Background. In Italy, lung cancer is the second most common malignancy and the leading cause of cancer-related death among men, while it is the third most common malignancy and the second leading cause of cancer- related death among women. The 5-year survival rate is approximately 16% for men and 23% for women. The main risk factor for lung cancer is cigarette smoking: it is estimated that 90% of lung cancer cases are associated with tobacco use. The proportion of Italian citizens who report smoking regularly is around 22%. Considering that in approximately half of cases lung cancer is already metastatic at diagnosis, and given its high mortality rate, the RISP project (Rete Italiana Screening Polmonare) was launched in 2022. The project involves screening a cohort of high-risk individuals using low-dose computed tomography (LDCT), with the aim of enabling early diagnosis and improving survival outcomes for lung cancer patients. Aim of the study. The primary objective is to describe the diagnostic and therapeutic pathway of patients diagnosed with malignant lung neoplasms within the framework of the RISP program at the Istituto Oncologico Veneto. Secondary objectives include describing the demographic and clinical characteristics of the enrolled population, as well as the outcomes of the smoking cessation program in Veneto. Materials and methods. 480 individuals at high risk for lung cancer were enrolled. Participants were between 55 and 75 years of age (median age was 62 years old), current smokers or former smokers who had quit within the previous 15 years, with a smoking history of at least 30 pack-years, and no history of malignancy within the past 5 years. These subjects were randomized in a 1:1 ratio into two groups: group A underwent annual LDCT screening, while group B underwent biennial LDCT screening. Patients with negative results continued within the screening program, whereas those with positive findings were referred for further diagnostic evaluation and any necessary therapeutic intervention. The characteristics of the enrolled subjects were investigated using descriptive analyses. Comparison analysis was performed using Student’s t-test, Chi-square test (χ2 test) and Fisher’s test. Median follow-up was estimated using the reverse Kaplan–Meier method. Statistical significance was defined for p-values < 0.05. Results. In the cohort enrolled at the Istituto Oncologico Veneto, 2.5% of recruited subjects were diagnosed with lung cancer over the 3-year screening program: 9 adenocarcinomas, 1 squamous cell carcinoma, 1 large-cell neuroendocrine carcinoma (LCNEC) and 1 typical lung carcinoid. The stage was: 66.8% stage I, 16.6% stage II, 16.6% stage III; no patients showed metastatic spread. At the time of data collection, the median follow-up was 32 months and the median event-free survival (EFS) was 31 months; no patients died and the median overall survival (OS) had not been reached. No statistically significant differences were observed between group A and group B in terms of detecting positive patients. Conclusions. Within the study population, lung cancer was diagnosed at a localized or locally advanced stage, confirming the secondary prevention purpose underlying the RISP project. The implementation of a permanent LDCT-based screening program for populations at high risk of lung cancer may help reduce late-stage diagnoses and mortality associated with this disease.
Presupposti dello studio. In Italia, il tumore del polmone è la seconda neoplasia più frequente e la prima causa di morte per cancro negli uomini, mentre risulta la terza più frequente e la seconda causa di morte per cancro nelle donne. La sopravvivenza a 5 anni riguarda il 16% degli uomini e il 23% delle donne. Il principale fattore di rischio per il tumore del polmone è il fumo di sigaretta: si ritiene che il 90% dei casi di neoplasia polmonare sia associato all’abitudine tabagica. La percentuale di cittadini italiani che dichiara di fumare abitualmente si aggira intorno al 22%. In considerazione del fatto che in metà dei casi il tumore del polmone si presenta già in stadio metastatico e in considerazione dell’elevata mortalità, nel 2022 ha avuto inizio il progetto RISP (Rete Italiana Screening Polmonare). Questo progetto prevede di sottoporre un campione di soggetti ad alto rischio ad un esame di screening tramite tomografia computerizzata a basso dosaggio (LDCT), al fine di fornire una diagnosi precoce e un aumento della sopravvivenza per neoplasie del polmone. Scopo dello studio. L’obiettivo primario è la descrizione del percorso diagnostico e terapeutico dei pazienti che hanno ricevuto diagnosi di neoplasia maligna del polmone nell’ambito del programma RISP nell’Istituto Oncologico Veneto. Obiettivi secondari sono descrivere le caratteristiche demografiche e cliniche della popolazione globale arruolata e i risultati del programma di disassuefazione dal fumo. Materiali e metodi. Sono stati reclutati 480 soggetti ad alto rischio per tumore del polmone, di età compresa tra 55 e 75 anni (età mediana 62 anni), fumatori attivi o ex fumatori da meno di 15 anni di almeno 30 pack-years, senza storia di neoplasie negli ultimi 5 anni. Questi soggetti sono stati randomizzati in rapporto 1:1 in due bracci: braccio A, che ha svolto LDCT annualmente, e braccio B, ogni 2 anni. I pazienti con esito negativo hanno proseguito il programma di screening; quelli positivi sono stati presi in carico per l’approfondimento diagnostico e l’eventuale intervento terapeutico necessario. Le caratteristiche dei soggetti arruolati sono state indagate utilizzando analisi descrittive, percentuali, mediane e range interquartili. Per l’analisi di confronto sono stati usati il t-test di Student, il test del χ2 e il test di Fisher. La mediana di follow-up è stata ricavata tramite reverse Kaplan-Meier. La significatività statistica è stata definita per valori di p<0.05. Risultati. Nella casistica dell’Istituto Oncologico Veneto, il 2,5% dei soggetti reclutati ha sviluppato un tumore del polmone nell’arco dei 3 anni di programma di screening: 9 adenocarcinomi, 1 carcinoma squamocellulare, 1 carcinoma neuroendocrino a grandi cellule (LCNEC) e 1 carcinoide tipico. Lo stadio era: 66.8% primo, 16.6% secondo, 16.6% terzo; nessun paziente mostrava secondarismi. Al momento di raccolta dati, la mediana di follow-up era di 32 mesi e quella di event free survival (EFS) di 31 mesi; nessun paziente è deceduto e la mediana di overall survival (OS) non è stata raggiunta. Non sono state evidenziate differenze significative tra il braccio A e il braccio B in termini di rilevamento di soggetti positivi. Conclusioni. La diagnosi di neoplasia polmonare, all’interno del campione oggetto di studio, è avvenuta in stadio localizzato o localmente avanzato, confermando l’intento di prevenzione secondaria che è all’origine del progetto RISP. L’istituzione di un programma di screening permanente per popolazione ad alto rischio per tumore del polmone con LDCT può garantire una riduzione delle diagnosi tardive e della mortalità associate a questa patologia.
Prevenzione secondaria per il tumore del polmone: risultati del progetto RISP in Veneto
CAVERZAN, JACOPO
2025/2026
Abstract
Background. In Italy, lung cancer is the second most common malignancy and the leading cause of cancer-related death among men, while it is the third most common malignancy and the second leading cause of cancer- related death among women. The 5-year survival rate is approximately 16% for men and 23% for women. The main risk factor for lung cancer is cigarette smoking: it is estimated that 90% of lung cancer cases are associated with tobacco use. The proportion of Italian citizens who report smoking regularly is around 22%. Considering that in approximately half of cases lung cancer is already metastatic at diagnosis, and given its high mortality rate, the RISP project (Rete Italiana Screening Polmonare) was launched in 2022. The project involves screening a cohort of high-risk individuals using low-dose computed tomography (LDCT), with the aim of enabling early diagnosis and improving survival outcomes for lung cancer patients. Aim of the study. The primary objective is to describe the diagnostic and therapeutic pathway of patients diagnosed with malignant lung neoplasms within the framework of the RISP program at the Istituto Oncologico Veneto. Secondary objectives include describing the demographic and clinical characteristics of the enrolled population, as well as the outcomes of the smoking cessation program in Veneto. Materials and methods. 480 individuals at high risk for lung cancer were enrolled. Participants were between 55 and 75 years of age (median age was 62 years old), current smokers or former smokers who had quit within the previous 15 years, with a smoking history of at least 30 pack-years, and no history of malignancy within the past 5 years. These subjects were randomized in a 1:1 ratio into two groups: group A underwent annual LDCT screening, while group B underwent biennial LDCT screening. Patients with negative results continued within the screening program, whereas those with positive findings were referred for further diagnostic evaluation and any necessary therapeutic intervention. The characteristics of the enrolled subjects were investigated using descriptive analyses. Comparison analysis was performed using Student’s t-test, Chi-square test (χ2 test) and Fisher’s test. Median follow-up was estimated using the reverse Kaplan–Meier method. Statistical significance was defined for p-values < 0.05. Results. In the cohort enrolled at the Istituto Oncologico Veneto, 2.5% of recruited subjects were diagnosed with lung cancer over the 3-year screening program: 9 adenocarcinomas, 1 squamous cell carcinoma, 1 large-cell neuroendocrine carcinoma (LCNEC) and 1 typical lung carcinoid. The stage was: 66.8% stage I, 16.6% stage II, 16.6% stage III; no patients showed metastatic spread. At the time of data collection, the median follow-up was 32 months and the median event-free survival (EFS) was 31 months; no patients died and the median overall survival (OS) had not been reached. No statistically significant differences were observed between group A and group B in terms of detecting positive patients. Conclusions. Within the study population, lung cancer was diagnosed at a localized or locally advanced stage, confirming the secondary prevention purpose underlying the RISP project. The implementation of a permanent LDCT-based screening program for populations at high risk of lung cancer may help reduce late-stage diagnoses and mortality associated with this disease.| File | Dimensione | Formato | |
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https://hdl.handle.net/20.500.12608/109103