Cytisine therapy improved smoking cessation in the randomized SMILE lung cancer screening trial
Mené en Italie entre 2019 et 2020 sur 869 fumeurs participant à un dépistage du cancer du poumon, cet essai randomisé évalue l'efficacité, du point de vue de l'abstinence tabagique continue pendant 12 mois, et la tolérabilité de la cytisine
Introduction: Cytisine, a partial agonist binding nicotine acetylcholine receptor, is a promising cessation intervention. We conducted a single-centre randomized controlled trial (RCT) in Italy to assess the efficacy and tolerability of cytisine as a smoking cessation therapy among lung cancer screening participants.
Methods: From July 2019 to March 2020, the Screening and Multiple Intervention on Lung Epidemics (SMILE) RCT enrolled 869 current heavy tobacco users in a low-dose computed tomography (LDCT) screening program, with a randomized comparison of pharmacological intervention with cytisine plus counselling (N=470) versus counselling alone (N=399). The primary outcome was continuous smoking abstinence at 12 months, biochemically verified through carbon monoxide (CO) measurement.
Results: At the 12-month follow-up, the quit rate was 32.1% (151 participants) in the intervention arm and 7.3% (29 participants) in the control arm. The adjusted odds ratio (OR) of continuous abstinence was 7.2 (95% confidence interval, 4.6 to 11.2). Self-reported adverse events (AEs) occurred more frequently in the intervention arm (399 events among 196 participants) than in the control arm (230 events among 133 participants; p<0.01). The most common AEs were gastrointestinal symptoms, comprising abdominal swelling, gastritis, and constipation.
Conclusions: The efficacy and safety observed in the SMILE RCT indicate that cytisine, a very low-cost medication, is a useful treatment option for smoking cessation and a feasible strategy to improve LDCT screening outcomes with a potential benefit for all-cause mortality.
Journal of Thoracic Oncology , article en libre accès, 2021