Doğu, Mehmet HilmiTekgündüz, Ali İrfan EmreDeveci, BurakKorkmaz, GültenCömert, MeldaSevindik, Ömür GökmenYokuş, OsmanSerin, İstemi2023-05-262023-05-262023Doğu, M. H., Tekgündüz, A. İ. E., Deveci, B., Korkmaz, G., Cömert, M., Sevindik, Ö. G. ... Serin, İ. (2023). Gilteritinib (XOSPATA (R)) in Turkey: Early access program results. Mediterranean Journal of Hematology and Infectious Diseases, 15(1). https://doi.org/10.4084/MJHID.2023.0312035-3006https://doi.org/10.4084/MJHID.2023.031https://hdl.handle.net/20.500.12511/10979Background 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.enAttribution-NonCommercial 4.0 Internationalinfo:eu-repo/semantics/openAccessGilteritinibAcute Myeloid Leukemia (AML)Early AccessReal-Life DataResponsePrognosisArticle15110.4084/MJHID.2023.031Q30009830874000012-s2.0-8516061587037180209Q2