Gilteritinib (XOSPATA (R)) in Turkey: Early access program results

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dc.authorid0000-0001-9636-4113
dc.contributor.authorDoğu, Mehmet Hilmi
dc.contributor.authorTekgündüz, Ali İrfan Emre
dc.contributor.authorDeveci, Burak
dc.contributor.authorKorkmaz, Gülten
dc.contributor.authorCömert, Melda
dc.contributor.authorSevindik, Ömür Gökmen
dc.contributor.authorYokuş, Osman
dc.contributor.authorSerin, İstemi
dc.date.accessioned2023-05-26T11:02:10Z
dc.date.available2023-05-26T11:02:10Z
dc.date.issued2023
dc.departmentİstanbul Medipol Üniversitesi, Tıp Fakültesi, Dahili Tıp Bilimleri Bölümü, İç Hastalıkları Ana Bilim Dalı
dc.description.abstractBackground 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.
dc.identifier.citationDoğu, 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.2023.031
dc.identifier.doi10.4084/MJHID.2023.031
dc.identifier.issn2035-3006
dc.identifier.issue1
dc.identifier.pmid37180209
dc.identifier.scopus2-s2.0-85160615870
dc.identifier.scopusqualityQ2
dc.identifier.urihttps://doi.org/10.4084/MJHID.2023.031
dc.identifier.urihttps://hdl.handle.net/20.500.12511/10979
dc.identifier.volume15
dc.identifier.wos000983087400001en_US
dc.identifier.wosqualityQ3
dc.indekslendigikaynakWeb of Science
dc.indekslendigikaynakScopus
dc.indekslendigikaynakPubMed
dc.institutionauthorSevindik, Ömür Gökmen
dc.language.isoen
dc.publisherMattioli 1885
dc.relation.ispartofMediterranean Journal of Hematology and Infectious Diseasesen_US
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanı
dc.rightsAttribution-NonCommercial 4.0 International*
dc.rightsinfo:eu-repo/semantics/openAccess
dc.rights.urihttps://creativecommons.org/licenses/by-nc/4.0/*
dc.subjectGilteritinib
dc.subjectAcute Myeloid Leukemia (AML)
dc.subjectEarly Access
dc.subjectReal-Life Data
dc.subjectResponse
dc.subjectPrognosis
dc.titleGilteritinib (XOSPATA (R)) in Turkey: Early access program results
dc.typeArticle

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