Development of quantitative determination method for HER2 overexpression by immunohistochemistry

2021 Fiscal Year Final Research Report

• Project/Area Number: 19K16549
• Research Category: Grant-in-Aid for Early-Career Scientists
• Allocation Type: Multi-year Fund
• Review Section: Basic Section 49020:Human pathology-related
• Research Institution: Akita University
• Principal Investigator: Terata Kaori 秋田大学, 医学部附属病院, 講師 (60610748)
• Project Period (FY): 2019-04-01 – 2022-03-31
• Keywords: 乳癌 / HER2 / 免疫染色 / コントロール

Outline of Final Research Achievements

Overexpression of HER2 protein in breast cancer cells is crucial as it is a prognostic factor and a target for molecular targeted therapies. The diagnosis of HER2 protein overexpression is determined by immunohistochemistry based on the staining intensity of the cancer cell membrane, but there is a large qualitative factor based on the subjectivity of the pathologist, and there is no method for objectively and quantitatively determining the staining intensity. In order to improve the diagnostic accuracy, it is desired to establish a positive control regarding the staining intensity. This time, we aimed to improve the new positive control by applying the polymer gel generation technology and to put into practical use the quantitative immunohistochemical diagnosis of HER2 protein overexpression by fusing the image analysis technology.

Free Research Field

乳腺外科

Academic Significance and Societal Importance of the Research Achievements

現在、HER2陽性乳癌に対しては新規薬剤(TDXdをはじめとする分子標的薬、ADC薬)が開発されてきており、その進歩は目覚ましい。これまでは免疫染色によるHER2 score3、または2かつISH法で陽性を示した場合に、抗HER2薬は適応となったが、新規薬剤は、HER2 score1以上にも適応が拡大されつつある。抗HER2療法が適応の場合、治療奏効割合は高く、治療の機会を逸することがないように対応することが望まれている。本研究は現在求められているHER2過剰発現診断の標準化に貢献するものと考える。