PMID- 37728467
OWN - NLM
STAT- MEDLINE
DCOM- 20230921
LR  - 20230921
IS  - 1233-9687 (Print)
IS  - 1233-9687 (Linking)
VI  - 74
IP  - 2
DP  - 2023
TI  - Potential impact of HercepTest mAb PharmDx (Dako Omnis) (ge001) in breast cancer 
      diagnosis.
PG  - 82-88
LID - 51058 [pii]
LID - 10.5114/pjp.2023.129352 [doi]
AB  - The HER2 gene is a biomarker for breast cancer prognosis and treatment. 
      Overexpression of HER2 protein determined by immunohistochemistry (IHC) or 
      amplification of the HER2 gene determined by fluorescence in situ hybridization 
      (FISH) is a condition for qualifying patients for anti-HER2 therapy. Due to 
      the high toxicity of anti-HER2 treatment, proper patient selection is essential. 
      In our study we compared 40 cases with IHC staining of HER2 antibody determined 
      by Ventana PATHWAY anti-HER2/neu antibody (4B5) as HER2 2+ with the new antibody 
      (HercepTest mAb PharmDx [Dako Omnis] [GE001]). Then using a double-blind study 
      we compared the (IHC) evaluation with FISH results. In 65% of cases (26/40) 
      the IHC 2+ score remained unchanged, in 32.5% of cases (13/40) expression of HER2 
      protein after IHC with new antibody was indicated as 3+ score, and in one case we 
      observed a decrease of HER2 protein expression to 1+. In all cases but one, in 
      which we found IHC HER 3+ with new antibody, there was FISH amplification. We 
      have reason to believe that the new antibody will reduce the diagnostic time and 
      avoid unnecessary costs. Due to the small study group, further investigation is 
      needed.
FAU - Marszalek, Andrzej
AU  - Marszalek A
AD  - Department of Cancer Pathology, Greater Poland Cancer Centre, Poznan, Poland.
AD  - Department of Tumour Pathology and Prophylaxis, University of Medical Sciences, 
      Poznan, Poland.
FAU - Kubicka, Agata
AU  - Kubicka A
AD  - Department of Cancer Pathology, Greater Poland Cancer Centre, Poznan, Poland.
FAU - Jagiello, Inga
AU  - Jagiello I
AD  - Department of Cancer Pathology, Greater Poland Cancer Centre, Poznan, Poland.
FAU - Malicka-Durczak, Anna
AU  - Malicka-Durczak A
AD  - Department of Cancer Pathology, Greater Poland Cancer Centre, Poznan, Poland.
AD  - Department of Tumour Pathology and Prophylaxis, University of Medical Sciences, 
      Poznan, Poland.
LA  - eng
PT  - Journal Article
PL  - Poland
TA  - Pol J Pathol
JT  - Polish journal of pathology : official journal of the Polish Society of 
      Pathologists
JID - 9437432
SB  - IM
MH  - Female
MH  - Humans
MH  - Breast
MH  - *Breast Neoplasms/drug therapy
MH  - In Situ Hybridization, Fluorescence
MH  - Double-Blind Method
OTO - NOTNLM
OT  - FISH
OT  - HER2
OT  - IHC
OT  - breast cancer
EDAT- 2023/09/20 12:52
MHDA- 2023/09/21 06:42
CRDT- 2023/09/20 09:50
PHST- 2023/09/21 06:42 [medline]
PHST- 2023/09/20 12:52 [pubmed]
PHST- 2023/09/20 09:50 [entrez]
AID - 51058 [pii]
AID - 10.5114/pjp.2023.129352 [doi]
PST - ppublish
SO  - Pol J Pathol. 2023;74(2):82-88. doi: 10.5114/pjp.2023.129352.