Dogu, Mehmet HilmiTekgunduz, Ali Irfan EmreDeveci, BurakKorkmaz, GultenComert, MeldaSevindik, Omur GokmenYokus, Osman2024-05-192024-05-1920232035-3006https://doi.org10.4084/MJHID.2023.031https://hdl.handle.net/20.500.12713/5167Background And Objectives: Gilteritinib (XOSPATA (R), Astellas) is a type I oral FLT3 inhibitor, a tyrosine kinase AXL inhibitor, involved in both c-Kit and FMS-like tyrosine kinase 3 (FLT3) resistance. In the phase 3 ADMIRAL trial, gilteritinib was compared with the standard of care in (R/R) acute myeloid leukemia (AML) patients who harbored any FLT3 mutation and showed superior efficacy with regard to response and survival. Objectives: This research aimed to investigate the real-life efficacy and safety of gilteritinib in FLT3-positive R/R AML patients who were treated as a part of an early access program held in Turkey in April 2020 (NCT03409081). Results: The research included 17 R/R AML patients who had received gilteritinib from seven centers. The overall response rate was 100%. The most common adverse events were anemia and hypokalemia (7 patients, 41.2%). Grade 4 thrombocytopenia was observed in one patient only (5.9%), leading to permanent treatment discontinuation. Patients with peripheral edema had a 10.47 (95% CI: 1.64-66.82) times higher risk of death than those without peripheral edema (p<0.05). Conclusion: This research showed that patients with febrile neutropenia and peripheral edema were at a high risk of death when compared to patients without febrile neutropenia and peripheral edema.eninfo:eu-repo/semantics/openAccessGilteritinibAcute Myeloid Leukemia (Aml)Early AccessReal-Life DataResponsePrognosisArticle15137180209WOS:0009830874000012-s2.0-85160615870N/A10.4084/MJHID.2023.031Q2