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Bending the Curve Trial by Trial
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Family History of Gastric Cancer and Helicobacter pylori Treatment

N = 1,838NCT01678027

Population
First-degree relatives of patients with gastric cancer who had H. pylori infection.
Design
Single-centre, double-blind, placebo-controlled trial: 3100 first-degree relatives of patients with gastric cancer were screened and 1838 with H. pylori infection were randomised to eradication therapy (lansoprazole 30 mg, amoxicillin 1000 mg, clarithromycin 500 mg, each twice daily for 7 days) or placebo. Primary outcome: development of gastric cancer. The modified ITT population was 1676 (832 treatment, 844 placebo). The ClinicalTrials.gov enrolment of 1838 matches the abstract.
Primary endpoint
Gastric cancer incidence
Arms
  • Placebo (control): Placebo
  • H. pylori eradication (experimental): Lansoprazole 30 mg, amoxicillin 1000 mg and clarithromycin 500 mg, each twice daily for 7 days
People
Choi IJ, senior author Joo J
Gastric cancer incidenceHR 0.45 (95% CI 0.21–0.94)Δ Gastric cancer incidence−1.5 points
Show the numbers
Results reported for Family History of Gastric Cancer and Helicobacter pylori Treatment
EndpointAnalysisH. pylori eradicationPlaceboEffect
Gastric cancer incidenceModified ITT: 1676 participants (832 treatment, 844 placebo)primarymedian follow-up 9.2 yearsChoi 20201.2%2.7%HR 0.45 (95% CI 0.21–0.94)P=0.03A prespecified secondary comparison by eradication status (not a randomised comparison): gastric cancer in 0.8% (5 of 608) of participants with eradicated infection and 2.9% (28 of 979) with persistent infection, HR 0.27 (95% CI 0.10 to 0.70).
Results reported for Family History of Gastric Cancer and Helicobacter pylori Treatment
EndpointAnalysisH. pylori eradicationPlaceboEffect
Gastric cancer incidenceModified ITT: 1676 participants (832 treatment, 844 placebo)primarymedian follow-up 9.2 yearsChoi 20201.2%2.7%HR 0.45 (95% CI 0.21–0.94)P=0.03A prespecified secondary comparison by eradication status (not a randomised comparison): gastric cancer in 0.8% (5 of 608) of participants with eradicated infection and 2.9% (28 of 979) with persistent infection, HR 0.27 (95% CI 0.10 to 0.70).
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
Gastric cancer incidence0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
Gastric cancer incidence0.450.21–0.94
Primary publication: Choi IJ, Kim CG, Lee JY, Kim YI, Kook MC, Park B, et al. Family History of Gastric Cancer and Helicobacter pylori Treatment. N Engl J Med. 2020;382(5):427-436. PubMedDOI

Appears in

Sources

  1. Choi IJ, Kim CG, Lee JY, Kim YI, Kook MC, Park B, et al. Family History of Gastric Cancer and Helicobacter pylori Treatment. N Engl J Med. 2020;382(5):427-436.

    PubMedDOI