HER-2/neu gene amplification characterized by fluorescence in situ hybridization: poor prognosis in node-negative breast carcinomas.

Abstract

FISH was an alternative technique for determining gene amplification and had some distinct advantages over Southern hybridization. Our results demonstrate that HER-2/neu gene amplification in the absence of adjuvant therapy is an independent predictor of poor clinical outcome and is a stronger discriminant than tumor size. Women with small tumors that had gene amplification were at increased risk of recurrence and disease-related death.

Analysis of HER-2/neu amplification in endometrial carcinoma by chromogenic in situ hybridization. Correlation with fluorescence in situ hybridization, HER-2/neu, p53 and Ki-67 protein expression, and outcome

“…2,8 Several methods have been proved to be useful for the assessment of HER-2/ neu status. 4,5,7,[10][11][12][13] Nevertheless, considerable confusion exists with regard to the appropriate method and reagent for testing it in routine clinical practice. 7 Furthermore, most of the methods are beyond the scope of the majority of pathology laboratories due to technical, practical, and economical reasons.…”

“…[2][3][4][5][6] Moreover, HER-2/neu has become of special interest due to the reported association with patients' outcome and the potential role for treatment. 3,4,7,8 The development of a novel therapeutic agent (Herceptin) that directly targets the protein has increased the demand for testing HER-2/neu status. 2,9 Several techniques have been used to detect HER-2/neu abnormalities.…”

“…Gene copy number can be evaluated by FISH, PCR, dot-blot hybridization, or Southern blot. 5,7,[10][11][12][13] However, the majority of these methods are recommended as complementary to assess gene status in doubtful cases by immunohistochemistry, and they are only available in some laboratories. 11,[13][14][15] Thus, there is currently a need of new methods for routine clinical practice.…”

Strong Correlation between Results of Fluorescent In Situ Hybridization and Immunohistochemistry for the Assessment of the ERBB2 (HER-2/neu) Gene Status in Breast Carcinoma

“…More than 10 years after the first report by Slamon et al (1) showing the existence of a correlation between ERBB2 amplification and poor prognosis in breast carcinoma, the role of ERBB2 amplification/overexpression as an independent prognostic marker remains controversial, especially in node negative cases (3,5,8,15,16; for review, see 6, 7). Similarly, its predictive value regarding tumor response to treatment is still unclear (9 -14; for review, see 6, 7).…”

“…Indeed, results of molecular methods may be affected by the dilution of tumor material by normal cells and by the determination of the threshold defining the existence of an amplification or an overexpression (2,7,21). Recent technical developments have made possible the detection of the ERBB2 gene in tissue sections, touch preparations, and fine-needle aspirates using fluorescent in situ hybridization (FISH) (16,(22)(23)(24)(25)(26)(27)(28)(29)(30)(31)(32). The most reliable method to routinely evaluate the status of ERBB2 in prospective and archival material remains to be determined.…”