Evaluation of a quantitative RT-PCR assay to detect HER2 mRNA overexpression for diagnosis and selection of trastuzumab therapy in breast cancer tissue samples

Hye-Young Wang; Sunghyun Kim; Sangjung Park; Seungil Kim; Dongju Jung; Kwang Hwa Park; Hyeyoung Lee

doi:10.1016/j.yexmp.2014.09.011

Evaluation of a quantitative RT-PCR assay to detect HER2 mRNA overexpression for diagnosis and selection of trastuzumab therapy in breast cancer tissue samples

Exp Mol Pathol. 2014 Dec;97(3):368-74. doi: 10.1016/j.yexmp.2014.09.011. Epub 2014 Sep 16.

Authors

Hye-Young Wang¹, Sunghyun Kim², Sangjung Park³, Seungil Kim⁴, Dongju Jung⁵, Kwang Hwa Park⁶, Hyeyoung Lee⁷

Affiliations

¹ M&D, Inc., Wonju Eco Environmental Technology Center, Wonju, Gangwon, Republic of Korea.
² Department of Biomedical Laboratory Science, College of Health Sciences, Yonsei University, Wonju, Gangwon, Republic of Korea; Institute for Life Science and Biotechnology, Yonsei University, Seoul, Republic of Korea.
³ Department of Biomedical Laboratory Science, College of Health Sciences, Yonsei University, Wonju, Gangwon, Republic of Korea; Department of Clinical Laboratory Science, College of Medical Science, Daegu Haany University, Daegu, Republic of Korea.
⁴ Department of Surgery, Yonsei University College of Medicine, Seoul, Republic of Korea.
⁵ Department of Biomedical Laboratory Science, College of Natural Sciences, Hoseo University, Chungnam, Republic of Korea.
⁶ Department of Pathology, Wonju College of Medicine, Yonsei University, Wonju, Gangwon, Republic of Korea. Electronic address: [email protected].
⁷ Department of Biomedical Laboratory Science, College of Health Sciences, Yonsei University, Wonju, Gangwon, Republic of Korea. Electronic address: [email protected].

PMID: 25236569
DOI: 10.1016/j.yexmp.2014.09.011

Abstract

Breast cancer patients who have a positive result for HER2 overexpression are commonly treated with Herceptin, a HER2-targeted therapy. In the present study, the BrightGen HER2 RT-qDx (Syantra, Calgary, Canada), which is based on a one-tube nested RT-qPCR method that detects HER2 mRNA overexpression, was clinically evaluated in a total of 237 formalin-fixed paraffin-embedded (FFPE) tissue samples from breast cancer patients. Among the 38 HER2 positive samples, which were determined via IHC/FISH methods, 13 samples out of 16 (81.3%) that were IHC2+/FISH+ and 22 samples out of 22 (100%) that were IHC3+ have been decided positive for HER2 expression via the RT-qPCR method. The true positivity and false positivity results for the RT-qPCR were 92% (35/38) and 2% (1/65), respectively. The concordance between RT-qPCR and IHC results and RT-qPCR and IHC/FISH was 87.2% and 92.1%, respectively. Conclusively, the BrightGen HER2 RT-qDx may be a reliable and convenient method that can supplement traditional IHC and FISH methods for efficient use of trastuzumab.

Keywords: Breast cancer; FFPE tissue; HER2; Herceptin (trastuzumab); Molecular diagnosis; RT-qPCR.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Adolescent
Adult
Aged
Aged, 80 and over
Antibodies, Monoclonal, Humanized / therapeutic use
Antineoplastic Agents / therapeutic use
Breast Neoplasms / diagnosis*
Breast Neoplasms / drug therapy
Female
Genes, erbB-2
Humans
Immunohistochemistry
In Situ Hybridization, Fluorescence
Middle Aged
Molecular Targeted Therapy / methods*
Polymerase Chain Reaction / methods*
RNA, Messenger / analysis*
Receptor, ErbB-2 / analysis*
Sensitivity and Specificity
Trastuzumab
Young Adult

Substances

Antibodies, Monoclonal, Humanized
Antineoplastic Agents
RNA, Messenger
Receptor, ErbB-2
Trastuzumab