OBJECTIVES: The aim of this research was to investigate the incidence of anaplastic lymphoma kinase-positive (ALK+) non-small cell lung cancer (NSCLC) in Italy in order to estimate the actual population affected and describe demographics and tumor-related characteristics.

METHODS: A desk research was conducted to gather national epidemiological data on ALK+ NSCLC patients; incidence data were collected from the most recent AIRTUM (Italian Association of Cancer Registries) reports (i.e. 2017). Epidemiological evidence was then enriched with real-world data from ALK+ NSCLC patients (monitoring period: 2017) supplied by IQVIA (i.e. Oncoview database), to achieve a comprehensive overview of the current NSCLC ALK+ frequency and patient characteristics.

RESULTS: In 2017, AIRTUM estimated approximately 41,800 incident cases of lung cancer and around 85-90% of them were identified as NSCLC. Furthermore, among all cases of NSCLC, ALK rearrangement was genetically characterized with a frequency around 4-7%. ALK+ NSCLC was prevalent between 51 and 60 years old patients and the majority of them were ex-smokers or non-smokers/light smokers, with no gender differences. Around 80% of patients showed a malignant neoplasm within the G2-G4 grades (measure of cell anaplasia), which are usually linked to the most aggressive tumor types. In accordance with the disease high severity, these patients showed a pluri-metastatic tumor, spreading in uncommon locations if compared to other NSCLC types.

CONCLUSIONS: This study provides contemporary real-world evidence on Italian patients with ALK+ NSCLC, which shows a more advanced and severe disease. These data provide useful information for screening ALK+ cases in clinical practice and may be beneficial for future research on the efficacy of ALK inhibitors.