Helicobacter pylori and gastric cancer:current status of the Austrain Czech German gastric cancer prevention trial (PRISMA Study).
OBJECTIVE
To test the hypothesis that Helicobacter pylori eradication alone can reduce the incidence of gastric cancer in a subgroup of individuals with an increased risk for this fatal disease.


METHODS
It is a prospective, randomized, double blind, placebo controlled multinational multicenter trial. Men between 55 and 65 years of age with a gastric cancer phenotype of Helicobacter pylori gastritis are randomized to receive a 7 day course of omeprazole 2 X 20mg, clarithromycin 2 X 500mg, and amoxicillin 2 X 1g for 7 days, or omeprazole 2 X 20mg plus placebo. Follow-up endoscopy is scheduled 3 months after therapy, and thereafter in one-year intervals. Predefined study endpoints are gastric cancer, precancerous lesions (dysplasia, adenoma), other cancers, and death.


RESULTS
Since March 1998, 1524 target patients have been screened, 279 patients (18.3%) had a corpus dominant type of H. pylori gastritis, and 167 of those were randomized (58.8%). In the active treatment group (r = 86), H. pylori infection infection was cured in 88.9% of patients. Currently, the cumulative follow-up time is 3046 months (253.38 patient years, median follow up 16 months). So far, none of the patients developed gastric cancer or any precancerous lesion. Three (1.8%) patients reached study endpoints other than gastric cancer.


CONCLUSIONS
Among men between 55 and 65 years of age, the gastric cancer phenotype of H. pylori gastritis appears to be more common than expected. Further follow up and continuing recruitment are necessary to fulfil the main aim of the study.
Miehlke
S
S
Medical Department I, Technical University Hospital Carl Gustav Carus, Fetscherstrabetae 74, D 01307 Dresden, Germany.
Kirsch
C
C
Dragosics
B
B
Gschwantler
M
M
Oberhuber
G
G
Antos
D
D
Dite
P
P
Läuter
J
J
Labenz
J
J
Leodolter
A
A
Malfertheiner
P
P
Neubauer
A
A
Ehninger
G
G
Stolte
M
M
Bayerdörffer
E
E
D000658:Amoxicillin / Q000627:therapeutic use*; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D017291:Clarithromycin / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005756:Gastritis / Q000188:drug therapy* / Q000382:microbiology; D005765:Gastrointestinal Agents / Q000627:therapeutic use*; D016481:Helicobacter Infections / Q000188:drug therapy*; D016480:Helicobacter pylori; D006801:Humans; D008297:Male; D008875:Middle Aged; D009853:Omeprazole / Q000627:therapeutic use*; D011446:Prospective Studies; D013274:Stomach Neoplasms / Q000382:microbiology* / Q000517:prevention & control*
D000900:Anti-Bacterial Agents; D005765:Gastrointestinal Agents; D000658:Amoxicillin; D017291:Clarithromycin; D009853:Omeprazole