 (194 treatment, 202 placebo). The ClinicalTrials.gov enrolment of 470 matches the abstract.
Primary endpoint
Metachronous gastric cancer, Improvement in gastric corpus atrophy grade
Arms
  • Placebo (control): Placebo
  • H. pylori eradication therapy (experimental): Antibiotic-based H. pylori eradication therapy
People
Choi IJ, senior author Nam BH
Metachronous gastric cancerHR 0.50 (95% CI 0.26–0.94)Δ Metachronous gastric cancer−6.2 pointsΔ Improvement in gastric corpus atrophy grade+33.4 points
Show the numbers
Results reported for Helicobacter pylori Therapy for the Prevention of Metachronous Gastric Cancer
EndpointAnalysisH. pylori eradication therapyPlaceboEffect
Metachronous gastric cancerModified ITT: 396 patients (194 treatment, 202 placebo)primarymedian follow-up 5.9 yearsChoi 20187.2%13.4%HR 0.50 (95% CI 0.26–0.94)P=0.03Rates are cumulative proportions with cancer as published, without a stated time point.
Improvement in gastric corpus atrophy gradeSubgroup that underwent histologic analysis (n = 327)primaryChoi 201848.4%15%P<0.001Assessed at the 3-year follow-up in the histologic subgroup.
Results reported for Helicobacter pylori Therapy for the Prevention of Metachronous Gastric Cancer
EndpointAnalysisH. pylori eradication therapyPlaceboEffect
Metachronous gastric cancerModified ITT: 396 patients (194 treatment, 202 placebo)primarymedian follow-up 5.9 yearsChoi 20187.2%13.4%HR 0.50 (95% CI 0.26–0.94)P=0.03Rates are cumulative proportions with cancer as published, without a stated time point.
Improvement in gastric corpus atrophy gradeSubgroup that underwent histologic analysis (n = 327)primaryChoi 201848.4%15%P<0.001Assessed at the 3-year follow-up in the histologic subgroup.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
Metachronous gastric cancer0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
Metachronous gastric cancer0.50.26–0.94
Primary publication: Choi IJ, Kook MC, Kim YI, Cho SJ, Lee JY, Kim CG, et al. Helicobacter pylori Therapy for the Prevention of Metachronous Gastric Cancer. N Engl J Med. 2018;378(12):1085-1095. PubMedDOI

Appears in

Sources

  1. Choi IJ, Kook MC, Kim YI, Cho SJ, Lee JY, Kim CG, et al. Helicobacter pylori Therapy for the Prevention of Metachronous Gastric Cancer. N Engl J Med. 2018;378(12):1085-1095.

    PubMedDOI