PMID- 27081877 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20220425 IS - 1543-2165 (Electronic) IS - 0003-9985 (Print) IS - 0003-9985 (Linking) VI - 140 IP - 11 DP - 2016 Nov TI - Assessing the New American Society of Clinical Oncology/College of American Pathologists Guidelines for HER2 Testing by Fluorescence In Situ Hybridization: Experience of an Academic Consultation Practice. PG - 1250-1258 AB - Context .- Evaluation of HER2 gene amplification by fluorescence in situ hybridization (FISH) was changed by recent American Society of Clinical Oncology/College of American Pathologists (ASCO-CAP) guidelines. Objective . -To determine frequencies and assess patterns of HER2 protein expression for each ASCO-CAP guideline FISH category among 7526 breast cancers accrued to our consultation practice. Design .- We retrospectively reevaluated the HER2 FISH status of breast cancers in our consultation practice according to ASCO-CAP FISH guidelines, and documented HER2 protein levels in each category. Results . -According to new guidelines, 17.7% of our consultation breast cancers were "ISH-positive" with HER2:CEP17 FISH ratios >/=2.0 and average HER2 gene copies per cell >/=4.0 (group 1); 0.4% were "ISH-positive" with ratios >/=2.0 and average copies <4.0 (group 2); 0.6% were "ISH-positive" with ratios <2.0 and average copies >/=6.0 (group 3); 4.6% were "ISH-equivocal" with ratios <2.0 and average copies >/=4.0 and <6.0 (group 4); and 76.7% were "ISH-negative" with ratios <2.0 and average copies <4.0 (group 5). However, only groups 1 (HER2 amplified) and 5 (HER2 not amplified) agreed with our previously reported status, and only these groups demonstrated the expected immunohistochemistry status, overexpression and low expression, respectively. Groups 2 and 4 breast cancers lacked overexpression, whereas group 3 was not significantly associated with either increased or decreased HER2 expression. Conclusions .- Although the status of approximately 95% of our cases (groups 1 and 5) is not affected by the new guidelines, those of the other 5% (groups 2-4) conflict with previous HER2 gene amplification status and with HER2 status by immunohistochemistry. FAU - Press, Michael F AU - Press MF FAU - Villalobos, Ivonne AU - Villalobos I FAU - Santiago, Angela AU - Santiago A FAU - Guzman, Roberta AU - Guzman R FAU - Cervantes, Monica AU - Cervantes M FAU - Gasparyan, Armen AU - Gasparyan A FAU - Campeau, Anaamika AU - Campeau A FAU - Ma, Yanling AU - Ma Y FAU - Tsao-Wei, Denice D AU - Tsao-Wei DD FAU - Groshen, Susan AU - Groshen S AD - From the Departments of Pathology (Drs Press and Ma; Mss Villalobos, Santiago, Guzman, Cervantes, and Campeau; and Mr Gasparyan) and Preventive Medicine (Ms Tsao-Wei and Dr Groshen), Norris Comprehensive Cancer Center, University of Southern California, Los Angeles. LA - eng GR - P30 CA014089/CA/NCI NIH HHS/United States PT - Journal Article DEP - 20160415 PL - United States TA - Arch Pathol Lab Med JT - Archives of pathology & laboratory medicine JID - 7607091 PMC - PMC9022709 MID - NIHMS1622216 EDAT- 2016/04/16 06:00 MHDA- 2016/04/16 06:01 PMCR- 2022/04/21 CRDT- 2016/04/16 06:00 PHST- 2016/04/16 06:00 [entrez] PHST- 2016/04/16 06:00 [pubmed] PHST- 2016/04/16 06:01 [medline] PHST- 2022/04/21 00:00 [pmc-release] AID - 10.5858/arpa.2016-0009-OA [doi] PST - ppublish SO - Arch Pathol Lab Med. 2016 Nov;140(11):1250-1258. doi: 10.5858/arpa.2016-0009-OA. Epub 2016 Apr 15.