We have reported frequent allele loss for the marker HRAS on chromosome 11p in human lung cancer and defined the smallest common region of deletion (designated LOH11B) to approximately 500 kb. Here, we investigated the association of allele loss for LOH11B with epidemiological, pathological, and clinical parameters. Analysis of allele loss was performed using Southern blotting on a cohort of 200 patients with lung cancer, and data were interpreted with the use of a phosphorimager. Results were statistically compared with retrospectively collected variables. LOH11B allele loss was significantly associated with cigarette consumption (P = 0.009), gender (P = 0.02), and survival (P = 0.04). None of the nonsmokers had allele loss as compared with 28% of the patients with low and 43% with high cigarette consumption. Allele loss was more frequent in men (43%) than in women (11%). The median survival of patients without allele loss was 42 months compared with 25 months for patients with allele loss. These results suggest that the LOH11B region contains a gene responsible for a more malignant phenotype independent of the metastatic potential of lung cancer. They also suggest that alterations in this gene are associated with cigarette consumption and are more frequent in men than in women.