PMID- 31144151 OWN - NLM STAT- MEDLINE DCOM- 20191220 LR - 20211027 IS - 1573-7217 (Electronic) IS - 0167-6806 (Print) IS - 0167-6806 (Linking) VI - 177 IP - 1 DP - 2019 Aug TI - Pathologic complete response rate according to HER2 detection methods in HER2-positive breast cancer treated with neoadjuvant systemic therapy. PG - 61-66 LID - 10.1007/s10549-019-05295-9 [doi] AB - PURPOSE: Human epidermal growth factor receptor 2 (HER2)-positive breast cancers are known to have significant clinical and pathological response to neoadjuvant systemic therapy (NST). The aim of this study was to identify factors associated with pathological complete response (pCR), defined as no residual invasive carcinoma in the breast and axillary lymph nodes (ypT0/is ypN0), among patients with HER2-positive breast cancer and to compare pCR rates between breast cancers with HER2 protein overexpression by immunohistochemistry (IHC) versus HER2 gene amplification by fluorescence in situ hybridization (FISH) in the absence of protein overexpression by IHC. METHODS: We conducted a retrospective review of HER2-positive breast cancer patients treated with NST and surgery at Memorial Sloan Kettering Cancer Center between January 2013 and May 2018. Estrogen receptor (ER), progesterone receptor (PR), and HER2 status were assessed according to the 2018 ASCO/CAP guidelines. RESULTS: During the study period, 560 patients were identified. Of 531 patients with IHC results available, 455 patients had HER2 IHC 3+, and 76 had IHC < 3+ but HER2 amplification detected by FISH. The overall pCR rate was 59% (330/560). The pCR rate among patients with HER2 protein overexpression (IHC 3+) was 67%, compared to 17% among patients with HER2 amplification by FISH (IHC < 3+). On univariate and multivariate analyses, HER2 protein overexpression by IHC (IHC 3+) was a significant predictor of pCR, along with grade 3 histology, PR-negative status, and dual anti-HER2 therapy. CONCLUSION: Although both HER2 IHC and FISH are standard HER2 testing methods in breast cancer, achievement of pCR is associated with HER2 IHC expression level, among other factors. FAU - Krystel-Whittemore, Melissa AU - Krystel-Whittemore M AD - Department of Pathology, Massachusetts General Hospital, Boston, MA, USA. FAU - Xu, Jin AU - Xu J AD - Department of Pathology, Memorial Sloan Kettering Cancer, 1275 York Avenue, New York, NY, 10065, USA. FAU - Brogi, Edi AU - Brogi E AD - Department of Pathology, Memorial Sloan Kettering Cancer, 1275 York Avenue, New York, NY, 10065, USA. FAU - Ventura, Katia AU - Ventura K AD - Department of Pathology, Memorial Sloan Kettering Cancer, 1275 York Avenue, New York, NY, 10065, USA. FAU - Patil, Sujata AU - Patil S AD - Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer, New York, NY, USA. FAU - Ross, Dara S AU - Ross DS AD - Department of Pathology, Memorial Sloan Kettering Cancer, 1275 York Avenue, New York, NY, 10065, USA. FAU - Dang, Chau AU - Dang C AD - Department of Medicine, Memorial Sloan Kettering Cancer, New York, NY, USA. FAU - Robson, Mark AU - Robson M AD - Department of Medicine, Memorial Sloan Kettering Cancer, New York, NY, USA. FAU - Norton, Larry AU - Norton L AD - Department of Medicine, Memorial Sloan Kettering Cancer, New York, NY, USA. FAU - Morrow, Monica AU - Morrow M AD - Department of Surgery, Memorial Sloan Kettering Cancer, New York, NY, USA. FAU - Wen, Hannah Y AU - Wen HY AUID- ORCID: 0000-0001-6794-5234 AD - Department of Pathology, Memorial Sloan Kettering Cancer, 1275 York Avenue, New York, NY, 10065, USA. weny@mskcc.org. LA - eng GR - P30 CA008748/CA/NCI NIH HHS/United States GR - P30CA008748/National Cancer Institute/ PT - Journal Article DEP - 20190529 PL - Netherlands TA - Breast Cancer Res Treat JT - Breast cancer research and treatment JID - 8111104 RN - 0 (Biomarkers, Tumor) RN - 0 (Receptors, Estrogen) RN - 0 (Receptors, Progesterone) RN - EC 2.7.10.1 (ERBB2 protein, human) RN - EC 2.7.10.1 (Receptor, ErbB-2) SB - IM MH - Adult MH - *Biomarkers, Tumor MH - Biopsy, Large-Core Needle MH - Breast Neoplasms/*genetics/mortality/pathology/*therapy MH - Combined Modality Therapy MH - Female MH - Humans MH - Immunohistochemistry MH - In Situ Hybridization, Fluorescence MH - Middle Aged MH - Neoadjuvant Therapy MH - Neoplasm Grading MH - Neoplasm Staging MH - Prognosis MH - Receptor, ErbB-2/*genetics/metabolism MH - Receptors, Estrogen/genetics/metabolism MH - Receptors, Progesterone/genetics/metabolism MH - Retrospective Studies MH - Treatment Outcome PMC - PMC6640097 MID - NIHMS1530466 OTO - NOTNLM OT - HER2 assessment OT - HER2-positive breast cancer OT - Human epidermal growth factor receptor 2 OT - Neoadjuvant systemic therapy OT - Pathologic complete response COIS- Conflict of Interest: The authors have no conflict of interest to disclose. EDAT- 2019/05/31 06:00 MHDA- 2019/12/21 06:00 PMCR- 2020/08/01 CRDT- 2019/05/31 06:00 PHST- 2019/04/06 00:00 [received] PHST- 2019/05/23 00:00 [accepted] PHST- 2019/05/31 06:00 [pubmed] PHST- 2019/12/21 06:00 [medline] PHST- 2019/05/31 06:00 [entrez] PHST- 2020/08/01 00:00 [pmc-release] AID - 10.1007/s10549-019-05295-9 [pii] AID - 10.1007/s10549-019-05295-9 [doi] PST - ppublish SO - Breast Cancer Res Treat. 2019 Aug;177(1):61-66. doi: 10.1007/s10549-019-05295-9. Epub 2019 May 29.