HER-2/neu Evaluation by Fluorescence in Situ Hybridization on Destained Cytologic Smears from Primary and Metastatic Breast Cancer

2005 ◽  
Vol 49 (1) ◽  
pp. 27-30 ◽  
Author(s):  
Rita Nizzoli ◽  
Annamaria Guazzi ◽  
Nadia Naldi ◽  
Vittorio Franciosi ◽  
Cecilia Bozzetti
Keyword(s):  
Breast Cancer ◽  
In Situ Hybridization ◽  
Metastatic Breast Cancer ◽  
Fluorescence In Situ Hybridization ◽  
Metastatic Breast ◽  
Her 2

scholarly journals Evaluation of the Quantitative Analytical Methods Real-Time PCR for HER-2 Gene Quantification and ELISA of Serum HER-2 Protein and Comparison with Fluorescence in Situ Hybridization and Immunohistochemistry for Determining HER-2 Status in Breast Cancer Patients

2005 ◽  
Vol 51 (7) ◽  
pp. 1093-1101 ◽  
Author(s):  
Chantal Tse ◽  
Didier Brault ◽  
Joseph Gligorov ◽  
Martine Antoine ◽  
Rainer Neumann ◽  
...  
Keyword(s):  
Breast Cancer ◽  
In Situ Hybridization ◽  
Metastatic Breast Cancer ◽  
Fluorescence In Situ Hybridization ◽  
Real Time ◽  
Metastatic Breast ◽  
Gene Copy ◽  
Primary Breast Tumor ◽  
Her 2

Abstract Background: HER-2 status is generally determined by immunohistochemistry (IHC) or fluorescence in situ hybridization (FISH). Both methods are only semiquantitative, require a tumor sample, and can be difficult to reproduce. We compared these methods with 2 quantitative approaches, one measuring HER-2 gene copy number in tissue by real-time quantitative PCR (qPCR), and the other measuring shed HER-2 protein in serum by ELISA in patients with metastatic disease. Methods: We analyzed 52 cases of metastatic breast cancer for which both serum collected at the diagnosis of metastasis and stored primary breast tumor specimens were available. The within- and between-run imprecision of real-time qPCR and ELISA were evaluated according to Clinical and Laboratory Standards Institute (formerly known as NCCLS) recommendations. Concordance among the 4 methods was assessed by calculating the κ statistic and its 95% confidence interval (95% CI). Results: The CVs for within- and between-run imprecision were both <10% with qPCR and ELISA. There was good agreement of results between qPCR and IHC (κ = 0.81; 95% CI, 0.64–0.99), qPCR and FISH (κ = 0.77; 95% CI, 0.58–0.96), ELISA and IHC (κ = 0.65; 95% CI, 0.41–0.89); and ELISA and FISH (κ = 0.69; 95% CI, 0.46–0.92). Conclusions: Measurements of HER-2 gene expression by qPCR and of serum HER-2 protein by ELISA are highly reproducible approaches for determining HER-2 status in metastatic breast cancer. In addition, ELISA eliminates the need for biopsy.

Docetaxel Combined With Trastuzumab Is an Active Regimen in HER-2 3+ Overexpressing and Fluorescent In Situ Hybridization–Positive Metastatic Breast Cancer: A Multi-Institutional Phase II Trial

2004 ◽  
Vol 22 (6) ◽  
pp. 1071-1077 ◽  
Author(s):  
K.L. Tedesco ◽  
A.D. Thor ◽  
D.H. Johnson ◽  
Y. Shyr ◽  
K.A. Blum ◽  
...  
Keyword(s):  
Breast Cancer ◽  
In Situ Hybridization ◽  
Metastatic Breast Cancer ◽  
Fluorescent In Situ Hybridization ◽  
Overall Response Rate ◽  
Response Rate ◽  
Metastatic Breast ◽  
Overall Response ◽  
Her 2

Purpose To determine the efficacy and safety of weekly docetaxel and trastuzumab as first- or second-line therapy in women with HER-2–overexpressing metastatic breast cancer and to correlate the efficacy of trastuzumab with HER-2 status as determined by immunohistochemistry assay and fluorescent in situ hybridization (FISH). Patients and Methods Twenty-six women with HER-2–positive (HercepTest [Dako Corp, Carpenteria, CA]2 to 3+) metastatic breast cancer were enrolled onto this study of trastuzumab (4 mg/kg load; 2 mg/kg/wk administered intravenously) and docetaxel (35 mg/m2/wk for 6 weeks). Results Using an intent-to-treat analysis, the overall response rate was 50% (13 of 26 patients). Eight patients (31%) had a period of stable disease posttherapy. Among HER-2 3+ patients, the overall response rate was 63% (12 of 19 patients) compared with a 14% response rate (one of seven patients) for HER-2 2+ patients (P = .07). Patients with FISH-positive tumors experienced an overall response rate of 64%. Median time to progression was 12.4 months for the entire cohort (HER-2 3+ tumors, 12.3 months; HER-2 2+ lesions, 9.5 months) and median survival was 22.1 months. All HER-2 3+ patients were FISH-positive; the only HER-2 2+ patient responding to treatment was also FISH-positive. Grade 4 toxicities occurred in four patients; most toxicities were mild. Conclusion Trastuzumab plus docetaxel is an active and well-tolerated regimen in women with HER-2 3+ overexpressing or FISH-positive metastatic breast cancer.

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