PMID- 15269154 OWN - NLM STAT- MEDLINE DCOM- 20050119 LR - 20141120 IS - 1078-0432 (Print) IS - 1078-0432 (Linking) VI - 10 IP - 14 DP - 2004 Jul 15 TI - Interlaboratory comparison of HER-2 oncogene amplification as detected by chromogenic and fluorescence in situ hybridization. PG - 4793-8 AB - PURPOSE: Chromogenic in situ hybridization (CISH) is a new modification of the fluorescence in situ hybridization (FISH) technique for detection of oncogene amplification in archival tumor samples. In CISH, the oncogene probe is detected using a peroxidase reaction, allowing use of transmitted light microscopy. We compared detection of HER-2/neu amplification by CISH with a Food and Drug Administration-approved two-color FISH test in an interlaboratory setting. EXPERIMENTAL DESIGN: Formalin-fixed paraffin-embedded tumor samples from 197 breast cancers were analyzed for HER-2 amplification by CISH. Two-color FISH (PathVysion) CISH of 17 centromere was done if the observer considered it necessary to ascertain amplification status in tumors with borderline HER-2 CISH copy numbers. RESULTS: Paired CISH/FISH results were available from 192 (97%) of 197 cases, no clear difference in success rates of either method was observed. Centromere 17 CISH was considered necessary in seven tumors. CISH and two-color FISH results were concordant in 180 cases (93.8%). There were 92 and 88 tumors found HER-2 amplified and nonamplified, respectively, by both methods. Eight tumors were amplified by CISH but not by FISH, and four tumors exhibited the opposite condition (kappa coefficient 0.875). In 7 of 12 cases differences between the two methods could have related to a lack of CISH chromosome 17 information. The remaining cases were explained by difficult histology (ductal carcinoma in situ, poor representativity, dense lymphocytic infiltration, or intratumoral heterogeneity). CONCLUSIONS: These results indicate that CISH could provide an accurate and practical alternative to FISH for clinical diagnosis of HER-2/neu oncogene amplification in archival formalin-fixed breast cancer samples. FAU - Isola, Jorma AU - Isola J AD - Laboratory of Cancer Genetics, Institute of Medical Technology, University and University Hospital of Tampere, Tampere, Finland. FAU - Tanner, Minna AU - Tanner M FAU - Forsyth, Amanda AU - Forsyth A FAU - Cooke, Timothy G AU - Cooke TG FAU - Watters, Amanda D AU - Watters AD FAU - Bartlett, John M S AU - Bartlett JM LA - eng PT - Comparative Study PT - Journal Article PL - United States TA - Clin Cancer Res JT - Clinical cancer research : an official journal of the American Association for Cancer Research JID - 9502500 RN - EC 2.7.10.1 (Receptor, ErbB-2) SB - IM MH - Breast Neoplasms/genetics/pathology MH - Chromosome Painting/*methods MH - Clinical Laboratory Techniques/standards MH - Female MH - Gene Amplification MH - Humans MH - In Situ Hybridization, Fluorescence/*methods MH - Receptor, ErbB-2/*genetics MH - Reproducibility of Results EDAT- 2004/07/23 05:00 MHDA- 2005/01/20 09:00 CRDT- 2004/07/23 05:00 PHST- 2004/07/23 05:00 [pubmed] PHST- 2005/01/20 09:00 [medline] PHST- 2004/07/23 05:00 [entrez] AID - 10/14/4793 [pii] AID - 10.1158/1078-0432.CCR-0428-03 [doi] PST - ppublish SO - Clin Cancer Res. 2004 Jul 15;10(14):4793-8. doi: 10.1158/1078-0432.CCR-0428-03.