Preliminary results from the Female Asian Nonsmoker Screening Study (FANSS).
Authors: Shum Elaine , Li Wenyuan , Sequist Lecia V. , Ou Sai-Hong Ignatius , Goldberg Judith D. , Chachoua Abraham , Wong Kwok-Kin 
Published: June 2023

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Background: Lung cancer (LC) is the leading cause of cancer death in Asian Americans and unfortunately the majority are diagnosed at advanced or late stages. In Asia, approximately 60-80% of female LC patients are never smokers. Current screening in the U.S. with low-dose CT (LDCT) Chest scans is offered only to current or former smokers based on the National Lung Screening Trial (NLST). The LC detection rate in NLST was 1.1%. The TALENT study, a LC screening study for high-risk nonsmokers in Taiwan reported a LC detection rate of 2.6% which included invasive adenocarcinoma (adeno), adeno in situ, minimally invasive adeno and adenosquamous carcinoma. Invasive adeno detection rate was 1.52%. We are conducting the ongoing FANSS in the U.S. to screen female Asian nonsmokers with LDCT Chest scans to evaluate the feasibility of a LC screening program in this population. We report preliminary results here. Methods: This is an IRB-approved, prospective, multicenter study (NYU, MGH, UCI). Inclusion criteria are women, age between 40-74 years old (yo), never smoked or smoked <100 cigarettes in one's lifetime and identify as from Asian descent (report ancestry or race from the continent of Asia). Participants (pts) with history of LC or treatment of any cancer <5 years ago are excluded. Following informed consent, eligible pts undergo a shared-decision making discussion prior to obtaining a baseline LDCT Chest scan, read according to Lung-RADS 1.1 with plan for annual LDCT for two additional years. A plasma-based assay to analyze cell-free DNA (cfDNA) fragments for early detection of cancer by Delfi Diagnostics (Baltimore, MD) is sent at the time of each scan. A questionnaire regarding ethnicity, family history and environmental exposures is collected at baseline. Results: From 3/1/21 to 1/15/23, 222 pts signed consent and 201 had a baseline LDCT at NYU. Age range was 40-74 yo and median age of 56.8 yo. 83 (41%) reported a family history of LC. Of 201 pts who completed a baseline LDCT, 87 (43%) were Lung-RADS 1, 101 (50%) were Lung-RADS 2, 6 (3%) were Lung-RADS 3 and 7 (3.5%) were Lung-RADS 4. 5 pts with Lung-RADS 3 and 3 pts with Lung-RADS 4 have solid, subsolid or groundglass nodules >6mm that remain in close follow-up. 3 pts were diagnosed with invasive lung adeno for a LC detection rate of 1.5%; 2 are stage IIB and 1 is stage IIIC. All pts were surgically resected, EGFR mutation positive and are receiving adjuvant osimertinib. Analysis of the cfDNA fragmentation profiles is ongoing. Conclusions: Our data shows that LC screening in Asian female nonsmokers is feasible. Preliminary results demonstrate an invasive adeno detection rate comparable with TALENT and higher than in NLST. Early detection brings new meaning with the recent FDA approval for adjuvant targeted therapy in early stage LC. The expansion of LC screening guidelines to other high-risk populations warrants further attention. FANSS is continuing to accrue at additional U.S. sites this year. Clinical trial information: NCT05164757 .