Prognostic significance of HER‐2/neu gene amplification status by fluorescence in Situ hybridization of prostate carcinoma

BACKGROUND HER‐2/neu gene amplification, established as a prognostic factor in breast carcinoma and other cancers, has not been correlated with outcome in prostate carcinomas (PCs). METHODS HER‐2/neu gene amplification was determined by automated fluorescence in situ hybridization (FISH) using a unique sequence cosmid probe on 113 formalin fixed, paraffin embedded 4‐μm tissue sections and the results compared with tumor grade, DNA ploidy, HER‐2/neu protein expression by immunohistochemistry (IHC), serum prostate specific antigen, pathologic stage, and postoperative disease recurrence (mean follow‐up of 44 months). RESULTS HER‐2/neu gene amplification by FISH (41% of PCs) correlated with tumor grade (P = 0.001) and DNA ploidy status (P = 0.0003). HER‐2/neu protein overexpression by IHC (29% of PCs) correlated with grade (P = 0.03), but not with DNA ploidy. A trend for similar HER‐2/neu status in each PC by IHC and FISH did not reach statistical significance (P = 0.25). On univariate analysis, HER‐2/neu amplification by FISH (P = 0.029), tumor grade (P = 0.013), and DNA ploidy (P = 0.016) correlated with postoperative disease recurrence. HER‐2/neu expression by IHC did not correlate with outcome. On multivariate analysis, grade (P = 0.0001) and ploidy (P = 0.001) were independent outcome predictors; HER‐2/neu amplification by FISH reached near‐independent significance (P = 0.125). CONCLUSIONS HER‐2/neu gene amplification by FISH on archival PCs significantly correlates with grade and DNA ploidy status, is more sensitive than IHC in detecting HER‐2/neu gene abnormalities, predicts postoperative disease recurrence, and may prove important in planning therapy for patients with prostate carcinoma. Cancer 1997; 79:2162‐70. © 1997 American Cancer Society. HER‐2/neu gene amplification by fluorescence in situ hybridization correlates with tumor grade and DNA ploidy and predicts disease recurrence in surgically treated prostate carcinoma patients.