HEL. PYLORI TREATMENT FOR RELATIVES OF PATIENTS WITH GASTRIC CANCER

In a large Korean single-center study reported in The New England Journal of Medicine, Choi et al found that eradication of Helicobacter pylori infection was associated with a reduced risk of gastric cancer in individuals with a family history of gastric cancer in first-degree relatives.As stated by the investigators, H pylori infection and family history of gastric cancer are the main risk factors for gastric cancer.

Study Details

In the double-blind trial, performed at the National Cancer Center in Goyang, South Korea, 3,100 first-degree relatives of patients with gastric cancer were screened for H pylori infection between November 2004 and December 2011. A total of 1,676 participants with H pylori infection (modified intention-to-treat population) were randomly assigned to receive eradication therapy (n = 832) or placebo (n = 834).

Eradication therapy consisted of lansoprazole at 30 mg, amoxicillin at 1,000 mg, and clarithromycin at 500 mg each taken twice daily for 7 days. Surveillance endoscopies were performed every 2 years. The primary outcome measure was development of gastric cancer.

Key Findings

Median follow-up was 9.2 years. Gastric cancer developed in 10 participants (1.2%) in the treatment group vs 23 (2.7%) in the placebo group (hazard ratio [HR] = 0.45, 95% confidence interval [CI] = 0.21–0.94, P = .03).

Among the 10 participants in the treatment group who developed gastric cancer, 5 (50.0%) had persistent H pylori infection.

The number needed to treat to prevent one case of gastric cancer was 65.7 over the duration of the trial.

H pylori eradication status was evaluated in 1,587 participants during follow-up, with eradication being confirmed in 551 (70.1%) of 786 participants in the treatment group and in 57 (7.1%) of 801 in the placebo group. H pylori infection persisted in the remaining 979 participants. Overall, gastric cancer developed in 5 (0.8%) of the 608 participants with eradication and in 28 (2.9%) of the 979 with persistent infection (HR = 0.27, 95% CI = 0.10–0.70).

Adverse events were mild, with those of any grade being more common in the treatment group (53.0% vs 19.1%, P < .001). Grade ≥ 3 adverse events occurred in seven patients (0.8%) in the treatment group. The most common adverse events of any grade in the treatment group included taste alteration (32% of patients in the treatment group, vs 4% of patients treated with placebo), diarrhea (22% vs 6%), nausea (7% vs 3%), and abdominal pain (5% vs 1%).

The investigators concluded: “Among persons with H pylori infection who had a family history of gastric cancer in first-degree relatives, H pylori eradication treatment reduced the risk of gastric cancer.”

Disclosure: The study was funded by the National Cancer Center, South Korea. For full disclosures of the study authors, visit nejm.org.