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TOPLINE:
Adding Helicobacter pylori stool antigen (HPSA) testing to a fecal immunochemical test (FIT)–based colon cancer screening program did not reduce gastric cancer incidence or mortality compared with FIT alone. However, after adjusting for confounders, the incidence of gastric cancer was lower in the HPSA testing plus FIT group.
METHODOLOGY:
Gastric cancer is a leading cause of cancer death globally, with chronic H pylori infections responsible for at least 80% of cases. This community-based clinical trial aimed to evaluate the effects of adding HPSA testing to a FIT-based colon cancer screening program on the incidence and mortality of gastric cancer.
Researchers randomly assigned in a 1:1 ratio 240,000 individuals (mean age, 58.1 years; 46.8% women), who were eligible for their biennial colon cancer screening, to receive an invitation via phone calls for either HPSA testing plus FIT or FIT alone.
After exclusions for people who didn’t receive their invitation or were unreachable, 63,508 were invited to get HPSA testing plus FIT and 88,995 to get FIT alone.
HPSA testing was only available in the HPSA test + FIT group, and participants who tested positive received treatment with antibiotics for H pylori eradication.
The primary outcomes were the incidence and mortality rates of gastric cancer. The median follow-up duration was 5.7 years and 5.4 years for the HPSA testing plus FIT group and FIT-alone group, respectively.
TAKEAWAY:
The screening participation rates were higher for the HPSA testing plus FIT group (49.6%) than for the FIT-alone group (35.7%).
Among the 12,142 participants with positive HPSA test results, 71.4% received antibiotic therapy, and 91.9% achieved eradication of H pylori after one or two courses of antibiotic treatment.
Among all invited participants, there was no statistically significant difference in the incidence rates of gastric cancer between the HPSA testing plus FIT group and the FIT-alone group (0.032% vs 0.037%). The mortality rates of gastric cancer were also not significantly different between the two groups (0.015% vs 0.013%).
After adjusting for differences in screening participation rates, length of follow-up, and baseline characteristics of the participants, the incidence rate of gastric cancer was significantly lower for the group invited to get an HPSA test plus FIT (relative risk, 0.79; P = .04) than for the group invited to get FIT alone. No significant difference in gastric cancer mortality was observed after adjustments.
IN PRACTICE:
“This innovative trial conveys valuable insights for the primary prevention of gastric cancer, with potential application to diverse settings. Notably, the results show that implementation of H pylori test-and-treat strategies is indeed possible using screening platforms already in place,” M. Constanza Camargo, PhD, MSc, MHA, Division of Cancer Epidemiology and Prevention, National Cancer Institute, Rockville, Maryland, wrote in an accompanying editorial.
SOURCE:
The study, led by Yi-Chia Lee, MD, PhD, Department of Internal Medicine, College of Medicine, National Taiwan University, Taipei City, Taiwan, was published online in JAMA.
LIMITATIONS:
The study had several limitations, including a high number of unreachable participants, which may have affected the validity of the results. Only 41.5% of invited participants underwent tests, and among those with a positive result for HPSA testing, only 71.4% received treatment. Differences in baseline characteristics between the two randomized groups and differences in the length of follow-up may have compromised the validity of the results. The relatively short follow-up periods may have reduced the ability to identify differences in the rates of outcomes.
DISCLOSURES:
This study received grants from the Taiwan Health Promotion Administration of the Ministry of Health and Welfare and the National Taiwan University Hospital. The authors declared having no conflicts of interest.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
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