Abstract 291P
Background
In October 2022, the national study for Lung Cancer Screening (Rete Italiana Screening Polmonare RISP) was initiated across 18 Italian centers (NCT05766046). Volunteers aged 55–75 years, active or former heavy smokers were enrolled. Active smokers were offered a cessation program combining personalized counseling (individual or group behavioral therapy) with or without cytisine, a natural alkaloid acting as a partial agonist at nicotine acetylcholine receptors whose safety and efficacy has been proven. Here, we report preliminary results of the RISP cessation program with cytisine.
Methods
Data were extracted anonymously from the centralized eCRF. Baseline variables were assessed, and comparisons were made between volunteers treated with and without cytisine. Primary outcomes included smoking abstinence at 3, 6, and 12 months with cytisine. Secondary outcomes were dropout rates, relapse, cigarette reduction, and cessation in volunteers receiving only counseling and those diagnosed with lung cancer.
Results
As of October 2022, 9,828 volunteers were enrolled; 76.4% were active smokers. Only 12.5% joined the cytisine-based program (group A), and 27.8% received counseling alone (group B). Volunteers from North-West and Central Italy showed higher adherence to both screening and cytisine-supported cessation programs (p < 0.0001). Previous quit attempts and high nicotine dependence (Fagerström test) were associated with greater participation rates in group A (p < 0.0001). No significant differences were observed by sex, age, education, pack-years, or comorbidities. Smoking cessation rates in group A at 3, 6, and 12 months were 51.0%, 49.9%, and 49.4%, respectively, compared to 7.0%, 7.0%, and 5.9% in group B, even if direct comparisons are limited. In the group A 19.4% definitively dropped out, while 23.0% reported a median 63.0% cigarette reduction. Among 113 cancer diagnoses, 73.5% were active smokers; 51.8% quit post-diagnosis, with 34.9% supported by cytisine.
Conclusions
These findings confirm the efficacy of cytisine therapy in smoking cessation and emphasize the need to improve engagement in quitting programs and optimize volunteer management in lung cancer screening.
Clinical trial identification
NCT05766046.
Legal entity responsible for the study
Fondazione IRCCS Istituto Nazionale dei Tumori.
Funding
Italian Ministry of Health.
Disclosure
S. Novello: Financial Interests, Personal, Invited Speaker: AstraZeneca, MSD, Eli Lilly, Novartis, BeiGene, Amgen, Thermo Fisher; Financial Interests, Personal, Advisory Board: BI, BMS, Pfizer, Takeda, Roche, Sanofi, Amgen, J&J; Financial Interests, Institutional, Invited Speaker, IIT: MSD, BI; Financial Interests, Institutional, Invited Speaker: AstraZeneca, AMG, Eli Lilly, Sanofi, J&J, Roche; Non-Financial Interests, Personal, Leadership Role, president of this european advocacy: WALCE; Non-Financial Interests, Personal, Member: IASLC, AIOM, ASCO. All other authors have declared no conflicts of interest.