PMID- 23418612 OWN - NLM STAT- PubMed-not-MEDLINE DCOM- 20130704 LR - 20211021 IS - 1936-5233 (Print) IS - 1936-5233 (Electronic) IS - 1936-5233 (Linking) VI - 6 IP - 1 DP - 2013 Feb TI - The Reliability of Endoscopic Biopsies in Assessing HER2 Status in Gastric and Gastroesophageal Junction Cancer: A Study Comparing Biopsies with Surgical Samples. PG - 10-6 AB - AIM: The aim of this study is to validate the accuracy of HER2 assessment on biopsies by comparing matched biopsy/surgical material from the same patients. METHODS: HER2 status was evaluated by immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH) in 103 cases of gastric and gastroesophageal junction cancers in coupled biopsy and surgical material. RESULT: Complete concordance between IHC and FISH results on biopsy versus surgical samples was noted in 80% and 95% of cases, respectively. At comprehensive comparison, including IHC and FISH data on biopsy and surgical samples, 89% of biopsies were predictive of HER2 status in surgical samples, whereas 11% showed variable inconsistencies. The majority of these (10 of 12 cases) showed IHC score 0/1+ on biopsy but were all IHC positive and amplified at surgery; in particular, three (3 of 35; 8.5%) IHC score 0 and four (4 of 16; 25%) IHC score 1+ cases were FISH amplified on biopsy material also, whereas the remaining three cases were FISH non-amplified on biopsy. The percentage of cases, which were FISH amplified with IHC score 1+ or 2+ on biopsies, were similar (25% and 33%, respectively) and they also shared a similar grade of amplification. These data suggest that both IHC score 1+ and 2+ on biopsy material represent "equivocal cases" that may merit further investigation. CONCLUSIONS: The predictive value of HER2 IHC in biopsies is high. FISH analysis should be considered for IHC score 2+ and 1+ biopsy cases. Approximately 8% of cases will not be accurately predicted by biopsy evaluation. FAU - Grillo, Federica AU - Grillo F AD - Department of Surgical and Diagnostic Sciences (DISC), Pathology Unit, University of Genoa and IRCCS San Martino-IST University Hospital, Genoa, Italy. FAU - Fassan, Matteo AU - Fassan M FAU - Ceccaroli, Chiara AU - Ceccaroli C FAU - Giacometti, Cinzia AU - Giacometti C FAU - Curto, Monica AU - Curto M FAU - Zagonel, Vittorina AU - Zagonel V FAU - Ceppa, Paola AU - Ceppa P FAU - Nitti, Donato AU - Nitti D FAU - Castoro, Carlo AU - Castoro C FAU - Fiocca, Roberto AU - Fiocca R FAU - Rugge, Massimo AU - Rugge M FAU - Mastracci, Luca AU - Mastracci L LA - eng PT - Journal Article DEP - 20130201 PL - United States TA - Transl Oncol JT - Translational oncology JID - 101472619 PMC - PMC3573649 EDAT- 2013/02/19 06:00 MHDA- 2013/02/19 06:01 PMCR- 2013/02/01 CRDT- 2013/02/19 06:00 PHST- 2012/10/08 00:00 [received] PHST- 2012/11/09 00:00 [revised] PHST- 2012/11/09 00:00 [accepted] PHST- 2013/02/19 06:00 [entrez] PHST- 2013/02/19 06:00 [pubmed] PHST- 2013/02/19 06:01 [medline] PHST- 2013/02/01 00:00 [pmc-release] AID - 12334 [pii] AID - 10.1593/tlo.12334 [doi] PST - ppublish SO - Transl Oncol. 2013 Feb;6(1):10-6. doi: 10.1593/tlo.12334. Epub 2013 Feb 1.