PMID- 34407587
OWN - NLM
STAT- MEDLINE
DCOM- 20210820
LR  - 20221207
IS  - 0253-3766 (Print)
IS  - 0253-3766 (Linking)
VI  - 43
IP  - 8
DP  - 2021 Aug 23
TI  - [Impact and clinical value of the revised 2019 Chinese HER-2 testing guidelines 
      on the detect result evaluation of invasive breast cancer cases with equivocal 
      HER-2 immunostaining by using fluorescence in situ hybridization].
PG  - 833-837
LID - 10.3760/cma.j.cn112152-20200309-00183 [doi]
AB  - Objective: To investigate the impact and clinical significance of the revised 
      2019 Chinese HER-2 testing guidelines on the detecting result evaluation of 
      invasive breast cancers with equivocal HER-2 immunostaining by using fluorescence 
      in situ hybridization (FISH). Methods: A total of 569 cases of invasive breast 
      cancers with HER-2 (+ + ) immunostaining evaluated according to the 
      immunohistochemistry (IHC) guidelines of 2014 edition and 2019 edition from May 
      to November 2019 were collected and further detected by FISH. The results of 
      HER-2/CEPl7 double probe were respectively interpreted according to both the 2014 
      and 2019 Chinese HER-2 testing guidelines and the results were compared. Results: 
      According to the 2014 guidelines, the number of HER-2 positive, equivocal and 
      negative cases were 139 (24.43%), 67 (11.78%), and 363 (63.80%), respectively. 
      Whereas according to the 2019 guidelines, 115 cases (20.21%) were the first 
      group, 9 cases (1.58%) were the second group, 15 cases (2.64%) were the third 
      group, 67 cases (11.78%) were the fourth group, and 363 cases were (63.80%) the 
      fifth group, of which 130 cases (22.85%) were positive and 439 cases (77.15%) 
      were negative by FISH detecting. Compared with the guideline of 2014 edition, the 
      HER-2 positive rate of FISH detection reduced from 24.43% (139/569) to 22.85% 
      (130/559) according to the application of the guideline of 2019 edition, but the 
      difference was not statistically significant (P=0.567), while the negative rate 
      increased from 63.80% (363/569) to 77.15% (439/569), with a statistically 
      significant difference (P<0.05). Forty-three cases with incomplete weak to medium 
      intensity of IHC membrane staining which were HER-2 (+ + ) according to 2014 
      guideline were changed to IHC (+ ) on the basis of the 2019 guideline. According 
      to the FISH guideline of 2014 edition, 1 case (2.33%) was positive, 6 cases 
      (13.95%) was equivocal and 36 cases (83.72%) was negative, while according to the 
      2019 FISH guideline, all of the 43 cases were negative. Conclusions: According to 
      the guideline of 2019 edition, a proportion of cases changes from HER-2 (+ + ) to 
      (+ ), and the HER-2 positive rate of FISH test decreases slightly, the negative 
      rate increases, the equivocal result is eliminated, which provides a definite 
      reference for screening patients who will be benefited from the targeted 
      treatment of HER-2.
FAU - Zhang, L
AU  - Zhang L
AD  - Department of Pathology, the First Affiliated Hospital of Zhengzhou University, 
      Zhengzhou 450000, China.
FAU - Wang, W W
AU  - Wang WW
AD  - Department of Pathology, the First Affiliated Hospital of Zhengzhou University, 
      Zhengzhou 450000, China.
FAU - Jiang, G Z
AU  - Jiang GZ
AD  - Department of Pathology, the First Affiliated Hospital of Zhengzhou University, 
      Zhengzhou 450000, China.
FAU - Zhang, Y P
AU  - Zhang YP
AD  - Department of Pathology, the First Affiliated Hospital of Zhengzhou University, 
      Zhengzhou 450000, China.
LA  - chi
GR  - 192102310057/Scientific and Technological Breakthrough Foundation of Henan 
      Province/
PT  - Journal Article
PL  - China
TA  - Zhonghua Zhong Liu Za Zhi
JT  - Zhonghua zhong liu za zhi [Chinese journal of oncology]
JID - 7910681
SB  - IM
MH  - Asian People
MH  - *Breast Neoplasms/diagnosis/genetics
MH  - China
MH  - Female
MH  - Humans
MH  - Immunohistochemistry
MH  - In Situ Hybridization, Fluorescence
OTO - NOTNLM
OT  - Breast neoplasms
OT  - Fluorescence in situ hybridization
OT  - Guideline
OT  - Human epidermal growth factor receptor 2
OT  - Immunohistochemistry
EDAT- 2021/08/19 06:00
MHDA- 2021/08/21 06:00
CRDT- 2021/08/18 22:35
PHST- 2021/08/18 22:35 [entrez]
PHST- 2021/08/19 06:00 [pubmed]
PHST- 2021/08/21 06:00 [medline]
AID - 10.3760/cma.j.cn112152-20200309-00183 [doi]
PST - ppublish
SO  - Zhonghua Zhong Liu Za Zhi. 2021 Aug 23;43(8):833-837. doi: 
      10.3760/cma.j.cn112152-20200309-00183.