PMID- 25378949 OWN - NLM STAT- PubMed-not-MEDLINE DCOM- 20141107 LR - 20220316 IS - 1179-1314 (Print) IS - 1179-1314 (Electronic) IS - 1179-1314 (Linking) VI - 6 DP - 2014 TI - Assessment of HER2 testing patterns, HER2+ disease, and the utilization of HER2-directed therapy in early breast cancer. PG - 169-77 LID - 10.2147/BCTT.S69416 [doi] AB - CONTEXT: Determining human epidermal growth factor receptor 2 (HER2) status is critical for the management of early-stage breast cancer (ESBC). An understanding of HER2 testing practices can provide insight into how test results influence the use of HER2-directed therapy. OBJECTIVE: To assess HER2 testing, HER2+ disease, and HER2-directed therapy in ESBC at the Huntsman Cancer Institute before and after the 2007 American Society of Clinical Oncology and College of American Pathologist (ASCO/CAP) guidelines on HER2 testing were published. METHODS: Patients were identified from an institutional tumor registry. HER2 testing patterns and results were examined using a chart review of pathology and clinical notes. Patient characteristics, HER2+ rate, and trastuzumab use were evaluated descriptively. Discordance rate with reflex testing (immunohistochemistry [IHC]2+ retested by fluorescence in situ hybridization [FISH]) was also evaluated. RESULTS: A total of 1,459 women were included (mean age: 57 years). The rate of HER2+ disease was 17% (number [N] =245). The discordance rate between IHC2+ and FISH was 10%. After the 2007 ASCO/CAP guidelines, fewer tumors were classified as IHC3+ (16% post- versus 21.9% pre-2007), more tumors were characterized as IHC2+ (26.4% post- versus 20.7% pre-2007), and the overall HER2+ rate was decreased (18.7% versus 21.9%), but this was not statistically significant (P=0.519). Most patients with HER2+ ESBC received HER2-targeted therapy (N=185). CONCLUSION: The HER2+ rate was 17% and within the range of the reported rates in the literature. Reflex testing identified additional HER2+ tumors by approximately 10%, and should be considered a potential quality indicator. ASCO/CAP HER2 testing guidelines in 2007 appeared to impact the interpretation and classification of HER2+ tumors. FAU - Stenehjem, David D AU - Stenehjem DD AD - Pharmacotherapy Outcomes Research Center (PORC), College of Pharmacy, University of Utah, Salt Lake City, UT, USA ; Huntsman Cancer Institute, Salt Lake City, UT, USA. FAU - Yoo, Minkyoung AU - Yoo M AD - Pharmacotherapy Outcomes Research Center (PORC), College of Pharmacy, University of Utah, Salt Lake City, UT, USA. FAU - Unni, Sudhir K AU - Unni SK AD - Pharmacotherapy Outcomes Research Center (PORC), College of Pharmacy, University of Utah, Salt Lake City, UT, USA. FAU - Singhal, Mukul AU - Singhal M AD - Pharmacotherapy Outcomes Research Center (PORC), College of Pharmacy, University of Utah, Salt Lake City, UT, USA. FAU - Bauer, Hillevi AU - Bauer H AD - Pharmacotherapy Outcomes Research Center (PORC), College of Pharmacy, University of Utah, Salt Lake City, UT, USA. FAU - Saverno, Kim AU - Saverno K AD - Pharmacotherapy Outcomes Research Center (PORC), College of Pharmacy, University of Utah, Salt Lake City, UT, USA. FAU - Quah, Cheng AU - Quah C AD - Genentech, Inc., South San Francisco, CA, USA. FAU - Masaquel, Anthony AU - Masaquel A AD - Genentech, Inc., South San Francisco, CA, USA. FAU - Brixner, Diana I AU - Brixner DI AD - Pharmacotherapy Outcomes Research Center (PORC), College of Pharmacy, University of Utah, Salt Lake City, UT, USA ; Program in Personalized Health Care, University of Utah, Salt Lake City, UT, USA. LA - eng PT - Journal Article DEP - 20141029 PL - New Zealand TA - Breast Cancer (Dove Med Press) JT - Breast cancer (Dove Medical Press) JID - 101591856 PMC - PMC4218922 OTO - NOTNLM OT - FISH OT - HER2 OT - HER2-targeted therapy OT - early-stage breast cancer OT - human epidermal growth factor receptor 2 OT - immunohistochemistry EDAT- 2014/11/08 06:00 MHDA- 2014/11/08 06:01 PMCR- 2014/10/29 CRDT- 2014/11/08 06:00 PHST- 2014/11/08 06:00 [entrez] PHST- 2014/11/08 06:00 [pubmed] PHST- 2014/11/08 06:01 [medline] PHST- 2014/10/29 00:00 [pmc-release] AID - bctt-6-169 [pii] AID - 10.2147/BCTT.S69416 [doi] PST - epublish SO - Breast Cancer (Dove Med Press). 2014 Oct 29;6:169-77. doi: 10.2147/BCTT.S69416. eCollection 2014.