OBJECTIVES : ALK+ NSCLC is an aggressive malignant neoplasm. The prognosis of these patients is rapidly changing due to the availability of the second generation TKI drugs for the second-line treatment post-crizotinib. This study tries to estimate the current number of patients affected by ALK+ NSCLC in Italy and provide a future estimate for patients eligible for the treatment with TKI.

METHODS : a literature review was carried out to identify the most accurate epidemiological parameters aimed to estimate the patients with ALK+ NSCLC in Italy based on the Incidence approach. An epidemiological funnel was designed starting from the Italian population (ISTAT 2019) and the incidence rates of the Italian Cancer Registry Association (AIRTUM 2019) was applied; from the total number of patients with lung cancer, the number of patients with advanced NSCLC was estimated and finally, the number of tested and positive results for ALK translocation for was identified.

RESULTS : in Italy, 42,500 patients are affected by lung cancer is (incidents); 23,562 suffering from advanced (stage III-B/IV) NSCLC. Given the increased awareness of the disease, it is estimated that the number of patients tested for ALK reaches 85% (weighted average percentage for non-squamous and squamous histology) corresponding to 17,082 total patients tested. The estimate of patients with ALK+ translocation is 3.8%, for a total amount of approximately 649 eligible patients for first-line treatment. Patients receiving crizotinib are 162 (25%) and the proportion of patients continuing therapy post-crizotinib is 80%, consistent with approximately 130 new patients eligible for a post-crizotinib second-line treatment each year.

CONCLUSIONS : ALK+ NSCLC is a particularly aggressive tumor; the affected patient undergoes frequent relapses. It is important to estimate as accurately as possible the number of incident patients affected by this disease and relative line of therapy, which may be candidates for various treatments.