OBJECTIVES: this real-world analysis aims to estimate the epidemiology of early-stage non-small-cell lung carcinoma(eNSCLC), patients' characteristics, and economic burden in a clinical practice setting in Italy.

METHODS: an observational analysis was performed using administrative databases(ADB) linked to pathological anatomy-data(APD), covering around 2.5mln health-assisted individuals. From 2015-mid2021(study-period) eNSCLC patients(stage II-IIIA) were identified by this algorithm: i)from ADB, patients with lung cancer hospitalization undergoing lung surgery were selected; ii)among them, those receiving chemotherapy(identifying stage II-III), without metastasis (excluding stage IV), and without durvalumab(excluding stage IIIB-C), were proxied as stage II-IIIA; iii)among them, patients with NSCLC morphology-based diagnosis of stage II-IIIA (by ADP-linking, using staging-system available at patient’inclusion) were included. The index-date was the lung surgery-date; patients were characterized during 12-months before index-date and followed-up from index-date until study-period ending. Patients were stratified into those presenting loco-regional or metastatic recurrence during follow-up, and annualized healthcare direct-costs covered by the Italian National Health System(INHS) were estimated.

RESULTS: on 2019-2020, the prevalence of eNSCLC was 104.3-117.1/million health-assisted subjects, and the annual incidence was 38.6-30.3/million. Data projected to Italian population estimated 6,206(2019) and 6,967(2020) prevalent and 2,297(2019) and 1,803(2020) incident cases. Overall, 458 eNSCLC patients were included, aged 67.4±8.4 years(60.5% males). At 24-months after surgery, 45.6% patients had recurrence (6% loco-regional and 39.6% metastatic-recurrence). Healthcare total direct-costs/patients averaged 11,714€ in no-recurrence and 21,577€ and 24,104€ in loco-regional and metastatic-recurrence patients, respectively.

CONCLUSIONS: This real-world analysis provides insights into the epidemiology of eNSCLC, patients' characteristics, and economic burden, in Italy. About 45% of patients had a recurrence, and in recurrence patients total direct costs covered by INHS were almost 2-fold those of no-recurrence patients. The results of the present analysis could suggest that for the management of eNSCLC an unmet clinical need remains, and therapeutic optimization at early stages is required to improve the disease's clinical and economic burden.