Family History of Gastric Cancer and Helicobacter pylori Treatment
- Study type
- Clinical trial
- Study name
- Choi 2020 (H. pylori – family history)
- Phase
- Phase 3
- Design
- Randomised, double-blind, placebo-controlled, single-centre trial (National Cancer Center, South Korea)
- Sample size
- 1838 participants randomised; 1676 in the modified intention-to-treat population
- Source
- N Engl J Med · 2020
- Trial registration
- NCT01678027
In plain words
If your father, mother, sister or brother has had stomach cancer, your risk is higher, and infection with the germ Helicobacter pylori also raises this risk. In this Korean study, first-degree relatives of patients with stomach cancer who had this germ received one week of three-drug treatment or a placebo. Over about 9 years of follow-up, stomach cancer in the treated group fell to less than half (1.2% versus 2.7%), and the drop in risk was greater in those in whom the germ was actually cleared. The side effects of the drugs were mild. If you have a family history of stomach cancer, talk to your doctor about testing and treatment for Helicobacter.
Key results
Treatment arms and regimens
Lansoprazole 30 mg, amoxicillin 1000 mg and clarithromycin 500 mg, each twice daily for 7 days (orally).
Placebos matching lansoprazole, amoxicillin and clarithromycin, twice daily for 1 week.
Source of the regimen details: Abstract of the paper (NEJM 2020) and ClinicalTrials.gov NCT01678027 (lansoprazole 30, amoxicillin 1000 and clarithromycin 500 mg twice daily for 7 days)
Doses are given for the information of specialists, as in this study’s protocol, and are not a prescription. Every drug must be prescribed by the treating physician for the individual patient.
Study population
First-degree relatives (siblings or children) of patients with stomach cancer who were infected with Helicobacter pylori. 3100 people were screened. People with a history of stomach cancer, peptic ulcer, prior Helicobacter eradication treatment, hereditary cancer syndromes (HNPCC, FAP) or serious comorbidities were not enrolled.
Endpoints
Primary endpoint: incidence of gastric cancer.
Prespecified secondary endpoint: incidence of gastric cancer according to Helicobacter pylori eradication status during follow-up.
Safety and side effects
Adverse events were mild and occurred more often in the treatment group than in the placebo group (53.0% versus 19.1%; P<0.001).
Clinical significance and place in guidelines
This randomised double-blind trial showed that eradicating Helicobacter pylori in first-degree relatives of patients with gastric cancer reduces the incidence of gastric cancer, and it supports testing and treating Helicobacter in people with a family history. The NCCN guideline (version 2.2025) recommends screening for a family history of gastric cancer and considers Helicobacter pylori testing/screening and genetic testing where needed; it also recommends Helicobacter testing and eradication (if positive) in all patients with early gastric cancer.
Limitations
The study was single-centre and conducted in South Korea (a country with a high incidence of gastric cancer), and its generalisability to low-risk regions is unknown. The total number of gastric cancer cases was small (33 cases), and the clarithromycin-based triple regimen may be less effective in regions with high antimicrobial resistance; half of the cancers in the treatment group occurred in people whose infection had not been eradicated. People with hereditary cancer syndromes were not enrolled.
This summary was prepared by the editorial team from the published paper; the original paper is the final reference. Read the original abstract on PubMed.