Abstract

The majority of patients with Acute Myeloid Leukemia (AML) ultimately experience relapse after achieving remission or exhibit refractory disease. Mutations in FLT3 are the most common molecular markers with an adverse prognosis in AML. The aim of this study was to estimate the Italian population with Relapsed/Refractory (R/R) FLT3 mutation-positive. A preliminary desk research was conducted to identify national disease epidemiology, treatment paths and FLT3 testing rate in different lines. Incidence and genetic mutations data were collected from AIRTUM (Italian Association of Cancer Registries) reports and National Comprehensive Cancer Network (NCCN) Guidelines. The evidences were enriched with Italian Real-World data from AML patients supplied by IQVIA (i.e. OncoView database), validated by a qualitative market research. Furthermore, a study about oncological treatments in hospitals, based on the collection of patient records, was used to achieve a comprehensive overview of the current R/R FLT3+ AML frequency. Although AML is a rare disease, it is the most common type of acute leukemia. Every year in Italy about 2,300 new patients are diagnosed. Treatment paths depend on age cluster and the current standard options typically involve intensive induction and consolidation chemotherapy in combination with targeted therapy for patients with selected disease markers. AML 2nd line R/R patients amount roughly to 900 per year. On average, 70% of AML patients are overall tested for a FLT3 mutation; 54% are tested both at diagnosis and in 2nd line. FLT3 is mutated in 30% of newly diagnosed patients, but it can also be newly acquired at the time of relapse. This study provides up to date Real-World evidence on Italian patients with R/R FLT3+ AML. These data further provide useful information about FLT3 testing rate in the Italian clinical practice and may be beneficial for improving disease management.

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