c-erbB2 gene amplification or over-expression has been reported in ovarian cancer, but their prognostic value remains conflicting. To investigate the respective prognostic significance of c-erbB2 gene amplification and protein over-expression, tumor samples were obtained from 65 patients with ovarian adenocarcinoma (9 FIGO stage I, 7 stage II, 38 stage III and II stage IV) followed up for a median period of 71 months. c-erbB2 gene amplification (> or = 2.5 a.u.) was detected in 9/65 (14%) adenocarcinomas and in none of 5 benign and 8 borderline ovarian epithelial tumors also analyzed. Specimens from 52 of the 65 adenocarcinomas were available for immunohistochemical analysis. c-erbB2 protein expression was observed in 23/52 (44%) adenocarcinomas. No correlation was found between c-erbB2 gene copy number and protein expression. There was no correlation of c-erbB2 gene copy number or protein expression with any of the clinico-pathological factors analyzed (i.e., FIGO stage, histological type, histological grade and residual tumor). On univariate analysis, c-erbB2 gene amplification was associated with poorer survival (p = 0.04). However, in the multivariate analysis of clinico-pathological factors and c-erbB2 gene copy number, c-erbB2 gene amplification did not retain any independent prognostic significance (p = 0.19). No significant survival difference was found between patients with and without c-erbB2 protein over-expression in univariate or multivariate analyses. Therefore, neither c-erbB2 gene amplification nor c-erbB2 protein over-expression appears to be a significant prognostic marker in patients with ovarian carcinoma.