Effectiveness of Cell-Free Tumor DNA Tests in Early Lung Cancer Detection
Author(s)
Mahesh Maiyani, MBA;
Cu Anschutz Colorado, PhD student, Aurora, CO, USA
Cu Anschutz Colorado, PhD student, Aurora, CO, USA
Presentation Documents
OBJECTIVES: The U.S. Preventive Services Task Force recommends annual low-dose computed tomography (LDCT) lung cancer screening for adults 50-80 who are current smokers or quit within 15 years, with 20 pack-years smoking history. This single-arm study evaluated detecting lung cancer during LDCT screening using Guardant Health’s LUNARTM-2 cell-free tumor DNA assay.
METHODS: Kaiser Permanente Colorado members scheduled for LDCT screening were contacted via email/phone and grouped into (1) suspicious lung nodules or (2) no lung nodules. Enrollment was limited to patients with Lung-RADS (Reporting and Data System, version 1.0) categories 1-3 (12-month follow-up) or category 4 (suspicious, 3-month follow-up). Members with lung nodules>30mm, hematologic malignancies, invasive cancers within 5 years, pregnancy, or cognitive impairment were excluded. After consent, Guardant Health LUNARTM-2 test kits were mailed with instructions. Blood samples were collected on the LDCT visit day or within 14 days. Survey and HER data on smoking, LDCT, and related factors were also collected.
RESULTS: Out of 872 consented individuals who provided blood samples, 84 were ineligible for the study. Among the final analytic cohort of 788 participants, 18 were diagnosed with lung cancer, 23 with other cancer, and 747 were cancer-free; all returned their biospecimens within 30 days of their LDCT scan. Participants are, on average, 68 years old, 56% female, 54% former smokers, and 87% have no personal history of cancer. Those diagnosed with lung cancer were older, had more pack-years of tobacco use, and had a higher frequency of prior cancer compared to those who remained cancer-free. Assay performance, overall and by cancer characteristics, are being calculated and will be reported in the poster.
CONCLUSIONS: This proof-of-concept study will confirm the validity and reliability of the LUNARTM-2 assay in identifying lung cancer in asymptomatic individuals. It will enhance cancer detection for those hesitant about CT scanning or in areas lacking LDCT access.
METHODS: Kaiser Permanente Colorado members scheduled for LDCT screening were contacted via email/phone and grouped into (1) suspicious lung nodules or (2) no lung nodules. Enrollment was limited to patients with Lung-RADS (Reporting and Data System, version 1.0) categories 1-3 (12-month follow-up) or category 4 (suspicious, 3-month follow-up). Members with lung nodules>30mm, hematologic malignancies, invasive cancers within 5 years, pregnancy, or cognitive impairment were excluded. After consent, Guardant Health LUNARTM-2 test kits were mailed with instructions. Blood samples were collected on the LDCT visit day or within 14 days. Survey and HER data on smoking, LDCT, and related factors were also collected.
RESULTS: Out of 872 consented individuals who provided blood samples, 84 were ineligible for the study. Among the final analytic cohort of 788 participants, 18 were diagnosed with lung cancer, 23 with other cancer, and 747 were cancer-free; all returned their biospecimens within 30 days of their LDCT scan. Participants are, on average, 68 years old, 56% female, 54% former smokers, and 87% have no personal history of cancer. Those diagnosed with lung cancer were older, had more pack-years of tobacco use, and had a higher frequency of prior cancer compared to those who remained cancer-free. Assay performance, overall and by cancer characteristics, are being calculated and will be reported in the poster.
CONCLUSIONS: This proof-of-concept study will confirm the validity and reliability of the LUNARTM-2 assay in identifying lung cancer in asymptomatic individuals. It will enhance cancer detection for those hesitant about CT scanning or in areas lacking LDCT access.
Conference/Value in Health Info
2025-05, ISPOR 2025, Montréal, Quebec, CA
Value in Health, Volume 28, Issue S1
Code
HTA55
Topic
Health Technology Assessment
Disease
SDC: Oncology, SDC: Respiratory-Related Disorders (Allergy, Asthma, Smoking, Other Respiratory)