Development of recurrence risk prediction model 95-gene classifier and its application to formalin-fixed paraffin-embedded tissues.

2018 Fiscal Year Final Research Report

• Project/Area Number: 16K10456
• Research Category: Grant-in-Aid for Scientific Research (C)
• Allocation Type: Multi-year Fund
• Section: 一般
• Research Field: General surgery
• Research Institution: Osaka University
• Principal Investigator: Naoi Yasuto 大阪大学, 医学系研究科, 助教 (30646211)
• Project Period (FY): 2016-04-01 – 2019-03-31
• Keywords: 乳癌 / マイクロアレイ / 再発予測 / 多遺伝子アッセイ / FFPE

Outline of Final Research Achievements

We previously developed a 95-gene classifier (95GC) to classify ER-positive, HER2-negative, and node-negative breast cancers as high and low-risk groups. Although the 95GC was originally developed using fresh-frozen (FF) tissues, we aimed to apply this to formalin-fixed paraffin-embedded (FFPE) tissues.
As the result, 95GC Recurrence Score was well correlated (R = 0.92) with FF and FFPE tissues, and the concordance rate (94.6%) of high- and low-risk groups was also considerably high. Our 95GC was applicable to FFPE tissues with a high concordance rate with FF tissues.

Free Research Field

乳腺内分泌外科学

Academic Significance and Societal Importance of the Research Achievements

本研究では、Curebest 95GCをホルマリン固定パラフィン包埋組織検体（以下、FFPE検体）にも応用可能なように改良した。本研究により95GCはFFPEに適応拡大することに成功し、2019年現在多数の病院施設からのFFPE検体を受け付けている。この事で、より多数の乳癌患者を対象に再発予後予測を施行し、癌個別化医療を実現する事ができた。またFFPE検体を多く有する米国4施設において、95GC性能検証研究を進め、良好な成績を得る事ができた。