PMID- 19919879 OWN - NLM STAT- MEDLINE DCOM- 20100205 LR - 20161125 IS - 1095-6859 (Electronic) IS - 0090-8258 (Linking) VI - 116 IP - 2 DP - 2010 Feb TI - Preoperative assessment of HER-2/neu status in breast carcinoma: the role of quantitative real-time PCR on core-biopsy specimens. PG - 234-9 LID - 10.1016/j.ygyno.2009.10.067 [doi] AB - OBJECTIVES: Knowledge of HER-2/neu status is mandatory to identify breast cancer patients amenable to trastuzumab treatment. We evaluated the diagnostic performance of quantitative real-time polymerase chain reaction (qRT-PCR) in the preoperative determination of HER-2/neu status in breast cancer, using core biopsy material. METHODS: In a prospective series, qRT-PCR was performed on fresh core biopsy specimens taken preoperatively in 87 patients with breast carcinoma. Cases with qRT-PCR ratio > or = 2.0 were considered to have HER-2/neu amplification. The results of RT-PCR analysis were compared with those of the standard immunohistochemistry (IHC) and Fluorescence in situ hybridization (FISH) methods. Cases with IHC 3+ or with IHC 2+ and FISH showing amplification were considered HER-2/neu positive. All other cases were considered HER-2/neu negative. RESULTS: qRT-PCR showed HER-2/neu amplification in 13 cases (14.9%), while the standard IHC-FISH combined approach identified 17 HER-2/neu-positive cases (19.5%). Overall, there was concordance between methods in 83 of 87 patients (95.4%). The Spearman's rho correlation coefficient was 0.851; p<0.001. The diagnostic performance for preoperative diagnosis of HER-2/neu status using RT-PCR on core biopsy specimens as compared to standard approach was as follows: sensitivity 76.5%; specificity 100%; positive predictive value 100%; negative predictive value 94.6%. CONCLUSIONS: Quantitative RT-PCR determination of HER-2/neu status from core biopsy specimens provided results comparable to those given by the standard IHC and FISH methods. The use of qRT-PCR on core biopsy material may represent a very useful and easy tool to enhance early identification of HER-2/neu-positive breast cancer patients who, possibly can benefit from trastuzumab treatment. CI - Copyright 2009 Elsevier Inc. All rights reserved. FAU - Susini, Tommaso AU - Susini T AD - Department of Gynecology, Perinatology and Human Reproduction, University of Florence, Viale Morgagni, 85 - 50134, Firenze, Italy. tommaso.susini@unifi.it FAU - Bussani, Cecilia AU - Bussani C FAU - Marini, Giulia AU - Marini G FAU - Nori, Jacopo AU - Nori J FAU - Olivieri, Simone AU - Olivieri S FAU - Molino, Cecilia AU - Molino C FAU - Bianchi, Simonetta AU - Bianchi S FAU - Vezzosi, Vania AU - Vezzosi V FAU - Paglierani, Milena AU - Paglierani M FAU - Giachi, Massimo AU - Giachi M FAU - Borrani, Elena AU - Borrani E FAU - Scarselli, Gianfranco AU - Scarselli G LA - eng PT - Journal Article DEP - 20091117 PL - United States TA - Gynecol Oncol JT - Gynecologic oncology JID - 0365304 RN - EC 2.7.10.1 (Receptor, ErbB-2) SB - IM MH - Biopsy/methods MH - Breast Neoplasms/diagnostic imaging/*enzymology/genetics MH - Female MH - Gene Amplification MH - Humans MH - Immunohistochemistry MH - In Situ Hybridization, Fluorescence MH - Prospective Studies MH - Receptor, ErbB-2/biosynthesis/*genetics MH - Reverse Transcriptase Polymerase Chain Reaction/*methods MH - Ultrasonography EDAT- 2009/11/19 06:00 MHDA- 2010/02/06 06:00 CRDT- 2009/11/19 06:00 PHST- 2009/08/20 00:00 [received] PHST- 2009/10/16 00:00 [revised] PHST- 2009/10/19 00:00 [accepted] PHST- 2009/11/19 06:00 [entrez] PHST- 2009/11/19 06:00 [pubmed] PHST- 2010/02/06 06:00 [medline] AID - S0090-8258(09)00871-3 [pii] AID - 10.1016/j.ygyno.2009.10.067 [doi] PST - ppublish SO - Gynecol Oncol. 2010 Feb;116(2):234-9. doi: 10.1016/j.ygyno.2009.10.067. Epub 2009 Nov 17.