PMID- 33710417
OWN - NLM
STAT- MEDLINE
DCOM- 20211029
LR  - 20211029
IS  - 1559-131X (Electronic)
IS  - 1357-0560 (Print)
IS  - 1357-0560 (Linking)
VI  - 38
IP  - 4
DP  - 2021 Mar 12
TI  - Estimating copy number using next-generation sequencing to determine ERBB2 
      amplification status.
PG  - 36
LID - 10.1007/s12032-021-01482-1 [doi]
LID - 36
AB  - Assessing Erb-b2 receptor tyrosine kinase 2 (ERBB2) amplification status in 
      breast and gastric cancer is necessary for deciding the best therapeutic 
      strategy. Immunohistochemistry (IHC) and fluorescence in situ hybridization 
      (FISH) are currently used for assessing protein levels and gene copy number (CN), 
      respectively. The use of next-generation sequencing (NGS) to measure ERBB2 CN in 
      breast cancer is approved by the United States Federal Drug Administration as a 
      companion diagnostic. However, a CN of less than 8 is evaluated as "equivocal", 
      which means that some ERBB2 amplification cases diagnosed as "HER2 negative" 
      might be false-negative cases. We reviewed the results of gene profiling 
      targeting 160 cancer-related genes in breast (N = 90) and non-breast (N = 19) 
      cancer tissue, and compared the ERBB2 CN results with the IHC/FISH scores. We 
      obtained an estimated CN from the measured CN by factoring in the histological 
      proportion of tumor cells and found that an ERBB2-estimated CN of 3.2 or higher 
      was concordant with the combined IHC/FISH outcome in 98.4% (88/90) of breast 
      cancer cases, while this was not always evident among non-breast cancer cases. 
      Therefore, NGS-estimated ERBB2 CN could be considered a diagnostic test for 
      anti-HER2 therapy after the completion of adequate prospective clinical trials.
FAU - Nakamura, Kohei
AU  - Nakamura K
AUID- ORCID: 0000-0002-5162-7132
AD  - Genomics Unit, Keio Cancer Center, Keio University School of Medicine, 35 
      Shinanomachi, Shinjukuku, Tokyo, 160-8582, Japan. knakamura320@keio.jp.
AD  - Department of Biomedical Informatics, Kansai Division, Mitsubishi Space Software 
      Co., Ltd, Tokyo, Japan. knakamura320@keio.jp.
AD  - Department of Obstetrics and Gynecology, Kumagaya General Hospital, Saitama, 
      360-8657, Japan. knakamura320@keio.jp.
FAU - Aimono, Eriko
AU  - Aimono E
AD  - Genomics Unit, Keio Cancer Center, Keio University School of Medicine, 35 
      Shinanomachi, Shinjukuku, Tokyo, 160-8582, Japan.
FAU - Oba, Junna
AU  - Oba J
AD  - Genomics Unit, Keio Cancer Center, Keio University School of Medicine, 35 
      Shinanomachi, Shinjukuku, Tokyo, 160-8582, Japan.
FAU - Hayashi, Hideyuki
AU  - Hayashi H
AD  - Genomics Unit, Keio Cancer Center, Keio University School of Medicine, 35 
      Shinanomachi, Shinjukuku, Tokyo, 160-8582, Japan.
FAU - Tanishima, Shigeki
AU  - Tanishima S
AD  - Department of Biomedical Informatics, Kansai Division, Mitsubishi Space Software 
      Co., Ltd, Tokyo, Japan.
FAU - Hayashida, Tetsu
AU  - Hayashida T
AD  - Department of Surgery, Keio University School of Medicine, 35 Shinanomachi, 
      Shinjukuku, Tokyo, 160-8582, Japan.
FAU - Chiyoda, Tatsuyuki
AU  - Chiyoda T
AD  - Department of Obstetrics and Gynecology, Keio University School of Medicine, 35 
      Shinanomachi, Shinjukuku, Tokyo, 160-8582, Japan.
FAU - Kosaka, Takeo
AU  - Kosaka T
AD  - Department of Urology, Keio University School of Medicine, 35 Shinanomachi, 
      Shinjukuku, Tokyo, 160-8582, Japan.
FAU - Hishida, Tomoyuki
AU  - Hishida T
AD  - Division of Thoracic Surgery, Department of Surgery, Keio University School of 
      Medicine, 35 Shinanomachi, Shinjukuku, Tokyo, 160-8582, Japan.
FAU - Kawakubo, Hirohumi
AU  - Kawakubo H
AD  - Department of Surgery, Keio University School of Medicine, 35 Shinanomachi, 
      Shinjukuku, Tokyo, 160-8582, Japan.
FAU - Kitago, Minoru
AU  - Kitago M
AD  - Department of Surgery, Keio University School of Medicine, 35 Shinanomachi, 
      Shinjukuku, Tokyo, 160-8582, Japan.
FAU - Okabayashi, Koji
AU  - Okabayashi K
AD  - Department of Surgery, Keio University School of Medicine, 35 Shinanomachi, 
      Shinjukuku, Tokyo, 160-8582, Japan.
FAU - Funakoshi, Takeru
AU  - Funakoshi T
AD  - Department of Dermatology, Keio University School of Medicine, 35 Shinanomachi, 
      Shinjukuku, Tokyo, 160-8582, Japan.
FAU - Okita, Hajime
AU  - Okita H
AD  - Department of Diagnostic Pathology, Keio University School of Medicine, 35 
      Shinanomachi, Shinjukuku, Tokyo, 160-8582, Japan.
FAU - Ikeda, Sadakatsu
AU  - Ikeda S
AD  - Cancer Center, Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyo-ku, 
      Tokyo, 110-8510, Japan.
FAU - Takaishi, Hiromasa
AU  - Takaishi H
AD  - Keio Cancer Center, Keio University School of Medicine, 35 Shinanomachi, 
      Shinjukuku, Tokyo, 160-8582, Japan.
FAU - Nishihara, Hiroshi
AU  - Nishihara H
AD  - Genomics Unit, Keio Cancer Center, Keio University School of Medicine, 35 
      Shinanomachi, Shinjukuku, Tokyo, 160-8582, Japan.
LA  - eng
GR  - 20K18232/Japan Society for the Promotion of Science/
GR  - JP20mk0102145/Japan Agency for Medical Research and Development/
GR  - 20ck0106448h0003/Japan Agency for Medical Research and Development/
PT  - Journal Article
DEP - 20210312
PL  - United States
TA  - Med Oncol
JT  - Medical oncology (Northwood, London, England)
JID - 9435512
RN  - 0 (Biomarkers, Tumor)
RN  - EC 2.7.10.1 (ERBB2 protein, human)
RN  - EC 2.7.10.1 (Receptor, ErbB-2)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Biomarkers, Tumor/genetics/metabolism
MH  - Breast Neoplasms/diagnosis/*genetics/metabolism
MH  - Female
MH  - Gene Amplification/*genetics
MH  - Gene Dosage
MH  - Genetic Testing/standards
MH  - *High-Throughput Nucleotide Sequencing
MH  - Humans
MH  - Immunohistochemistry
MH  - In Situ Hybridization, Fluorescence
MH  - Middle Aged
MH  - Neoplasms/diagnosis/genetics/metabolism
MH  - Receptor, ErbB-2/*genetics/metabolism
PMC - PMC7954749
OTO - NOTNLM
OT  - Breast cancer
OT  - ERBB2
OT  - Gene copy number
OT  - Immunohistochemistry
OT  - Next-generation sequencing
COIS- The authors declare no conflict of interest. The funders had no role in the 
      design of the study; in the collection, analyses, or interpretation of data; in 
      the writing of the manuscript, or in the decision to publish the results.
EDAT- 2021/03/13 06:00
MHDA- 2021/10/30 06:00
PMCR- 2021/03/12
CRDT- 2021/03/12 12:44
PHST- 2021/01/03 00:00 [received]
PHST- 2021/02/13 00:00 [accepted]
PHST- 2021/03/12 12:44 [entrez]
PHST- 2021/03/13 06:00 [pubmed]
PHST- 2021/10/30 06:00 [medline]
PHST- 2021/03/12 00:00 [pmc-release]
AID - 10.1007/s12032-021-01482-1 [pii]
AID - 1482 [pii]
AID - 10.1007/s12032-021-01482-1 [doi]
PST - epublish
SO  - Med Oncol. 2021 Mar 12;38(4):36. doi: 10.1007/s12032-021-01482-1.