Abstract 159P
Background
Screening for lung cancer using imaging modalities such as low-dose CT (LDCT) is currently recommended only for high-risk populations. However, the proportion of lung cancer in never-smokers in East Asia, including Japan, is comparatively higher. This study aims to develop and validate a minimally invasive blood test for identifying high-risk individuals who should undergo further diagnostic tests to improve early detection of lung cancer in a Japanese population comprising smokers and never-smokers.
Methods
We conducted a multi-centre case-control study in Japan to prospectively collect plasma samples from a total of 287 lung cancer patients, of which more than 70% had stage I disease, and 327 matched healthy controls. The samples from three centres were divided into two cohorts for optimization and validation of a 12-microRNA (miRNA) plasma biomarker panel developed for early detection of lung cancer. Both cohorts included at least 40% never-smokers. The miRNA quantities were measured using RT-qPCR and performance for detection of lung cancer was assessed using the area under ROC curve (AUC).
Results
The circulating miRNA biomarker panel achieved a maximum AUC of 0.83 for detection of lung cancer in the optimization cohort. The diagnostic performance of the 12-miRNA panel was then further validated in an independent cohort with AUC of 0.76 for detecting all stages of lung cancer. The AUC for detecting stage I lung cancer was 0.75 while AUC for stage II-IV lung cancers was 0.79. Performance was robust across gender and smoking status and was enhanced when the miRNA panel was used in combination with carcinoembryonic antigen (CEA) expression level by ECLIA.
Conclusions
We optimized and validated a circulating miRNA biomarker panel for use as a minimally invasive blood test to aid in the early detection of lung cancer in a Japanese population. This plasma 12-miRNA panel has the potential to complement existing image-based methods currently used for lung cancer screening and diagnosis and improve detection of early stage (stage I) lung cancer, especially when used in combination with biomarkers like CEA. This research was supported by MiRXES.
Legal entity responsible for the study
MiRXES.
Funding
MiRXES.
Disclosure
M. Tsuboi: Financial Interests, Personal, Invited Speaker, Lecture: Johnson & Johnson Japan; Financial Interests, Personal, Advisory Board, Lectures, Advisory boards: AstraZeneca KK, Chugai Pharmaceutical CO., LTD, MSD; Financial Interests, Personal, Invited Speaker, Lectures: Eli Lilly Japan, Bristol-Myers Squibb KK, Teijin Pharma, Taiho Pharma, Medtronic Japan, ONO Pharmaceutical CO., LTD; Financial Interests, Personal, Advisory Board, Advisory boards: Novartis; Financial Interests, Personal, Invited Speaker: Daiichi-Sankyo company limited, MSD, AstraZeneca, Novartis; Financial Interests, Institutional, Research Grant: Boehringer Ingelheim Japan, MSD, AstraZeneca KK, Ono Pharmaceutical CO., LTD, Bristol-Myers Squibb KK, Novartis; Financial Interests, Institutional, Invited Speaker: Eli Lilly Japan. All other authors have declared no conflicts of interest.