This study was performed to determine the frequency of expression loss of p 16 and pRb; their relations with each other, tumour histology, tumour stage, nodal status, and,survival in formalin fixed, paraffin embedded tumour tissues of patients with non-small-cell lung carcinoma (NSCLC). P16 and/or pRb expression loss is observed in 72 (75.8%) out of 95 patients, and 70 (73.7%) of them showed inverse correlation (P < 0.05). Thirty-six (37.9%) of the p16 positive cases usually showed weak or moderate immunohistochemical staining. Loss of p16 expression was found to be significantly greater in squamous cell carcinoma than in adenocarcinoma cases, whilst no relation was observed with other clinical parameters. Immunohistochemical reactivity for pRb was generally moderate or strong. PRb expression loss was observed in 15.8% of the cases, and no relation was found between pRb loss and age, sex, tumour histology, tumour stage, or nodal status. PRb negative squamous cell carcinoma cases had significantly shorter survival independent of nodal status. These results suggest that disruption of p16/pRb pathway is frequently involved in NSCLC, and pRb expression loss in cases with squamous cell carcinoma may predict clinical outcome. (C) 2002 Elsevier Science Ireland Ltd. All rights reserved.