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While cigarette smoking is a well-established risk factor for pancreatic cancer, the role of alcohol, coffee, and tea consumption remains controversial. In view of this, and because of the limited information on possible environmental risk factors of pancreatic cancer in Italy, we carried out this study. Five hundred seventy patients with newly diagnosed pancreatic cancer and 570 controls from 14 Italian centers were studied. Using a standardized questionnaire, all were interviewed personally about their smoking habits, as well as habitual alcohol, coffee, and tea consumption throughout their lives prior to clinical onset of the disease. Details were also obtained on exposure to potential occupational carcinogens. A moderate association, statistically significant only in women (odds ratio, 2.18; 95% confidence interval, 1.30-3.68), was found between pancreatic cancer and cigarette smoking, but none was observed with alcohol or tea consumption or with any particular occupational exposure. Consumption of 1 or 2 cups of coffee per day was not associated with increased risk; 3 coffees per day increased the risk, but not significantly (odds ratio, 1.49; 95% confidence interval, 0.97-2.30); with consumption of more than 3 coffees per day the increase in risk was highly significant (odds ratio, 2.53; 95% confidence interval, 1.53-4.18). A statistically significant dose-response relationship (p < 0.001) was observed in each sex. The association between coffee use and pancreatic cancer still held after controlling for potential confounding factors such as cigarette smoking or alcohol use, and when the analysis was restricted to nonsmoking coffee drinkers. The results of this study, one of the largest of its type so far published, suggest that a causal relationship may exist between coffee consumption and pancreatic cancer.